Transcept Pharmaceuticals said Thursday the Food and Drug Administration wants additional safety data on the developing insomnia drug Intermezzo to consider it for regulatory approval.
The agency is concerned about potential next-day side effects, particularly driving ability. The company is seeking approval of the drug as a treatment for insomnia when a middle of the night awakening is followed by difficulty returning to sleep. The FDA indicated in its letter that safety for the dosing strategy for the intended use has not been established.
Also, the FDA expressed concerns over the potential for patients to take incorrect doses of the drug. The company will likely have to conduct an additional safety study to meet the FDA's request.
Transcept said it will request a meeting with the agency to discuss specific requirements.