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

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

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

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 -