Sleep Disorders

Alfresa Pharma and Mitsubishi Tanabe Pharma : Approval of Additional Indication for MODIODAL® Tablets 100 mg a Sleep Disorder Treatment

2012-01-25T14:39:00.000-08:00

November 25, 2011 - Alfresa Holdings Corporation (head office: Tokyo, Representative Director & President: Denroku Ishiguro) and Mitsubishi Tanabe Pharma Corporation (head office: Osaka, President & CEO: Michihiro Tsuchiya) announced that Alfresa Pharma Corporation (head office: Osaka, President & CEO: Kenichiro Iwaya), a subsidiary of Alfresa Holdings engaged in manufacture of pharmaceuticals etc., received approval of a partial change in the indications of MODIODAL® Tablets 100 mg (generic name: modafinil), a sleep disorder treatment, that has been jointly developed in Japan by Alfresa Pharma and Mitsubishi Tanabe Pharma.

Since March 2007, MODIODAL® has been jointly marketed by the two companies as a treatment for excessive daytime sleepiness associated with narcolepsy, a sleep disorder characterized by intolerable daytime sleepiness. The new indication, approved for the first time in Japan, is “excessive diurnal sleepiness accompanied with obstructive sleep apnea syndrome (OSAS) under treatment for airway obstruction by continuous positive airway pressure (CPAP) therapy and the like”. The two companies expect MODIODAL® will contribute to improve quality of life of patients whose daily lives would otherwise be disrupted by excessive diurnal sleepiness in OSAS as well as narcolepsy.

MODIODAL® is currently approved in more than 30 countries in the world, and in seven countries, including the US, it is marketed with approval for the new indication... [PDF] Alfresa's Press Release - [PDF] Mitsubishi Tanabe Pharma's Press Release -

EISAI RECEIVES APPROVAL TO MARKET INSOMNIA TREATMENT LUNESTA® IN JAPAN

2012-01-18T09:08:00.000-08:00

January 18, 2012 - Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito, “Eisai”) announced that it received approval from Japan's Ministry of Health, Labour and Welfare (MHLW) on January 18, 2012 to market Lunesta® (eszopiclone), a product the company has been developing in Japan, as a treatment for insomnia.

Lunesta, originally discovered and developed by Sunovion Pharmaceuticals Inc. (“Sunovion”; formerly Sepracor Inc., “Sepracor”; a U.S. subsidiary of Dainippon Sumitomo Pharma Co., Ltd.), has been marketed in the United States since April 2005. The agent was approved as the first insomnia treatment not to have restrictions on its length of use, and is widely used by individuals suffering from insomnia. Eisai has been pursuing the development of Lunesta since acquiring the exclusive rights to develop and market it in Japan from Sunovion (at the time known as Sepracor) in July 2007. The company submitted a marketing authorization application to the MHLW in November 2010.

Lunesta is a non-benzodiazepine type GABAA agonist that is believed to enhance GABA activity while exerting hypnotic and sedative effects. Results from clinical studies conducted in Japan and overseas demonstrated that the agent is effective in those patients who have trouble falling asleep or wake up often during the night, two major symptoms of insomnia. A distinctive feature of Lunesta is that patients do not experience clinically problematic issues such as dependency or carry-over effects or develop a tolerance (experience diminished efficacy) with long-term use... Eisai's Press Release -

Pfizer : Positive Results From Phase 3 Trial Of Lyrica (pregabaline) Capsules CV In Restless Legs Syndrome

2012-01-09T15:14:00.000-08:00

December 16, 2011 - Top-Line Results Show Lyrica Met All Co-Primary Endpoints -
Pfizer Inc. (NYSE: PFE) announced that a Phase 3 study for Lyrica (pregabalin) in patients with Restless Legs Syndrome (RLS) met each of its three co-primary endpoints, showing significant benefit as compared with placebo and pramipexole. Pfizer will continue to further analyze these top-line results.

The study, A0081186, was a randomized, double-blind, 12-month trial. It enrolled more than 700 patients, who received either a placebo, Lyrica at 300 mg/day, pramipexole at 0.25 mg/day or pramipexole at 0.5 mg/day.

Patients treated with Lyrica experienced a statistically significant improvement compared with placebo in RLS symptom severity as measured by the International Restless Leg Group Rating Scale following 12 weeks of treatment. The Lyrica group also demonstrated a statistically significant improvement following 12 weeks of treatment in the proportion of patients responding to treatment compared with those on placebo as measured by the Clinical Global Impression Improvement scale. In addition, Lyrica treatment resulted in a statistically significant reduction in the rate of augmentation (worsening of RLS symptoms that occur after starting a medication to treat RLS) compared with pramipexole 0.5 mg/day over 12 months.

The results for this study indicate that the most common adverse events in Lyrica-treated patients were dizziness, somnolence, fatigue, headache and nasopharyngitis (inflammation of the nasal cavity and throat). The adverse event profile is consistent with that known for pregabalin.

