FDA approved ROZEREM™ (ramelteon)

07/22/05

First and only non-scheduled prescription sleep medication; new option is the first prescription insomnia medication with a novel therapeutic mechanism of action in 35 years

LINCOLNSHIRE, Ill., July 22 – Takeda Pharmaceuticals North America, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for ROZEREMTM (ramelteon) 8-mg tablets for the treatment of insomnia characterized by difficulty with sleep onset. The FDA approval allows physicians to prescribe ROZEREM for long-term use in adults.

ROZEREM is the first and only prescription sleep medication that has shown no evidence of abuse and dependence and, as a result, has not been designated as a controlled substance by the U.S. Drug Enforcement Administration (DEA). With the exception of ROZEREM, all other prescription medications indicated for insomnia are classified as Schedule IV controlled substances by the DEA. Additionally, ROZEREM is the first prescription insomnia medication with a new therapeutic mechanism of action in 35 years, and will be available for patients by late September.

"People with insomnia are not only affected by their sleeplessness at night; insomnia's impact is also in how they feel and function the next day," said Thomas Roth, Ph.D., director of the Sleep Disorders and Research Center, Detroit, Mich. "Current therapies often used for insomnia work by broadly inhibiting the activity of neurons in the brain. Ramelteon treats insomnia by specifically affecting the activity of neurons in an area of the brain involved in the sleep-wake process, and has been shown to carry no risks of abuse, withdrawal, or dependency, and negligible risk for next-day 'hangover' effects."

"ROZEREM represents an exciting new option in sleep medicine that we anticipate can help millions of people who live with sleepless nights and sluggish days," 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."

ROZEREMTM (ramelteon) has a unique therapeutic mechanism of action that selectively targets two receptors located 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.

The ROZEREM NDA, submitted in September 2004 by Takeda Global Research & Development Center, Inc., was based on data collected from an extensive clinical research program, including recently completed clinical studies with more than 4,200 patients ages 18 to 93. In one study, 472 patients received single daily doses of ROZEREM for up to one year. Also, based on recently presented clinical trials, ROZEREM has been shown to be safe for older adults, as well as those who have mild-to-moderate chronic obstructive pulmonary disease (COPD) and mild-to-moderate sleep apnea.

Source: Eurekalert & others

Last reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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