Takeda's Rozerem sleep aid to debut in September: Insomnia agent Rozerem (ramelteon) will launch in September after receiving FDA approval July 22, Takeda says. Indicated for "treatment of insomnia characterized by difficulty with sleep onset," Rozerem will be marketed by more than 1,000 reps highlighting its melatonin receptor activity and lack of abuse potential, the company says. Rozerem is the first MT-1/MT-2 melotonin agonist approved for insomnia. The leading insomnia therapies - Sanofi-Aventis' Ambien (zolpidem), Sepracor's Lunesta (eszopiclone) and King's Sonata (zaleplon) - target the gamma-aminobutyric acid receptor complex. Takeda notes that Rozerem is unique in that "all other prescription medications indicated for insomnia are classified as Schedule IV controlled substances" by the Drug Enforcement Administration (1Pharmaceutical Approvals Monthly February 2005, p. 10)...

Neurocrine to refile indiplon after meeting with FDA. Agency refuses to file application for the immediate-release formulation of Pfizer/Neurocrine’s insomnia agent due to difficulties with the electronic NDA. Firm also plans to reformat and refile its modified-release NDA to ensure consistency

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...