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.
If approved, the expanded indication would extend treatment access to a broader population for whom no FDA-approved pharmacologic option currently exists. This 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.
Clinical Significance and Unmet Need
It is estimated that close to 40% of women will experience low sexual desire at some point in their lives, according to Sprout Pharmaceuticals. Women beyond childbearing years currently have no FDA-approved pharmacologic treatment option for this condition.
"This isn't just a regulatory milestone — it's cultural recognition," said Cindy Eckert, founder and CEO of Sprout Pharmaceuticals. "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."
Mechanism of Action and Clinical Evidence
Flibanserin acts centrally on the primary neurotransmitters that affect sexual response, including serotonin, dopamine, and norepinephrine. The company cited its robust clinical trial data as the foundation for seeking expansion of the label, noting that the drug has already been approved by Health Canada for use in postmenopausal women based on the same evidence.
"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."
Over 25,000 health care professionals in the United States have prescribed flibanserin to treat HSDD in their patients since its original approval.
Original Approval and Safety Profile
Flibanserin received FDA approval in August 2015 for acquired, generalized HSDD in premenopausal women. 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. In 2019, the FDA updated the product labeling to reflect new safety data permitting alcohol consumption with timing restrictions.
The original approval was supported by 3 randomized controlled trials demonstrating modest but statistically significant improvements in sexual desire and reduced distress. Across trials, women experienced approximately 0.5 to 1 additional satisfying sexual event per month compared to placebo.
Safety Considerations
Current risks associated with flibanserin include severe low blood pressure and fainting among women who drink alcohol close to the time of dosage, take certain medications with flibanserin, or have liver problems. Experts recommend waiting at least 2 hours after drinking 1 or 2 standard alcoholic drinks before taking flibanserin to reduce risks.
Common adverse effects include dizziness, somnolence, nausea, fatigue, difficulty falling asleep or staying asleep, and dry mouth. Postmarketing surveillance has not revealed unexpected safety signals. Drowsiness has been noted as a common and potentially serious side effect of flibanserin.
Regulatory Timeline
The FDA's decision on the sNDA is expected later this year, according to Sprout Pharmaceuticals. "This is about expanding access, expanding awareness, and expanding agency for women who have been overlooked for far too long," Eckert added.
