Flibanserin demonstrates efficacy [sort of] and tolerability in pivotal Phase III Trials in pre-menopausal women with Hypoactive Sexual Desire Disorder (HSDD)
Results support flibanserin as a potential treatment for HSDD, an under-recognised women`s sexual health condition
B-I ran 4 phase 3 trials for this potential BPAX libigel competitior in premenopausal women (BPAX trials currently are in post-menopausal women) and presented 3 abstracts.
The drug is safe.
The north american trial of lower doses is not mentioned, so presumably didn't work.
The european trial failed its primary endpoint.
The 2 north american trials, when pooled, hit the primary endpt of increasing number of satisfying sexual events. When these two are pooled with the european study also, the primary endpt remains stat sig.
The results are much less impressive than libigel phase 2 data- flibanserin resulted in less than one additional SSE per month vs placebo.
Net, this is bullish for BPAX and AIS in my opinion
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