Boehringer gave up on flibanserin — so-called “Female Viagra” — after the FDA refused to approve it for female sexual arousal disorder, also known as hypoactive sexual desire disorder (HSDD), which is a relatively new diagnosis.
Recall that I blasted the trial data Boehringer submitted to the FDA before the FDA decision (see here). The data from that trial showed that women taking flibanserin experienced 0.8 more “satisfying sex acts” per month than did women taking a placebo. By the way, a “satisfying sex act” can include … wait for it … masturbation!
Now, Sprout Pharmaceuticals is trying to get this drug approved. Sprout claims that a NEW trial of 1,000 patients (Study 511.147) published in the Journal of Sexual Medicine, resulted in “statistically significant improvements in the number of satisfying sexual events (SSEs), as well as increase in sexual desire when compared with placebo.”
I don’t have access to the data, but the description (here) of endpoints sounds very suspicious of data manipulation:
“Study 511.147 was a randomized, placebo-controlled trial in which nearly 1,100 pre-menopausal women with HSDD (mean age: 36.6 years) were treated with flibanserin 100 mg once daily at bedtime or placebo for 24 weeks. Co-primary end points were the change from baseline to study end in number of satisfying sexual events and increases in desire as measured by the Female Sexual Function Index (FSFI) desire domain score. Secondary end points included the change from baseline in FSFI total score, Female Sexual Distress Scale-Revised (FSDS-R) total score, and the FSDS-R Item 13 score, which measures distress associated with low desire on FSDS. Further, clinical meaningfulness of outcomes was assessed using the FDA recommended Patient Global Index of Improvement (PGI-I).”
“All endpoints achieved statistical significance,” claim the authors. It may be statistically significant, but is it SEXUALLY significant?
