SAN DIEGO The Food and Drug Administration has sent a second approvable letter to Neurocrine Biosciences informing the company that its new drug application for indiplon 5 mg and 10 mg capsules is approvable pending additional and preclinical data.
The first letter was received on May 15, 2006. The 2006 approvable letter requested that the company reanalyze data from certain preclinical and clinical studies to support approval of indiplon 5 mg and 10 mg capsules for sleep initiation and middle of the night dosing. The first approvable letter also requested reexamination of the safety analyses.
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. Nothing in the letter asked for the company to look over any issues previously raised by the FDA.