Plethora's premature ejaculation inhaler enters Ph III
UK-based Plethora Solutions Holdings has received regulatory approval to start a Phase III study of PSD502 for the treatment of premature ejaculation in Europe, which follows fast on the initiation of a Phase III program for the agent in the USA.
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 USA.
There are currently no approved treatments for premature ejaculation. PSD502 is applied locally on demand and is effective within five minutes. PSD502 has a good safety profile with minimal partner transfer, eliminating the requirement to use a condom. In recently-published results from a Phase II study, the agent was shown to increase ejaculation latency time significantly when compared with placebo, Plethora noted.
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