Takeda submits ramelteon
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Takeda is seeking transient and chronic insomnia indications for its novel insomnia agent ramelteon in its Sept. 24 NDA submission. The MT-1/MT-2 melatonin receptor agonist is the first novel mechanism of action for a sleep agent "in 35 years," Takeda says. The firm noted that "in preclinical studies, ramelteon has shown no affinity for GABA or opiate receptors," which are common targets for sleep agents. The clinical program contained over 4,200 patients who received single daily doses for up to a year. Interim data from an ongoing year-long safety study is included in the NDA, as well as animal and human studies evaluating ramelteon's potential for drug dependence and abuse. Results will be presented at the U.S. Psychiatric & Mental Health Congress Nov. 18-21...