Restless Legs Syndrome is a neurological condition that is characterized by an unpleasant irresistible urge to move the legs and, in severe cases, other parts of the body. The symptoms have a circadian pattern and occur mostly in the evening and bedtime. It often results in difficulty falling or staying asleep and can result in periodic limb movements while sleeping, causing partial awakenings that disrupt sleep. RLS has profound negative impact on patients’ quality of life... Pfizer's Press Release -

Impax Pharmaceuticals : Phase IIb Trial of IPX159 in Restless Legs Syndrome

2011-12-20T06:59:00.000-08:00

Dec. 19, 2011-- Impax Pharmaceuticals, the branded products division of Impax Laboratories, Inc. (NASDAQ: IPXL), announced that it has initiated a Phase IIb trial of its drug candidate IPX159 in patients with moderate to severe Restless Legs Syndrome (RLS).

“We are pleased to advance IPX159 to this Phase IIb study, which will help establish its clinical profile in moderate to severe RLS patients. We look forward to reporting the results from this study and providing an update on the program in mid-2013,” said Suneel Gupta, Ph.D., chief scientific officer, Impax Pharmaceuticals.

The Phase IIb study is a multicenter, randomized, double-blind, placebo-controlled, safety and efficacy study to evaluate IPX159 in the treatment of moderate to severe RLS. The trial is expected to randomize approximately 120 adult subjects who will receive either IPX159 or placebo and will be treated for up to 11 weeks. The trial will be conducted at multiple sites in North America. The primary endpoint is the International Restless Legs Syndrome Study Group (IRLSSG) Rating Scale... Impax Pharmaceuticals' Press Release -

Pierre Fabre Médicament : JONCIA® milnacipran treating fibromyalgia in Australia

2011-12-01T07:58:00.001-08:00

On November 17 in Australia, Pierre Fabre Médicament obtained marketing authorization for Joncia® milnacipran in the treatment of fibromyalgia.

Australian drug regulation agency the Therapeutic Goods Administration (TGA) has granted Pierre Fabre Médicament marketing authorization for Joncia® milnacipran, a molecule used in the treatment of fibromyalgia. First discovered by Pierre Fabre's research teams, milnacipran has since been developed for this indication in collaboration with Cypress Bioscience (acquired by Royalty Pharma) and Forest Laboratories.

Approval was granted on the basis of three 3-month Phase III clinical trials conducted in the United States and Europe. These studies, involving over 3,000 patients evaluated using a self-assessment questionnaire, revealed that 100 mg and 200 mg doses of milnacipran resulted in a clinically significant reduction in pain, an overall improvement in symptoms, and a significant improvement in fatigue and sleep. In addition Milnacipran was generally well tolerated with most adverse events being recorded as mild to moderate, and the TGA has announced a positive Joncia® milnacipran benefit/risk ratio... Pierre Fabre Médicament's Press Release -

Circadiance : Revolutionary New CPAP Tube

2011-11-14T15:12:00.001-08:00

November 7, 2011 - Lightweight and flexible design provides better overall user experience -

Building on the success of their revolutionary soft cloth nasal SleepWeaver CPAP (Continuous Positive Airway Pressure) mask, Circadiance is proud to introduce a mask tube so lightweight and flexible, that CPAP users will hardly know it’s there.

Used in the treatment of sleep apnea, the new SleepWeaver Feather Weight Tube from Circadiance complements the CPAP mask with a 15-millimeter hose composed of revolutionary, lightweight material that reduces the weight at the mask connection point, making the hose less likely to pull and disrupt the seal. The new tube also extends the hose length by 1.5 feet.

“Our new hose is lighter and more flexible than standard CPAP hoses,” says Circadiance Director of Engineering, Ron Mahofski. “It also includes smaller lightweight connectors, which reduce the pull between the hose and the mask.”

Also, unlike the majority of hoses, the SleepWeaver Feather Weight Tube offers the unique ability to stretch, providing a more forgiving connection to CPAP devices. It can also be used as a quick release.

“These features give users the full benefit of CPAP therapy so they can enjoy a deep, restorative sleep,” says Mahofski.

Launching in November 2011, the new tube is designed to fit any CPAP mask with a 22-millimeter connection... Circadiance's News -

Midmark Corporation partners with Cleveland Medical Devices Inc., introducing Portable Home Sleep Testing Monitor...

2011-10-25T14:30:00.000-07:00

October 17, 2011 - Midmark Corporation partners with Cleveland Medical Devices Inc., introducing Portable Home Sleep Testing Monitor that enables patients to be tested for Obstructive Sleep Apnea in comfort of their own homes

- The FDA-cleared, physician-prescribed SleepView® provides a convenient and cost-effective alternative for diagnosing the most common type of breathing-related sleep disorder -

Midmark Corporation, a trusted leader in digital diagnostic devices for ambulatory care, announced a partnership with Cleveland Medical Devices, a leader in sleep diagnostics technology, launching the Midmark SleepView® Monitor and SleepViewSM Portal.

