FDA approves Rozerem (ramelteon) for insomnia

Main Category: Sleep / Sleep Disorders / Insomnia
Article Date: 26 Jul 2005 - 5:00 PDT

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Takeda Pharmaceutical Company Limited ("Takeda") today announced that its US based global research and development organization, Takeda Global Research & Development Center Inc. has received an approval from the U.S. Food and Drug Administration (FDA) for ROZEREM (ramelteon), 8 mg tablets for the treatment of insomnia. ROZEREM is the first and only prescription sleep medication not designated as a controlled substance by the U.S. Drug Enforcement Administration (DEA). Takeda Pharmaceuticals North America, Inc. will market ROZEREM in the US market.

ROZEREM has a unique therapeutic mechanism of action as compared to existing insomnia treatments because it selectively targets two receptors in the brain's suprachiasmatic nucleus (SCN). The SCN is known as the body's "master clock" because it regulates 24-hour or "circadian" rhythms, including the sleep-wake cycle.

Takeda discovered ramelteon in 1996, and the ROZEREM New Drug Application (NDA), submitted in September 2004, was based on data collected from Takeda's extensive clinical research program, including recently completed clinical studies with more than 4,200 patients.

ROZEREM has been shown to decrease the time to sleep onset in controlled clinical trials with the wide range of patients including older adults, and also to carry minimal risks of rebound insomnia and dependency.

"ROZEREM represents an exciting new option in sleep medicine that we anticipate can help millions of people who live with sleepless nights," said Yasuchika Hasegawa, President and Chief Operating Officer of Takeda. "The approval of ROZEREM marks a major milestone for Takeda as we seek to bring innovative therapies to patients in a variety of therapeutic areas."

About Takeda Pharmaceutical Company Limited

Takeda, located in Osaka, Japan, is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products.

http://www.takeda.co.jp