Neurocrine Receives Second Approvable Letter for Indiplon

The FDA has sent a second approvable letter to Neurocrine Biosciences indicating that the company’s new drug application (NDA) for indiplon capsules for treating insomnia needs additional clinical and preclinical data.

The first approvable letter, sent in May 2006, requested that the company reanalyze data from certain preclinical and clinical studies, as well as safety data on indiplon capsules.

The requirements listed by the FDA in the second letter, which Neurocrine received Dec. 12, include a clinical trial in elderly patients, a safety study assessing the rates of adverse events while using indiplon compared with a marketed product and a preclinical study to evaluate indiplon use during the third trimester of pregnancy.