The Midmark SleepView Monitor developed by Cleveland Medical Devices is the market’s smallest and lightest portable home sleep monitor that meets the American Academy of Sleep Medicine’s recommended channel set for Type III monitors.

The Midmark SleepView Portal offers prescribing physicians secure, HIPAA compliant online access to registered polysomnographic technologists and board-certified sleep physicians who provide scoring, professional interpretation and treatment recommendations.

Obstructive sleep apnea (OSA) is a repeated interruption of normal breathing during sleep due to a collapse of the upper airway. It is estimated to impact as many people as asthma and diabetes; yet, 85 percent of the population with the disease is undiagnosed and untreated. "There is a real need in the healthcare industry to address this large and growing clinical concern," said Tom Treon, senior product manager for Midmark. "We want to improve the effectiveness and efficiency of care for patients with OSA by providing another diagnostic option, which enables patients to be tested in the comfort of their own bed and convenience of their own home for a more natural night of sleep."

OSA does in fact hold serious health and economic consequences. Numerous studies link OSA to major chronic diseases such as stroke, heart failure, diabetes, obesity, hypertension and increased odds of serious car crash injuries. Economic studies have also shown that people with untreated OSA have 200 percent higher healthcare costs than similar people without OSA. Midmark has entered into a strategic partnership with Cleveland Medical Devices Inc. (CleveMed) for licensing of the SleepView technology. Established in 1990, CleveMed is a leader in sleep diagnostics technology with products serving sleep labs, institutional and home settings... Cleveland Medical Devices' press Release -

Philips : Home oxygen measurement solution for sleep and ventilation launched at ERS 2011

2011-10-14T02:39:00.000-07:00

September 29, 2011 - Philips’ latest launch reinforces its commitment to providing monitoring solutions that support patient care at home - Home oxygen measurement solution for sleep and ventilation launched at ERS 2011 - Royal Philips Electronics (NYSE: PHG, AEX: PHI) has launched the new Oximetry Module, a home oxygen measurement device designed to monitor people diagnosed with respiratory disorders such as sleep apnea and chronic obstructive pulmonary disease (COPD) and to record their blood oxygen level by means of a single finger probe.

The Oximetry Module, which was launched during the 2011 Congress of the European Respiratory Society (ERS) in Amsterdam, is designed to help physicians to better determine whether complex respiratory events are present during a person’s period of sleep at home.

“Non-invasive ventilation (NIV) (or home ventilation) has been demonstrated to be effective treatment in some forms of respiratory failure. When starting NIV, it seems desirable to verify whether this particular form of treatment is effective and has no untoward effects. Greater insight, provided by simple cost effective monitoring tools like oximetry and other signals obtained from non-invasive positive pressure ventilation (NPPV) devices; help identify issues early in the patient’s therapy. This subsequently improves their long term outcomes and quality of life... Philips' Press Release -

Siesta Medical : 510(k) Clearance for Encore™ System

2011-10-03T14:09:00.000-07:00

September 12, 2011 - Siesta Medical, Inc. (Private), a developer of minimally invasive surgical solutions for obstructive sleep apnea (OSA), announced today that it has received FDA 510(k) clearance for its Encore™ Tongue Suspension System for the treatment of obstructive sleep apnea.

Obstructive sleep apnea (OSA) is a major heath problem in the United States. As many as 17 million people in the United States have moderate to severe OSA, which is characterized by frequent awakening during sleep, heavy snoring and daytime sleepiness. If left untreated, OSA has been implicated in the increased risk for cardiovascular disease, including hypertension and heart failure. Despite its prevalence and role as a cardiovascular risk factor, OSA remains largely under diagnosed.

The first line and most common treatment for OSA is continuous positive airway pressure (CPAP) treatment, utilized by an estimated three million Americans. While effective, CPAP is difficult for patients to use.

Surgical therapy for OSA is less common than CPAP therapy. Although there are approximately one million new diagnoses of OSA in the U.S. each year, there are only approximately 100,000 surgical treatments for OSA performed annually. Surgery is less prevalent as most current procedures are not highly effective, are painful to the patient and do not address tongue based obstructions. The tongue is implicated in approximately 80 percent of OSA.

The Encore™ Tongue Suspension System

The EncoreTM System is used in a minimally invasive surgical procedure where the tongue is suspended forward with the intent of preventing collapse of the airway during sleep. The procedure is performed under local or general anesthesia by Ear, Nose and Throat Specialists, also known as Otolaryngologists. During the procedure, an intra-tissue suture passer is used to place a suspension loop in the tongue which is then attached to the base of the chin with a knotless bone anchor. The EncoreTM System greatly simplifies tongue suspension and provides the surgeon excellent control of positioning and tensioning of the suspension loop.

