Apricus To Discontinue Fispemifene In Symptomatic Secondary Hypogonadism

(RTTNews) - Apricus Biosciences, Inc. (APRI) announced top-line results from the Phase 2b proof-of-concept study of fispemifene in men with secondary hypogonadism and sexual dysfunction. The company reported that Fispemifene failed to achieve statistical significance in key clinical benefit endpoints despite increase in Testosterone levels.

The company said, while fispemifene at 450mg demonstrated statistically significant improvements in total, percent free and percent bioavailable testosterone compared to placebo, the magnitude of the increase was not sufficient to achieve statistical significance for either the erectile function primary endpoint or low libido secondary endpoint.

Richard Pascoe, CEO of Apricus, said: "As a consequence of these results, we will discontinue all development of fispemifene in symptomatic secondary hypogonadism, and focus our resources on our other homegrown pipeline assets. Specifically, we will focus on growing ex-U.S. Vitaros revenues, seeking U.S. Vitaros approval in 2017, and advancing RayVa with a Phase 2 clinical development program. We believe that focusing on these higher return assets, along with streamlining the organization and reducing our operating expenses, is in the best interest of shareholders."