Indevus halts research on pagoclone for PE

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

Suggested Articles

Novartis is forging ahead with the development of spartalizumab in "many, many other indications" despite the setback.

Chi-Med has detailed plans to seek approval from the FDA later this year in part on the strength of data from Chinese phase 3 trial.

The clamor for more transparency from the leading pandemic vaccine contenders has been getting louder.