Siesta Medical is currently planning a multi-center U.S. post-marketing study... [PDF] Siesta Medical's Press Release -

Eiken : First Field-based Molecular Diagnostic Test for African Sleeping Sickness in Sight

2011-09-26T13:59:00.000-07:00

15 September 2011 – The Geneva-based not-for-profit foundation FIND and Japanese diagnostics company Eiken announced that a next-generation molecular test designed specifically for sleeping sickness – a deadly parasitic disease also known as human African trypanosomiasis (HAT) - is ready to enter accelerated field trials in sites across the Democratic Republic of Congo and Uganda. If all goes well, the LAMP (Loop-mediated Isothermal Amplification) test - which has completed design and development phases - will be available for clinical use in 2012.

The announcement was made at the 31st biennial of the International Scientific Council for Trypanosomiasis Research and Control (ISCTRC), in Bamako, Mali.

Designed to be suitable for use in rural African settings where the disease is most common, the LAMP test promises to dramatically improve the ability to confirm a diagnosis of sleeping sickness - even when parasites are present in low numbers - through detection of the parasite's DNA in patient samples. FIND is also exploring LAMP's utility as a tool to confirm cure after treatment of HAT, which would significantly reduce the follow-up period, and could eliminate the need for repeated lumbar punctures.

If not diagnosed and treated early, sleeping sickness inexorably progresses to a stage where the parasites enter the brain, making treatment more difficult and the likelihood of irreversible neurological damage more likely... [PDF] Eiken's Press Release -

Natus Acquires Embla, Leading Sleep Diagnostic Company

2011-09-19T14:15:00.000-07:00

Sep 16, 2011 - Acquisition expected to add $0.08 to 2012 non-GAAP Earnings Per Share -- Natus Medical Incorporated (Nasdaq:BABY) announced that it has acquired Embla Systems LLC, a leader in the development, manufacturing, and sales of devices used in the diagnosis of sleep apnea. Embla is the largest company in the world focused solely on sleep diagnostics (Polysomnography or PSG and Home Sleep Testing). The company offers a wide spectrum of innovative sleep diagnostic solutions including Embletta home sleep testing devices and three leading PSG platforms: Sandman, REMbrandt, and RemLogic, and Enterprise Sleep Business Management Systems. This breadth of product offerings provides a unique set of tools to help optimize the efficiency of sleep labs.

Natus acquired all outstanding shares of Embla capital stock for $16.1 million in cash, exclusive of direct costs of the acquisition. Embla reported revenue of approximately $30 million for its fiscal year ended December 31, 2010.

Natus expects the acquisition will be accretive to earnings in 2012, adding $0.08 to non-GAAP earnings per share for the year. The non-GAAP results will exclude amortization of acquired intangible assets and potential restructuring and other one-time charges related to the acquisition... Natus Medical's Press Release -

Chelsea Therapeutics : New Patent for Use of Droxidopa in Fibromyalgia

2011-09-06T13:42:00.001-07:00

Sept. 6, 2011 -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) announced that the United States Patent and Trademark Office has issued U.S. Patent No. 8,008,285 entitled "Droxidopa and pharmaceutical composition thereof for the treatment of fibromyalgia." The claims of the patent are related to methods of reducing pain associated with fibromyalgia by administering droxidopa alone, or in combination with other specified medications, to patients diagnosed with fibromyalgia. Chelsea recently completed enrollment of 120 patients in its Phase II trial of droxidopa for the treatment of fibromyalgia. Top-line results of the trial are expected by the end of the year.

Fibromyalgia is a chronic and debilitating condition that is characterized by widespread pain and stiffness throughout the body, accompanied by severe fatigue, insomnia and mood symptoms. While the precise etiology of fibromyalgia remains unknown, current research has focused on the role of norepinephrine (NE) reuptake and availability in the central nervous system. NE, a widely used neurotransmitter in the central and peripheral nervous systems has long been linked to both chronic pain and depression. Droxidopa, a synthetic amino acid, is converted by the body into norepinephrine and, as a prodrug of NE, provides replacement therapy for NE deficiency. While NE, as a catecholamine does not penetrate the blood-brain barrier, droxidopa, as a neutral amino acid, is able to do so thus providing both a peripheral and central affect on circulating NE levels... Chelsea Therapeutics' Press Release -

Apnex Medical : FDA Approval for Pivotal Clinical Study for Obstructive Sleep Apnea

