FDA grants priority review to expanded indication of flibanserin in HSDD

The FDA has granted priority review to a supplemental application seeking an expanded approval of flibanserin (Addyi, 100 mg) to treat hypoactive sexual desire disorder (HSDD) in postmenopausal women, Sprout Pharmaceuticals announced in a news release.¹

Flibanserin was previously approved by the FDA in 2015 to treat HSDD in certain premenopausal women.^2,3 Health Canada has also approved expanded use of the non-hormonal medication in women who have gone through menopause.

Priority review is granted to drugs that “would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications,” according to the FDA.⁴ With this designation, a decision on the application for flibanserin is expected within 6 months, compared with 10 months under standard review.

This news comes off the heels of the FDA’s recent expert panel meeting to discuss removal of the boxed warning label on estrogen products. According to Sprout, the priority review designation similarly “reflects the same urgency and momentum, signaling the agency's commitment to ensuring that women at every life stage receive evidence-based care grounded accurately with the current science and focused on improving their quality of life.”

"This isn't just a regulatory milestone—it's cultural recognition," said Cindy Eckert, founder and CEO of Sprout Pharmaceuticals, in the news release from the company.¹ "Sexual desire is ageless. Access to care should be too. Priority review brings us closer to expanding access and empowering more women with a science-backed, FDA approved solution for their sexual wellness."

The safety and efficacy of flibanserin in postmenopausal women were established in the SNOWDROP and PLUMERIA (NCT01057901) trials.

Prior Approval of Flibanserin

Flibanserin was FDA approved in 2015 for the treatment of low libido in certain premenopausal women based on data from 3 phase 3 trials in premenopausal women across North America. For the studies, patients were randomly assigned to flibanserin once daily at bedtime (n = 1187) or to placebo (n = 1188). The average age of participants was 36 years (range, 19 to 55).

According to the FDA, “In all 3 trials, [flibanserin] resulted in statistically significant improvement compared to placebo in the change from baseline in monthly [satisfying sexual events] at Week 24.”²

Further, findings from study 3 showed a statistically significant improvement in the change from baseline to week 24 in sexual desire using the FSFI Desire Domain with flibanserin vs placebo. The FDA also reported, "The FSFI Desire Domain findings were consistent across all 3 trials, as were the findings for the secondary end point that assessed distress using question 13 of the FSDS-R."

Across all 3 trials, 13% of patients in the flibanserin arms vs 6% of patients in the placebo arms discontinued treatment due to adverse events (AEs). The most common AEs among patients treated with flibanserin were dizziness, somnolence, nausea, fatigue, insomnia, and dry mouth.

Experts recommend waiting at least 2 hours after consuming 1 or 2 standard alcoholic drinks before taking flibanserin to reduce risks.

REFERENCES

1. FDA grants Priority Review for Addyi (flibanserin) paving the way for expanded access to treat low sexual desire in postmenopausal women. News release. Sprout Pharmaceuticals. July 24, 2025. Accessed July 24, 2025. https://www.prnewswire.com/news-releases/fda-grants-priority-review-for-addyi-flibanserin-paving-the-way-for-expanded-access-to-treat-low-sexual-desire-in-postmenopausal-women-302512883.html

2. Flibanserin label. US Food & Drug Administration. Accessed July 24, 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022526lbl.pdf

3. Sprout Pharmaceuticals receives FDA approval of Addyi (flibanserin 100 mg). News release. Sprout Pharmaceuticals. August 18, 2015. Accessed July 24, 2025. https://www.prnewswire.com/news-releases/sprout-pharmaceuticals-receives-fda-approval-of-addyi-flibanserin-100-mg-300130368.html

4. Priority review. US Food & Drug Administration. Accessed July 24, 2025. https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/priority-review