Premature Ejaculation

Premature ejaculation (PE) is a medically recognised condition defined as “persistent or recurrent ejaculation with minimal sexual stimulation before, upon, or shortly after penetration, and before the person wishes it”.

The exact cause of PE has not yet been clarified, although a number of psychological and biological factors, such as hypersensitivity of the glans penis, contribute to PE.

PE is the most common form of sexual dysfunction in men. Epidemiological studies conducted in the US and in Europe indicate a prevalence of 25 to 30% in men of all ages. The American Medical Association reported that approximately 20 million men in the US experience PE. There is currently no globally approved and effective pharmaceutical treatment for this condition.

In the absence of any approved pharmaceutical therapy, the PE market offers significant potential for development and growth. An effective drug therapy for PE may have a comparable commercial potential to the erectile dysfunction drug, Viagra®, for which current annualized sales are in the region of $1.7 billion.

Plethora has developed PSD502 as a proprietary topical agent for the treatment of PE. Following successful completion of clinical development, global rights to the product were acquired by Sciele Pharma Inc. (now Shionogi Pharma Inc) in May 2009.

The following posters have been published on PSD502 [Please click on the title to view]:

• TEMPE, a novel aerosol delivery form of lidocaine-prilocaine for the treatment of premature ejaculation – presented at ESAU 2006 (307)
• Practical and Effective Treatment of Premature Ejaculation (PE) with a Lidocaine-Prilocaine Spray – presented at AUA 2003 (272)
• A multi-centre, double-blind, randomised, placebo-controlled, parallel-group study to determine the efficacy and safety of PSD502 in patients with premature ejaculation – presented at BAUS 2006 (186)
• TEMPE (Topical Eutectic-Like Mixture for Premature Ejaculation) – presented at CURY 2008 (331)