Takeda Submitted a New Drug Application for Ramelteon in Japan for Treatment of Insomnia

Takeda Pharmaceutical Company Limited (“Takeda”) today announced its submission of a New Drug Application of ramelteon for treatment of insomnia to the Ministry of Health, Labour and Welfare in Japan.

Ramelteon works by selectively targeting two melatonin receptors in the brain, MT1 and MT2. These receptors are located in suprachiasmatic nucleus, a body’s ‘master clock’, which regulates circadian (24-hour) rhythms, including the sleep-wake cycle. By acting on these receptors, body’s sleep-wake cycle is regulated and physiological sleep is promoted. “The number of patients with insomnia is increasing in Japan, and the necessity of managing insomnia is getting an important issue from the medical, social and economic viewpoints,” said Masaomi Miyamoto, Ph.D., general manager of Pharmaceutical Development Division of Takeda. “Ramelteon has a novel mechanism of action different from currently existing medicines for insomnia. We look forward to offering a new treatment option for insomnia,”

Ramelteon was approved by the U.S. Food and Drug Administration (FDA) in July 2005 as the first and only prescription sleep medication, classified non-controlled substance, showing no evidence of abuse and dependence. It is being marketed by Takeda Pharmaceuticals North America, Inc. under the trade name ROZEREM™. In Europe, Takeda Global Research & Development Center (Europe), Ltd. submitted a marketing authorization application to the European Medicines Agency (EMEA) in March 2007.

Source : www.medadnews.com

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