FDA Grants Fast Track Designation for Sprout's Flibanserin to Treat HSDD in Postmenopausal Women

The FDA has accepted for Priority Review a supplemental new drug application (sNDA) seeking to expand the indication for flibanserin 100 mg to include postmenopausal women with hypoactive sexual desire disorder (HSDD). Flibanserin, marketed as Addyi by Sprout Pharmaceuticals, is currently the only FDA-approved, non-hormonal oral therapy for low sexual desire in premenopausal women.1

If approved, the expanded indication would extend treatment access to a broader population for whom no FDA-approved pharmacologic option currently exists, according to a Sprout statement.1

“This isn't just a regulatory milestone — it's cultural recognition,” Cindy Eckert, founder and CEO of Sprout Pharmaceuticals, said in the statement. “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.”1

Flibanserin acts centrally on the primary neurotransmitters that affect sexual response, including serotonin, dopamine, and norepinephrine. Sprout Pharmaceuticals cited its robust clinical trial data as the foundation for seeking expansion of the label. The company noted that the drug has already been approved by Health Canada for use in postmenopausal women based on the same evidence.1

“Backed by the largest clinical trials in women's sexual health, [flibanserin] originally received FDA approval for premenopausal women. After reviewing its robust safety and efficacy profile, Health Canada also approved [flibanserin] with expanded use in women that have gone through menopause,” according to the company’s announcement. “Now the FDA has the data to potentially do the same.”1

If approved, this change would represent the first FDA-approved pharmacologic therapy for HSDD in postmenopausal women and may help address what advocates describe as a long-standing unmet need. It is estimated that close to 40% of women will experience low sexual desire at some point in their lives, according to the Sprout statement. Women beyond childbearing years have no option for treatment.

“This is about expanding access, expanding awareness, and expanding agency for women who have been overlooked for far too long,” Eckert added.1

Flibanserin received FDA approval in August 2015 for acquired, generalized HSDD in premenopausal women.2 Approval followed an 18–6 advisory committee vote in favor of approval and required a Risk Evaluation and Mitigation Strategy (REMS) to address concerns about hypotension and syncope, particularly with concurrent alcohol use or CYP3A4 inhibitors.2 In 2019, the FDA updated the product labeling to reflect new safety data permitting alcohol consumption with timing restrictions.3

The original approval was supported by 3 randomized controlled trials demonstrating modest but statistically significant improvements in sexual desire and reduced distress.2 Across trials, women experienced approximately 0.5 to 1 additional satisfying sexual event per month compared to placebo. Common adverse effects include dizziness, somnolence, nausea, and fatigue. Postmarketing surveillance has not revealed unexpected safety signals.1,2

The FDA’s decision on the sNDA is expected later this year, according to Sprout.

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 25, 2025. Accessed July 25, 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. Sprout receives FDA approval of ADDYI (flibanserin 100 MG). News release. Sprout Pharmaceuticals. August 19, 2015. Accessed July 224, 2025. https://www.biospace.com/sprout-receives-fda-approval-of-addyi-flibanserin-100-mg

3. Summary of recent regulatory guidance for Addyi, the first and only pill for hypoactive sexual desire disorder. News release. Sprout Pharmaceuticals. September 11, 2019. Accessed July 24, 2025. https://sproutpharmaceuticals.com/september-11-2019