There are two pivotal studies running in parallel, one in North America and one in Europe. Each is a multicenter, randomized, double-blind, placebo-controlled efficacy study recruiting a total of 540 patients across both studies. In the European arm, 333 patients have been recruited by 32 investigational centers in four countries across Europe. Patients are being treated for a 12-week period with an optional five-month open-label phase.
The primary endpoints will be intravaginal ejaculation latency time, 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 developed for the treatment of premature ejaculation, a disorder affecting up to 30% of men in Europe and the US, according to the company.