Takeda Receives Approval from the Food and Drug Administration for ROZEREM™ (ramelteon)[ ... Read the full press release ... ]
Osaka, Japan, July 23, 2005 - 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.
Anthony H. Risser | neuroscience | neuropsychology | brain