2011-08-04T13:56:00.000-07:00

Aug. 2, 2011 - Apnex Medical, Inc., received investigational device exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to begin a clinical study to evaluate the safety and effectiveness of its Hypoglossal Nerve Stimulation (HGNS®) System to treat obstructive sleep apnea (OSA). Data from this clinical study are intended to support the Pre-Market Approval (PMA) application for the HGNS System to the FDA.
"Many patients who suffer from OSA are unable to tolerate existing therapies such as continuous positive airway pressure (CPAP). The HGNS System provides a fundamentally new approach to the treatment of OSA. This study will help us further understand the potential role this device will have in treating the millions of people who suffer from OSA," said the study's co-principal investigator, Dr. Atul Malhotra, Clinical Chief, Division of Sleep Medicine, Brigham and Women's Hospital.
Sponsored by Apnex Medical, the Apnex Clinical Study is a prospective, randomized, multi-center clinical trial. It is being conducted in leading medical centers in the United States, Europe and Australia. The trial is designed to demonstrate the safety and effectiveness of the HGNS therapy in treating patients with moderate to severe OSA. To be enrolled in the study patients must not have received lasting benefit from CPAP or other OSA treatments... [PDF] Apnex Medical's Press Release -

Meda and Valeant Pharmaceuticals : Sublinox approved in Canada

2011-07-26T14:57:00.000-07:00

July 25 2011 – The insomnia drug Sublinox (Edluar) has been approved in Canada. Meda and its partner Valeant expect to begin the launch in the fourth quarter 2011.

Sublinox will be marketed by the joint venture between Meda and Valeant, Meda Valeant Pharma Canada Inc. Meda has global rights to the drug and markets it in the USA since 2009 under the name Edluar. Orexo, who has developed the drug, is entitled to royalties on sales.

The approval is for short-term treatment of insomnia. Sublinox is based on Orexo's sublingual tablet technology. The drug is placed under the tongue where it rapidly disintegrates and the active substance zolpidem is absorbed through the oral mucosa... Orexo's Press Release - Meda's Press Release - Valeant's Press Release -

ResMed : Acquisition of BiancaMed

2011-07-18T14:35:00.000-07:00

July 6, 2011 - ResMed Inc. (NYSE: RMD and ASX: RMD), a leading developer, manufacturer and distributor of medical equipment for treating, diagnosing and managing sleep-disordered breathing and other respiratory disorders, announced that it has acquired BiancaMed Ltd., a leading Irish medical technology company. ResMed purchased all of BiancaMed's outstanding shares with cash.

BiancaMed has developed and is marketing an innovative, convenient, non-contact device to monitor sleep and breathing in the home and hospital. BiancaMed's SleepMinder(TM) is an accurate, touch-free device that measures sleep and breathing with sophisticated biometric software. The core of BiancaMed's proprietary technology is a motion sensor that can detect respiration and movement without physical contact with the human body. The company is developing a number of other applications for the technology, across a range of medical and consumer settings.

BiancaMed will become a part of ResMed's newly-created Ventures and Initiatives unit. ResMed estimates the acquisition will dilute ResMed's earnings per share by approximately $0.04 in fiscal year 2012, excluding amortization of intangibles and one-time acquisition related costs... ResMed's Press Release - [PDF] BiancaMed's Press Release -

DeVilbiss Healthcare : Clinical Trial Confirming the Effectiveness of SmartFlex™ Technology

2011-07-12T14:23:00.000-07:00

July 5, 2011 – DeVilbiss Healthcare recently sponsored a randomized, double-blind, crossover clinical study which confirmed the effectiveness of DeVilbiss SmartFlex Technology, a new exhalation pressure relief solution to enhance patient comfort.

Positive Airway Pressure (PAP) represents the gold standard in the treatment of Obstructive Sleep Apnea (OSA). In recent years, pressure modification has become accepted as an important feature improving patients’ comfort and compliance. However, there has been some speculation that excessive pressure relief may compromise the effectiveness of therapy.

The study confirmed SmartFlex Technology to be equally effective to standard Auto-PAP therapy in that respiratory events and oxygen saturation during sleep were normalized among the participants. In addition, treatment with SmartFlex showed a lower leak rate, which likely contributes to the greater subject acceptance rates. As expected, both modalities resulted in improved daytime alertness, but improved daytime energy levels, ability to relax and nocturnal sleep were also demonstrated with SmartFlex Technology... DeVilbiss Healthcare's Press Release -

Acurest : Custom CPAP Mask Now Available for Sleep Apnea Sufferers in the U.S.

2011-07-05T14:37:00.000-07:00

May 31, 2011 - Acurest, the world's only provider of custom-made Continuous Positive Airway Pressure (CPAP) nasal masks for the treatment of sleep apnea disorder, announced that the solution is now available to sleep apnea sufferers in the U.S. Made specifically for each individual from the mold of the patient's face, Acurest's TrueFIT™ Custom Mask features hypo-allergenic materials which will not produce skin reactions, is leak free and fits comfortably, allowing for ease of movement during sleep. The new mask lasts three times longer than off-the-shelf masks.
For Robert Couch, a sleep apnea sufferer who resides in Irving, Texas, purchasing the TrueFIT™ Custom Mask from Acurest proved life-altering.
"I was deep into my stages of sleep apnea and was resigned that I would have to undergo multiple intrusive surgeries that were not guaranteed to work," said Couch. "I continued to purchase uncomfortable, leaking masks which forced my wife to sleep in another room so she could get rest at night. The first morning after using the mask, I woke up refreshed and for the first time in years, felt like I finally knew what a good night's sleep was."... Acurest's Press Release -

