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

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

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

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

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...

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

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

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 -