Pharmaceuticals Search Engine [selected websites]

Saturday, July 25, 2009

Cortex : Clinical Study in Sleep Apnea With Its AMPAKINE CX1739

Cortex PharmaceuticalsJanuary 27, 2009 — Cortex Pharmaceuticals, Inc. (NYSE Alternext US (COR)) announced that the UK’s Medicines and Healthcare product Regulatory Agency (MHRA) gave it permission to proceed with the clinical development of CX1739 in subjects with moderate to severe sleep apnea. The study will be conducted in a UK sleep unit using a double-blind, placebo-controlled design in 20 subjects.

Sleep apnea is a chronic disorder characterized by pauses in breathing during sleep, with the most common type being obstructive sleep apnea. Each episode, called an apnea, lasts long enough so that one or more breaths are missed. Such episodes occur repeatedly throughout sleep and may result in significantly reduced blood oxygenation. If left untreated, sleep apnea can lead to an increased risk of stroke, heart attacks, hypertension, obesity and Type II, maturity onset diabetes, as well as an increased risk of accidents due to excessive sleepiness. The National Institute of Health estimates that over 12 million American adults have sleep apnea. There is currently no drug treatment option available for sleep apnea and the market is considered a multi-billion dollar opportunity in North America alone...

...Data obtained from animal studies have demonstrated that AMPAKINE compounds can specifically stimulate breathing by activating regions in the brain stem. In 2008, Cortex announced positive results of two clinical studies that demonstrated the AMPAKINE CX717 could prevent the depression of breathing induced by an opioid analgesic. Further analyses of these clinical studies also showed that CX717 reduced both the number and duration of apnea events caused by the opioid. Studies in animals suggest that CX1739 is approximately three times better than CX717 at reversing breathing depressed by opioids. CX1739 also stimulates another brain region that regulates muscle tone in the upper airways... Cortex Pharmaceuticals' Press Release -

Saturday, July 18, 2009

Mylan : FDA Approval for Additional Strength of Generic Restoril®

Mylan PharmaceuticalsJune 17 , 2009 - Mylan Inc. (NASDAQ: MYL) announced that its subsidiary Mylan Pharmaceuticals Inc. has received approval from the U.S. Food and Drug Administration (FDA) for its supplemental Abbreviated New Drug Application (ANDA) for Temazepam Capsules USP, 22.5 mg. This strength is in addition to Mylan's currently marketed 15 mg and 30 mg strengths of the product.

Temazepam Capsules are the generic version of Mallinckrodt's Restoril®, a sleep aid, which had total U.S. sales of approximately $6 million for the 12 months ending March 31, according to IMS Health. Mylan has begun shipping this product...

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Mylan Inc., which provides products to customers in more than 140 countries and territories, ranks among the leading diversified generics and specialty pharmaceutical companies in the world. The company maintains one of the industry's broadest - and highest quality - product portfolios, supported by a robust product pipeline; owns a controlling interest in the world's third largest active pharmaceutical ingredient manufacturer; and operates a specialty business focused on respiratory and allergy therapies... Mylan's Press Release -

Neurim Pharmaceuticals : Long Term Efficacy and Safety for Circadin(R) for Insomnia in Elderly Patients

Neurim PharmaceuticalsJune 11, 2009 - Neurim Pharmaceuticals presented the preliminary results of a large-scale Phase III study of Circadin(R) 2mg, prolonged release melatonin in insomnia, demonstrating long term efficacy and safety in elderly patients. The results were reported in the Late Breaking Abstracts session of SLEEP 2009, the 23rd Annual Meeting of the Associated Professional Sleep Societies, (APSS) held at Seattle, Washington. The SLEEP meeting attracts the largest audience of sleep specialists in world.

Circadin(R) is a novel sleep medicine that has been approved by the European Commission pharmaceutical regulatory agency and the Israeli Ministry of Health for the short-term treatment of primary insomnia, characterized by poor quality of sleep in patients who are aged 55 and over. The approval is based on clinical studies showing positive effects on sleep quality, sleep induction, and most importantly next day alertness and functioning...

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About Neurim Pharmaceuticals

Neurim Pharmaceuticals is headquartered in Israel with offices in Switzerland and the UK. The company was founded in 1991 and is focused on drug discovery and development of treatments for age-related disorders, primarily in the central nervous system (CNS)... Neurim Pharmaceuticals' Press Release -

Kai Sensors : Contract for Wireless Sleep Monitor

Kai SensorsJune 14, 2009 -- Kai Sensors, an award winning developer of wireless, noncontact vital signs monitoring products, including the recently FDA cleared Kai RSpot, has won a National Science Foundation (NSF) SBIR Phase I contract to develop an innovative wireless sleep monitoring system for detecting sleep apnea and other sleep disorders.
Sleep is widely understood to play a key role in physical and mental health. Yet research indicates that 40 million Americans suffer from insomnia and chronic sleep disorders, with over 12 million Americans suffering from obstructive sleep apnea OSA). Serious consequences including increased mortality rate can result from untreated sleep disorders. The direct annual cost for OSA in the United States is estimated to be $16 billion.
Kai Sensors will use the $100,000 NSF SBIR Phase I contract to develop a prototype wireless sleep monitoring system. Upon successful completion of a working prototype in Phase I, Kai Sensors could qualify for a $500,000 Phase II award that would support completion of the device...

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About Kai Sensors, Inc.
Headquartered in Honolulu, Hawaii, Kai Sensors develops products designed to measure and monitor vital signs wirelessly, with no contact, and from a distance. Kai Sensors’ products are designed for use in medical, national security, and other markets... [PDF] Kai Sensors' Press Release -

Ventus Medical : New Data Support Effectiveness of its PROVENT® Therapy In Treating Obstructive Sleep Apnea

Ventus Medical(June 9th, 2009) - Data Presented at SLEEP 2009 Conference - Discreet, Nightly-Use Prescription Device for the Treatment of Obstructive Sleep ApneaVentus Medical, a privately-held medical device company focused on improving the lives of patients with sleep-disordered breathing, announced that clinical data from three poster presentations presented at the SLEEP 2009 23rd Annual Meeting of the Associated Professional Sleep Societies further confirm PROVENT® Sleep Apnea Therapy’s clinical utility in treating mild, moderate and severe obstructive sleep apnea (OSA)...

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About Ventus Medical
Ventus Medical is a medical device company focused on improving the lives of patients with sleep-disordered breathing. Located in Belmont, California, Ventus Medical has developed and markets PROVENT Therapy, an innovative, clinically-proven treatment for OSA. Existing OSA solutions do not always meet patients’ needs. Through truly innovative technology, solid clinical evidence, and a focus on the patient, Ventus Medical seeks to deliver consumer-preferred, physician-recommended solutions. The company is privately-held and funded by De Novo Ventures, Mohr Davidow Ventures, and Johnson & Johnson Development Corporation... [PDF] Ventus Medical's Press Release -