Anacor Pharmaceuticals Partnership Advances Novel Drug Candidate to Combat Sleeping Sickness

2011-06-29T14:34:00.000-07:00

June 28, 2011 - PLoS Journal article highlights initial research success of a boron-based compound, ready to enter into clinical development, resulting from collaboration between Anacor Pharmaceuticals, DNDi, and SCYNEXIS - Anacor Pharmaceuticals (NASDAQ:ANAC), the Drugs for Neglected Diseases initiative (DNDi), and SCYNEXIS Inc. announced the successful completion of pre-clinical studies for the first new oral drug candidate discovered specifically to combat human African trypanosomiasis (HAT), also known as sleeping sickness. An article released in the open-access journal PLoS Neglected Tropical Diseases, reveals the initial successful results of pre-clinical studies of the new compound, which will soon advance to Phase I human clinical trials.

Sleeping sickness, which threatens millions in 36 countries in sub-Saharan Africa, is fatal if left untreated. The disease is caused by parasites transmitted by the bite of a tsetse fly and is often asymptomatic for years until the infection reaches "stage 2" where it crosses into the central nervous system and brain. Without effective treatment, sleeping sickness is fatal. Currently available treatments are limited to drugs developed decades ago that are either highly toxic, difficult to administer in resource-limited settings, or are only effective in one stage of the disease. In addition, prior to being treated, the stage of the disease must be determined using a diagnostic spinal tap to extract cerebrospinal fluid from the patient.

Two-thirds of all reported sleeping sickness cases are found in the Democratic Republic of the Congo (DRC), where healthcare is often inaccessible to large parts of the population due to violent conflict, great distances patients must travel to health facilities, and extreme poverty. Dr. Miaka Mia Bilenge, special advisor to the National Control Program for Human African Trypanosomiasis in the DRC, explained that if the new drug candidate proves to be successful, it could become a major weapon to control sleeping sickness.
"People in the DRC and many countries in Africa have hoped for a safe, easy-to-use, and effective treatment against sleeping sickness for generations," Dr. Miaka Mia Bilenge said. "We very much look forward to the start of human trials, and we hope that at long last this will give us a tool for sustainable elimination of this dreaded disease."

In pre-clinical studies, the new drug candidate, SCYX-7158, also registered as AN5568, demonstrated safety and the ability to cross the blood-brain barrier making it efficacious against stage 1 and stage 2 of the disease. In addition, its oral formulation, short duration of therapy and excellent pre-clinical safety profile imply that SCYX-7158 (AN5568) could change the way sleeping sickness is treated, reduce its incidence in humans, and contribute to elimination of the disease... Anacor Pharmaceuticals' Press Release - SCYNEXIS' Press Release -

SeptRx begins CE Mark trial of the SeptRx® Intrapocket PFO Occluder (IPO)

2011-06-23T14:09:00.000-07:00

June 16, 2011—SeptRx, an emerging medical device company that is developing the SeptRx® Intrapocket PFO Occluder (IPO)—a platform for the percutaneous transcatheter closure of a heart defect known as patent foramen ovale (PFO)—announced that the first implants have been completed in the InterSEPT™ clinical trial at the CardioVascular Center at Sankt Katharinen Hospital, Frankfurt, under principal investigator Horst E. Sievert, M.D.
InterSEPT™ (In-tunnel SeptRx European PFO Trial) is a prospective, multi-center, single-arm safety and efficacy trial of the SeptRx® IPO. Data from InterSEPT™ will be used to apply for CE marking. The SeptRx® Intrapocket PFO Occluder has already completed a successful 11-patient first-in-human (FIH) clinical trial. SeptRx’s FIH trial was the first and only PFO device trial to demonstrate 100% closure and 100% safety (out to 3 years)...

[...]

...PFO is a tunnel-like defect connecting the right atrium with the left atrium. A remnant of fetal circulation, it usually seals itself within a few months after birth. Unfortunately, in about 25% of the population the PFO does not fully close and may allow blood (and emboli) to pass directly between the right and left atria. The presence of a PFO has been identified as a contributing factor in cryptogenic stroke, chronic migraine, decompression sickness, and obstructive sleep apnea. A PFO contributes to these conditions by providing a pathway for emboli (blood clots, air bubbles) in the venous system to reach the arterial system by passing directly from the right atrium to the left... [PDF] SeptRx' s Press Release -

DynaFlex : FDA Clearance for Sleep Aid Devices

2011-06-15T14:26:00.000-07:00

MARCH 9, 2011 - DynaFlex, a manufacturer specializing in orthodontic appliances, has obtained FDA 510(k) clearance (K103076) from the US Food and Drug Administration for its DynaFlex® Anti-Snoring & Sleep Apnea Devices line of sleep aid products. Designed to treat snoring and sleep apnea, the DynaFlex products function by repositioning patients’ lower jaws to improve breathing ability during sleep. The devices are available in four model types, and are custom-fitted for each patient based on jaw measurements taken by prescribing health care providers.

