With its second shot at trying to gain FDA approval of its insomnia drug expected to fall short, Transcept Pharma ($TSPT) has some choices to make about how to proceed with development of its lead candidate.
The company's application for approval of Intermezzo--a treatment intended for insomniacs who wake up in the middle of the night and struggle to fall back asleep--appears to be dogged again with safety concerns. Yet company officials, who spoke with FDA staff earlier this week, say they won't have details on the nature of the agency's safety concerns until after they receive an expected complete response letter on or before a PDUFA data of July 14.
Transcept, which is going to provide plans for future development of the treatment later this week, will likely have to show the FDA more safety data. Two years ago, the agency declined to approve the treatment amid concerns about whether the drug would cause people who took the treatment to be impaired while driving after they wake up. The company's latest application included data from a study that showed no impairment four hours after people took the drug got behind the wheel.
Indeed, the FDA has a history of making insomnia med developers jump through additional hoops, often because of the agency's safety concerns. Neurocrine Biosciences ($NBIX) and Somaxon ($SOMX) are just two biotechs that we've seen go back and forth with the agency in pursuit of gaining approval of insomnia drugs. At least Transcept can take some comfort in the story of Somaxon's quest to get FDA approval of sleep med Silenor, which failed to gain the green light from regulators twice before they allowed it onto the U.S. market.