Indevus Pharmaceuticals of Lexington, MA has halted research on pagoclone as a treatment for premature ejaculation, citing lack of efficacy data from a Phase II trial. But following a meeting with the FDA, Indevus says it will push ahead with a Phase III trial of pagoclone for stuttering in the first half of next year. Pagoclone is a novel, non-benzodiazepine, GABA-A selective receptor modulator.
"Although the FDA had never considered a drug for stuttering, FDA officials were, in my opinion, extremely well-prepared and were able to give us specific and useful guidance that has allowed us to map out a clear path toward an NDA submission," said Glenn L. Cooper, M.D., president, CEO and chairman of Indevus.
- see the release on pagoclone