The company undertook its FDA 510(k) clearance process in early 2010 with the assistance of Emergo Group, a medical device regulatory and quality assurance consultancy. Emergo Group provided an initial analysis of DynaFlex® Anti-Snoring & Sleep Apnea Devices to determine the most cost-effective and accurate method for submitting DynaFlex’s 510(k) documents, followed by preparation and submission of the 510(k) application to the FDA for review and clearance. Emergo Group also assisted DynaFlex in assuring compliance with the FDA Quality System Regulation, 21 CFR Part 820... DynaFlex's Press Release -

Somaxon and Paladin : Silenor® EX-US Collaboration

2011-06-08T13:36:00.000-07:00

June 8, 2011 - Somaxon Pharmaceuticals, Inc. (NASDAQ:SOMX) and Paladin Labs Inc. (TSX:PLB) announced that they have entered into an exclusive collaboration under which Paladin will commercialize Silenor® (doxepin) for the treatment of insomnia characterized by difficulty with sleep maintenance in Canada, South America and Africa. According to IMS Canada, the value of the Canadian insomnia market, mainly comprised of zopiclone, exceeded $79 million in 2010 alone and has been growing at a 5 year CAGR of 10%.

Under the terms of the agreements, Somaxon will receive an up-front payment of US$500,000, and Paladin will purchase 2,184,769 shares of Somaxon's common stock for a purchase price of US$5 million. Once Silenor is commercialized in the licensed territories, Somaxon will also be eligible to receive sales-based milestone payments of up to US$128.5 million as well as a tiered double-digit percentage of net sales in the licensed territories. Paladin will be responsible for regulatory submissions for Silenor in the licensed territories and will have the exclusive right to commercialize Silenor in the licensed territories. Governance of the collaboration will occur through a joint committee structure... Somaxon's Press Release - Paladin Labs' Press Release -

ResMed : New iPhone App

2011-05-25T14:31:00.000-07:00

May 24, 2011 - Are you always tired? Examine your risk of sleep apnea with ResMed's Sleep Assessment app for iPhone® or iPod Touch® - ResMed (NYSE: RMD) released the ResMed Sleep Assessment app, a novel new app for iPhone that lets users record themselves during sleep. The app also includes a clinically validated questionnaire that assesses their risk and other helpful features to empower users to discuss their sleep health with their physician.

Excessive tiredness may be due to sleep apnea

Feeling excessively tired or fatigued is often the result of disrupted, unhealthy sleep. Numerous factors can lead to poor quality sleep, some of which have significant negative health effects. One possible cause of fatigue is sleep apnea, a common sleep disorder. People with sleep apnea report feeling like they're living in a fog, and that no matter how much they sleep they still feel exhausted.
Sleep apnea is a serious health condition in which a person stops breathing temporarily during sleep. After several seconds, the brain triggers a wake-up response, causing the person to awaken gasping. These events may happen hundreds of times per night, though the sleeper usually won't remember waking up. Often a spouse or partner will notice that the person snores loudly during sleep.
Sleep apnea affects approximately one in five U.S. adults, although it is estimated that as many as 80% of sleep apnea sufferers are undiagnosed and untreated.(1) A known cause of hypertension, untreated sleep apnea has also been linked with type 2 diabetes, cardiovascular disease, depression and stroke.(2-6) People who have sleep apnea feel chronically fatigued and may experience a variety of other symptoms, such as headaches, difficulty concentrating and irritability, to name just a few. Additionally, the loud snoring of sleep apnea can be disruptive to relationships, wreaking equal havoc on a spouse or partner's quality of sleep...

...ResMed's Sleep Assessment app combines a clinically validated questionnaire that quantifies a person's risk of sleep apnea based on known characteristics with an overnight snore recorder that lets them compare their snoring to the snoring of an actual sleep apnea patient. With the snore recorder feature, the user simply starts the app and sets their device by their bedside before sleep. The device records them throughout the night. Users can play back their recording and compare it to sample recordings from actual sleep apnea patients. They may also refer to their recording and questionnaire results when speaking with a physician about their sleep concerns.
In addition to the snore recorder and questionnaire, ResMed's Sleep Assessment app also includes a Sleep Lab Locator, which helps users find a sleep center in their area. Additionally, the app includes a "Sounds to Sleep By" feature with recordings of soothing sounds to play while drifting off to sleep... ResMed's Press Release -

Cortex Pharmaceuticals : Ampakine CX1739 Improves Respiratory Parameters In Obstructive Sleep Apnea Patients

2011-05-13T15:29:00.000-07:00

February 2, 2011 — Cortex Pharmaceuticals, Inc. (OTCBB (CORX)) announced top-line results from an exploratory clinical study with its AMPAKINE® compound, CX1739 in subjects with sleep apnea. The study enrolled 20 relatively healthy adults with moderate-to-severe obstructive sleep apnea, 16 of which were administered a single oral dose of CX1739 and 4 of which received matching placebo for one night. The objective of the study was to further explore safety and tolerability in the sleep apnea population, as well as to assess putative efficacy of CX1739 on a range of sleep apnea parameters assessed by overnight polysomnography.

