Dive Brief:
- PSD502 is a topical spray that contains lidocaine and prilocaine. It is designed to be used five minutes before intercourse in order to prevent premature ejaculation.
- UK-based Plethora has granted marketing rights to Recordati in a deal that could be worth more than $60 million. Coverage includes Europe, Russia, Turkey, and parts of Northern Africa.
- Phase III studies show that PSD502 significantly increases mean intravaginal ejaculatory latency time.
Dive Insight:
While Recordati will market PSD502 throughout Europe and North Africa, Plethora will retain rights to the product. In phase III trials, PSD502 increased mean intravaginal ejaculatory latency time from 0.5 minutes at baseline to 3.2 minutes by week 12.
Overall, 87% of the men who used PSD502 were considered responders. There were no safety or tolerability issues noted. Other goals for this product include European Medicines Agency approval of a 6-can pack, approval in the U.S., and buying back royalty rights to the spray from Shionogi, Paul Royalty Fund, Holdings Capital, and Richard Henry.