June 20, 2006
Neurocrine says Indiplon may need more testing
The company developing Indiplon says federal regulators may require additional clinical tests before approving the experimental insomnia drug.
Last month Neurocrine Biosciences and Pfizer received an approvable letter on the 5 mg. and 10-mg. doses of indiplon but a rejection letter on the 15-mg. strength.
After reviewing the letters, Neurocrine said the FDA “may require” additional clinical trials on the lower doses and “will likely” require additional clinical data on the higher dose.