MI, what are your thoughts on the chances for Flib. at the adcom meeting on Thur, here are the materials:
FDA - Briefs
first 7 pages interesting, FDA is concerned about drug intereaction and alcohol use with FLIB, FDA agrees on stat significance but the big question is it worth the risk
fda.gov
Sprout Briefs - fda.gov
the big issue will be drug and alcohol interaction, the driving issue came out positive
DRAFT QUESTIONS Page 1 of 2
1. DISCUSSION: Comment on the clinical significance of the observed placebo-corrected treatment effects of flibanserin on satisfying sexual events, sexual desire, and related distress.
2. DISCUSSION: Take into account the generalizability of the clinical studies to the population of premenopausal women who would likely use flibanserin, if approved.
Then, discuss your level of concern with the risks of hypotension and syncope when flibanserin is used alone and when flibanserin is used with alcohol. Include a discussion of the following:
a. Whether the alcohol interaction study conducted mostly in men who were moderate alcohol drinkers adequately assesses risk in premenopausal women and in those who generally drink less alcohol than moderate drinkers
b. The feasibility of avoiding alcohol indefinitely while using flibanserin, taking into account the prevalence of alcohol use in the United States
c. Whether alcohol use should be contraindicated in patients using flibanserin
d. Whether a risk evaluation and mitigation strategy (REMS) is necessary and would be able to ensure that the benefits outweigh the risks of hypotension and syncope with flibanserin alone and with concomitant use of alcohol
e. If a REMS is appropriate, comment on whether the Applicant’s proposed REMS (consisting of a Medication Guide and communication plan) is sufficient to ensure safe use or whether additional elements such as elements to assure safe use (ETASU) with pharmacy certification or ETASU with pharmacy and provider certification, are needed.
3. DISCUSSION: Take into account the generalizability of the clinical studies to the population of premenopausal women who would likely use flibanserin, if approved. |
