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news.Sciele Pharma and Plethora Solutions have initiated patient enrollment for the Phase III clinical trials in the US for PSD502 for the treatment of premature ejaculation.
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Plethora intends to run the two pivotal studies in parallel, one in the US and one in Europe. Each will be a multi-center, randomized, double-blind, placebo-controlled efficacy study recruiting a total of 540 patients across both studies.
The primary endpoints will be intra-vaginal ejaculation latency time (IVELT), sexual satisfaction and ejaculatory control. Secondary endpoints will include sexual quality of life and partner satisfaction.
PSD502 is a proprietary formulation of two marketed drugs, lidocaine and prilocaine, dispensed by a metered dose aerosol and developed for the treatment of premature ejaculation, a disorder affecting up to 30% of men in Europe and the US.
Steven Powell, CEO of Plethora, said, “We are pleased to be advancing PSD502 into the final stage of clinical development for the treatment of premature ejaculation. If patient recruitment proceeds as planned, we would expect to see headline data towards the end of 2008 which will be a major milestone in the life of both this product and Plethora.”