The study demonstrated that selected oxygen saturation parameters were statistically improved by one dose of CX1739, but the interpretation of these results was complicated by a reduced sleep time during the night following drug treatment. CX1739 did not reduce the mean apnea/hypopnea index (AHI; frequency of apnea or hypopnea events per hour of sleep). However, in the AHI responder analysis, defined as a greater than 40% reduction in the AHI, three subjects (20%) in the CX1739 treatment group were responders, and there were no responders in the placebo group. Furthermore, CX1739 significantly (p<0.05) reduced the apnea/hypopnea time (AHT; cumulative time of all apneas and hypopneas over the night) between the baseline and the treatment night by an average of 21 min, compared to an increase of 12 min in the placebo group. In the AHT responder analysis, defined as a greater than 40% reduction in the AHT, five subjects (30%) in the drug treatment group were responders, with no AHT responders in the placebo group.

There were also statistically significant improvements in a number of blood oxygenation measurements: mean blood oxygen saturation was increased (p<0.01); minimum blood oxygen saturation was increased (p < 0.001); there was a reduction in the total time that blood oxygen saturation was reduced below 90% (p<0.01); and a reduction of the number of times per hour of sleep time that the blood oxygen saturation went below 90% (p<0.05).

Sleep efficiency, the percent of time asleep while in bed for the eight hour session, was significantly (p<0.001) reduced by about 20% after administration of CX1739, although the level of daytime sleepiness, determined by the Clinical Global Impressions Daytime Vigilance test given the morning following treatment, was unaffected by CX1739... Cortex Pharmaceuticals' Press Release -

Ventus Medical : Publication in Sleep Journal Demonstrates Positive Results of Large Multi-Center Clinical Trial for Provent® Sleep Apnea Therapy

2011-04-20T13:24:00.000-07:00

April 4, 2011 - 19 Center, 250 Patient Study Shows Non-Invasive Provent Therapy Significantly Improves Sleep Apnea with High Patient Compliance – Ventus Medical, Inc. reported positive results from a 19 center clinical trial using its FDA-cleared Provent® Sleep Apnea Therapy device to treat obstructive sleep apnea. Provent Therapy uses the patient’s own breathing to create expiratory positive airway pressure (EPAP) to keep the airway open during sleep. The full results of this three month study were published in the April 2011 issue of the peer-reviewed medical journal SLEEP, an official publication of the American Academy of Sleep Medicine.
“This randomized, sham-controlled study demonstrates that Provent Therapy significantly improves the apnea hypopnea index (AHI), a scale to measure the number of breathing interruptions or stoppages per hour of sleep, as well as subjective sleepiness, as measured by the Epworth Sleepiness Scale (ESS) in patients with obstructive sleep apnea,” said study author Richard B. Berry, M.D., professor of medicine at the University of Florida College of Medicine, medical director of the University of Florida and Shands Sleep Disorders Center, and former president of the American Sleep Medicine Foundation. “Importantly, self-reported patient adherence on Provent Therapy was almost 90 percent.” ... [PDF] Ventus Medical's Press Release -

IntelGenx : Positive Bioequivalence Study with Insomnia Thin Film

2011-04-13T10:04:00.000-07:00

April 6, 2011 - IntelGenx Corp. (TSX VENTURE:IGX) (OTCBB:IGXT) ("IntelGenx") announced the completion of a pilot biostudy indicating that IntelGenx has developed a novel oral film, INT0020, that suggests bioequivalency to a leading branded product for the treatment of insomnia. INT0020 has been developed using IntelGenx' proprietary immediate release "VersaFilm" drug delivery technology.

IntelGenx' President and CEO Dr. Horst Zerbe commented, "We are very pleased to have successfully completed another human study with our thin films. Insomnia is a largely untapped, multi-billion dollar market and our insomnia product is based on one of the leading medications within its class and could represent a very large opportunity for us."

Dr. Zerbe added. "Insomnia is a great example of an indication where convenience and quick onset of action are important for the patient making this an ideal application for our VersaFilm delivery system. We have previously completed successful studies in the areas of migraine, erectile dysfunction, and bipolar disorder. We are extremely pleased to have added a fourth product to our already strong pipeline of pharmaceutical films with positive human pharmacokinetic data."... IntelGenx's Press Release -