The trial is expected to enroll approximately 100 patients at multiple sites in the US. Patients will be evaluated for a total of nine weeks including a four-week screening phase and a five-week treatment phase. The company anticipates announcing results of the trial in early 2007.
“Premature ejaculation is believed to be the most common form of sexual disorder in men,” stated Dr Glenn Cooper, chairman, president and CEO of Indevus. “With no approved pharmacotherapy for the treatment of premature ejaculation, there is a very significant opportunity for Indevus should pagoclone prove to be efficacious.”
Pagoclone is a novel, non-benzodiazepine, GABA-A selective receptor modulator. It is part of a new chemical class of agents and lacks many of the common benzodiazepine side effects such as sedation and withdrawal.