Thanks for posting the links, I agree- the data is not good and that was clear from the moment B-I presented it last fall. Still reading, but looks like they pulled every little trick they could to advantage the data in their favor and FDA objects at every turn.
"75% of placebo arm completed study vs only 64-69% in treated arm"- 15% vs 6.8% of discontinuations were due to adverse events
One of two co-primary endpoints failed in both primary efficacy trials. B-I is hanging their hat on a secondary endpoint analysis that the FDA says should not have been conducted because one of the primary endpoints failed and is therefore purely hypothesis-generating.
"Although many of the differences in response rates are statistically significant, the overall response rate (about 30-40% in the flibanserin arm is not compelling, particularly when contrasted with the placebo response rates of about 15-30%."
Efficacy summary:
At issue and a major concern of the Division are the following findings:
1. The trials did not show a statistically significant difference for the co-primary endpoint, the eDiary sexual desire score.
2. The Applicant’s request to use the FSFI desire items as the alternative instrument to evaluate the co-primary endpoint of sexual desire is not statistically justified and, in fact, was not supported by exploratory data from Study 511.77, which also failed to demonstrate a statistically significant treatment benefit on desire using the FSFI desire items.
3. The responder rates on the important efficacy endpoints for the flibanserin-treated subjects, intended to demonstrate the clinical meaningfulness, are only 3-15% greater than those in the placebo arm.
4. There were many significant medical and medication exclusion criteria for the efficacy trials, so it is not clear whether the safety and efficacy data from these trials are generalizable to the target population for the drug.
Though the FDA was charitable enough to grant that flibanserin was not to blame for the woman who died in a plane crash.
