Reviving The Premature Ejaculation Field; Sciele/Plethora Start Final Phase III
This article was originally published in The Pink Sheet Daily
Executive Summary
Recent approval of Johnson & Johnson’s dapoxetine in Sweden and Finland put field back on the radar.
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The pharmaceutical industry is having another go at developing drugs for premature ejaculation. After several years of dormancy, the lifestyle market successor to erectile dysfunction has signs of life once again, with the recent approval of the pioneer dapoxetine in some Scandinavian markets and the start of the last leg of development for another compound from Sciele and Plethora. Johnson & Johnson subsidiary Janssen-Cilag won the first approval for Priligy (dapoxetine) in Sweden and Finland Feb. 10, for "on-demand" treatment of premature ejaculation in men 18-64 years of age. The company has filed for clearance in a number of other countries globally. In the U.S., excitement is building for Sciele and Plethora Solutions' PSD502, a proprietary aerosolized formulation of two already marketed topical anesthetics - lidocaine and prilocaine. The companies announced Feb. 18 that the final Phase III trial, set in North America, had completed recruitment of roughly 240 patients. Preliminary results are due mid-year. That puts Sciele, a subsidiary of Shionogi, and the urology specialty firm Plethora on track to file an NDA for PSD502 later this year, based on the North American trial and a parallel Phase III trial set in Europe. If all goes well, Plethora Chief Science Officer Mike Wyllie predicts PSD502 will launch in 2010. Data from the already completed 300-patient European trial showed PSD502 met all co-primary endpoints - intravaginal ejaculation latency time and index of premature ejaculation (sexual satisfaction and ejaculatory control) -and all secondary endpoints, including sexual quality of life and partner satisfaction (all p<0.0001). PSD502 is unlikely to face competition from dapoxetine in the U.S. any time soon. FDA issued a "not approvable" letter for the trailblazing J&J drug in 2005 (1 (Also see "Dapoxetine Delay: J&J’s Premature Ejaculation Drug “Not Approvable” At FDA" - Pink Sheet, 26 Oct, 2005.)). While the company has not discussed the details of the "not approvable" letter, J&J did say the conversation focused on the safety profile, a critical issue for any lifestyle drug. The company quickly followed the FDA decision with a publication showing no issues with suicidality for the short-acting selective serotonin reuptake inhibitor, a major concern with other drugs in the class (2 (Also see "J&J’s Dapoxetine Has Sound Safety Profile, But Will FDA Be Satisfied?" - Pink Sheet, 11 Sep, 2006.), p. 18). J&J licensed dapoxetine from PPD-GenuPro in 2001, with exclusive worldwide rights to develop and commercialize the drug for urogenital therapies, including premature ejaculation. Dapoxetine is still listed on the J&J pipeline, with the status of the "not approvable" decision. It has only been mentioned once in company SEC filings since 2005 (announcing the filing in Europe in 2007). J&J initially said it believed that dapoxetine provides benefits for patients and planned to address questions raised in the letter, but it is unclear whether that has happened. According to Elsevier Business Intelligence's drug development database, Inteleos, GlaxoSmithKline also has some early stage projects aimed at premature ejaculation. The firm has two compounds that have completed Phase I trials for the indication: the 5-HT1a antagonist GSK-958108 and GSK-557296. -Becky Jungbauer ([email protected]) |