Plethora reports PSD502 trial success

Plethora Solutions has moved closer to global approval for its PSD502 premature ejaculation treatment for men after a final US phase 3 trial met all of its objectives.This study, involving patients from the US, Canada and Europe, was one of two pivotal Phase III studies for PSD502, which were run in parallel with identical protocols. The previously announced Phase III study was conducted entirely in Europe last year. Data from the two studies will be combined for submission for regulatory approval in the USA and Europe, Plethora said."We are delighted with these highly significant results from the second and final Phase III clinical study which reinforce the results from the European Phase III trial. This represents an important milestone in the regulatory submission process," Dr Mike Wyllie, CSO of Plethora, commented.Sciele Pharma, a subsidiary of Shionogi Corporation, acquired global rights to PSD502 in May.