New drug application to market ramelteon for insomnia

Takeda Global Research & Development Center announced today that it has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) to market ramelteon (TAK-375), its investigational drug for insomnia.

Ramelteon belongs to a new class of prescription drugs with the first novel mechanism of action to be developed in 35 years in the area of sleep research. Ramelteon specifically targets the MT1 and MT2 receptors in the brain, which are believed to be critical in the regulation of the body's sleep-wake cycle.

"The NDA submission for ramelteon is a significant milestone for Takeda," said John Yates, M.D., president of Takeda Global Research & Development. "Since the discovery of the ramelteon compound by Takeda researchers in 1997, our company has been dedicated to exploring its effects in patients who have difficulty sleeping. This submission is the result of the hard work and dedication of our many employees and partner investigators."

The submission is based on data collected from Takeda's extensive clinical research program, including recently completed Phase 3 studies. The clinical research program included more than 4,200 patients, ages 18 to 93, who received single daily doses of ramelteon for various periods of time up to one year. Ramelteon has been studied in clinical trials in the U.S., Japan and Europe. Seven placebo-controlled trials were conducted to determine the efficacy of ramelteon in the treatment of insomnia, and results from 42 ramelteon trials are summarized in the company's safety database. The company's clinical research database also includes interim data from an ongoing, year-long safety study.

In addition, Takeda has conducted animal and human studies to further assess ramelteon's safety attributes. These studies specifically evaluate whether or not treatment with ramelteon has the risk of drug dependence and abuse associated with other FDA-approved drugs for insomnia. Results from the animal abuse liability and addiction studies will be presented at the U.S. Psychiatric and Mental Health Congress later this year.

"We're excited about the continued development of ramelteon. Insomnia is a serious condition that affects the daily lives of millions of Americans, and we believe that there is a significant need for new treatment options that may benefit patients," said Stephen Sainati, M.D., Ph.D., vice president of Clinical Research at Takeda.