Apricus Biosciences Confirms Clinical Strategy for Novel Treatment for Symptomatic Secondary Hypogonadism Fispemifene

Apricus Biosciences, Inc.

today reaffirmed its regulatory and clinical strategy for the development of fispemifene in response to the Complete Response Letter issued to Repros Therapeutics Inc. (RPRX) by the Food and Drug Administration (FDA). Apricus is developing fispemifene, a SERM (selective estrogen receptor modulator) for the treatment of sexual dysfunction in men with symptomatic secondary hypogonadism. "Apricus has worked with the FDA to develop our clinical strategy for fispemifene," commented Barbara Troupin, M.D., Chief Medical Officer of Apricus. "For our ongoing Phase 2b study, we developed a protocol that addresses the FDA's suggestions for clearly defining the target patient population, designating clinical benefits which are both important and relevant to the target population, and using symptom-based endpoints aimed at assessing those specific benefits in this population. As a result, we believe we are well-positioned to bring a first-in-class SERM product to the U.S. market." Apricus expects to report results from the Phase 2b fispemifene trial in the first quarter of 2016 and, if successful, will continue to work closely with the