EISAI : JAPANESE CLINICAL TRIALS CONFIRM SAFETY AND EFFICACY OF INSOMNIA TREATMENT SEP-190

September 15, 2010 - EISAI PLANS TO SUBMIT MAA IN FISCAL 2010 - Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito, “Eisai”) announced that clinical studies conducted in Japanese patients with insomnia have confirmed the efficacy and favorable safety profile of SEP-190 (generic name: eszopiclone). Based on these results, Eisai plans to submit a marketing authorization application in fiscal 2010 seeking approval of the agent to the Japan’s Ministry of Health, Labour and Welfare.

A Phase II/III clinical study (Study 126) with SEP-190 was conducted in Japan in patients with primary insomnia, in addition to a Phase III study (Study 150) in patients with insomnia. Study 126 evaluated the efficacy of SEP-190 in 72 adult patients with primary insomnia through an overnight polysomnography (PSG) and subjective evaluation. Results showed that, compared with placebo, SEP-190 statistically significantly reduced latency to persistent sleep (LPS), as measured by a PSG, and sleep latency (SL), as measured by subjective evaluation, the study’s two primary outcome measures. Study 150 evaluated the long term safety of SEP-190 in 325 adult and elderly patients with chronic insomnia caused by a variety of factors. Results of the study confirmed that the agent has a favorable safety profile.
SEP-190 is a non-benzodiazepine type GABAA agonist (non-benzodiazepine sedative hypnotic) discovered and developed by Sepracor Inc.,... Eisai's Press Release -

ResMed : Study Shows its New CPAP Device Increases Patient Compliance

Sept 16, 2010 - Clinical study confirms new features of S9 Series prolong patients' sleep by up to 30 minutes - ResMed (NYSE: RMD), a leading developer, manufacturer, and distributor of sleep and respiratory medical equipment announced the results of a clinical study confirming that patients' compliance with sleep therapy increases when using ResMed's new CPAP device.
The clinical study of 50 patients suffering from sleep apnoea showed an improvement of 30 minutes in average daily usage, from a mean of 6 hours 35 minutes on the patient's usual CPAP device, to 7 hours 5 minutes, when using the new S9 Series.
Sleep apnoea is one of the more common, and yet highly undiagnosed, sleep disorders. Obstructive sleep apnoea (OSA) is the most common type of sleep apnoea and is marked by the collapse or obstruction of the airway during sleep. The most effective treatment is Continuous Positive Airway Pressure (CPAP) therapy. In this non-invasive treatment, air is pressurised by a small device and delivered to the airway of the patient through a mask that fits on/over the nose, or nose and mouth. The pressurised air keeps the upper airway open and helps the person to get a restful night without interruptions caused by apnoeas... ResMed's Press Release -

SOMAXON PHARMACEUTICALS : SILENOR® CO-PROMOTION AGREEMENT WITH PROCTER & GAMBLE

August 25, 2010 − Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX) announced that Somaxon and Procter & Gamble (NYSE: PG) have entered into a co-promotion agreement for Silenor® (doxepin), a newly-approved treatment for insomnia characterized by difficulty with sleep maintenance.
Under the terms of the agreement, Somaxon and Procter & Gamble will co-promote Silenor with a combined 215 sales representatives in the U.S. market. Procter & Gamble’s professional health care sales force will promote Silenor to targeted primary care and other high-prescribing physicians.

Somaxon’s focus will be on specialists and other top-decile physicians who treat insomnia. In addition, Procter & Gamble will promote Silenor to targeted pharmacies and will provide supplemental managed care support services for Silenor. Somaxon has also granted Procter & Gamble a right of first negotiation relating to rights to develop and market Silenor as an over-the-counter medication in the U.S... [PDF] Somaxon Pharmaceuticals' Press Release -

Cardiac Concepts : First Patients in Pilot Trial in Europe for the RespiCardia System

July 7, 2010 - Trial Underway for the First Implantable System to Treat Heart Failure Patients with Central Sleep Apnea - Cardiac Concepts, Inc., a developer of medical devices to treat Heart Failure patients who experience breathing disturbances during sleep, announced enrollment of the first European patients in a Pilot Clinical Trial. The purpose of the Pilot Study is to understand the respiratory and cardiac benefits of the RespiCardia™ System when treating a breathing disorder known as Central Sleep Apnea (CSA) in Heart Failure patients. Prof. Piotr Ponikowski, Principal Investigator of the Pilot Clinical Trial at The Medical University/4th Military Hospital in Wroclaw, Poland, commented that the system was successfully implanted in 2 male patients, ages 57 and 68 years with ischemic cardiomyopathy and symptoms of moderate heart failure. Despite optimal medical management, both experienced severe sleep breathing disorders. The trial is a 40 patient study being conducted in a number of centers worldwide. Implants are expected to begin in the United States in the coming months.
The RespiCardia System is an implantable device using small, electrical pulses designed to restore more natural breathing patterns in patients with sleep disordered breathing. This respiratory management therapy may also improve Heart Failure and patients’ quality of life. The RespiCardia system is the first implantable device to treat Central Sleep Apnea... [PDF] Cardiac Concepts' Press Release -

Jazz Pharmaceuticals : Update on FDA Advisory Committee Meeting For JZP-6 (Sodium Oxybate) in Fibromyalgia

Aug 20, 2010 - Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) announced that the Joint Advisory Committee of the U.S. Food and Drug Administration (FDA), including the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee, voted 20-2 that the benefit/risk balance did not support the approval of JZP-6 for the treatment of fibromyalgia with the currently proposed Risk Evaluation Mitigation Strategy (REMS).

"While we are disappointed with the recommendation of the Joint Advisory Committee, we plan to work closely with FDA on the continuing review of our new drug application (NDA)," said Bruce Cozadd, Chairman and CEO of Jazz Pharmaceuticals, Inc. "We will carefully consider the input of the Committee as we seek to address the needs of fibromyalgia patients for new treatment options in a safe and responsible way."... Jazz Pharmaceuticals' Press Release -