BioSante female libido drug flops in Ph III studies

US biotechnology firm BioSante Pharmaceuticals (Nasdaq: BPAX) saw its shares go into free fall in extended trading, after the company revealed top-line results from its two pivotal Phase III LibiGel (testosterone gel) efficacy trials, joining the list of failures in the search for a “female Viagra.” The stock plunged 76% to $0.50 and saw the stock downgraded by a dozen or so analysts.

Initial analysis of the data from these trials shows that they did not meet the co-primary or secondary endpoints. Although there were no statistical differences in the endpoints, all results were in the appropriate directions. LibiGel is in development for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in postmenopausal women, for which there is no FDA-approved product, the company noted.

Among other notable failures, Germany’s Boehringer Ingelheim abandoned its development of flibanserin last year, after a US Food and Drug Administration panel of advisers voted unanimously that the benefits of flibanserin do not outweigh side effects (The Pharma Letter October 11, 2010). Additionally, Pfizer dropped development of its blockbuster erectile dysfunction drug Viagra (sildenafil) in women in 2004, and Procter & Gamble’s testosterone patch did not get marketing approval.