Plethora stock jumps 55% on study results

UK biotechnology firm Plethora Solutions' stock jumped 55% to 24 pence the on news that a European Phase III study of its PSD502 (lidocaine/prilocaine) aerosol spray for the treatment of premature ejaculation met all three co-primary endpoints.

Initial analyses of the 300-patient, multicenter, randomized, double-blind, placebo-controlled efficacy study show that PSD502, licensed from Japanese firm Shionogi's US arm Sciele Pharma, produced a highly clinically- and statistically-significant increase in intravaginal ejaculation latency time to four minutes compared to one minute with placebo (p<0.0001). The pivotal Phase III trial is running in parallel to a US study with identical protocols, expected to be completed in the first half of 2009. Data from the two studies will be combined for a submission for regulatory approval in both regions. Premature ejaculation affects 25% to 30% of men in Europe and the USA.