Fispemifene fails proof of concept trial to treat secondary hypogonadism and sexual dysfunction.-Apricus Biosciences,

Apricus Biosciences, Inc. announced top-line results from the Phase IIb proof-of-concept study of fispemifene in men with secondary hypogonadism and sexual dysfunction. This study was a randomized, double-blind, placebo-controlled study enrolling approximately 160 men to assess safety and tolerability, as well as the ability of fispemifene to improve the sexual function outcomes of erectile function and low libido compared to placebo in men with secondary hypogonadism. While fispemifene at 450mg demonstrated statistically significant improvements in total, percent free and percent bioavailable testosterone compared to placebo (P < 0.0001 at both 4 and 8 weeks), the magnitude of the increase was not sufficient to achieve statistical significance for either the erectile function primary endpoint or low libido secondary endpoint.

Erectile function was assessed using the International Index of Erectile Function erectile function domain (IIEF-EF) questionnaire and Sexual Encounter Profile (SEP) diaries and low libido/desire was assessed using the Psychosexual Daily Questionnaire (PDQ).Fispemifene was generally well-tolerated, and no new or significant safety issues arose from this study. Rates of adverse events were similar between groups with the majority of adverse events being mild or moderate. There were no serious adverse events experienced on fispemifene and there were very few discontinuations. There were no elevations in testosterone above the normal range, and no concerns related to consistent increases in hemoglobin, hematocrit or prostate-specific antigen.

Comment: As a consequence of these results, Apricus Biosciences will discontinue all development of fispemifene in symptomatic secondary hypogonadism.