PSD 502 receives CHMP recommendation to treat Premature Ejaculation

Plethora Solutions (a subsidiary of Sciele Pharma, a Shionogi company) announced that it has received a positive opinion from the European Medicines Agency�s (EMA) Committee for Medicinal Products for Human Use (CHMP), recommending European Commission (EC) approval for PSD 502 (known in the Marketing Authorisation Application as �Lidocaine Prilocaine Plethora�) for the treatment of primary Premature Ejaculation in adult men. Plethora anticipates a final decision from the EC shortly, as this usually occurs approximately 60 days after a CHMP recommendation.

PSD 502 is a treatment for Premature Ejaculation, comprising a combination of lidocaine and prilocaine in a spray formulation. Clinical studies have demonstrated that PSD 502 is effective in treating Premature Ejaculation with an acceptable safety profile.In 2011, Shionogi granted to Plethora the rights for the regulatory and commercial development of PSD 502 in Europe and certain other territories.