FDA grants Priority Review to flibanserin for treating postmenopausal HSDD

FDA grants Priority Review to flibanserin for treating postmenopausal HSDD | Image Credit: © Araki Illustrations – © Araki Illustrations – stock.adobe.com.

The FDA granted Priority Review to an application for flibanserin 100 mg (Addyi; Sprout Pharmaceuticals), utilized in women with low sexual desire, to expand its use to women who have undergone menopause, according to Sprout Pharmaceuticals on July 24, 2025.¹

Flibanserin is the first and only pill approved by the FDA for the treatment of low sexual desire in women, highlighting a landmark in managing hypoactive sexual desire disorder (HSDD). No other FDA treatments have been approved, despite nearly 40% of women reporting low sexual desire within their lifetimes.

“Sexual desire is ageless. Access to care should be too,” said Cindy Eckert, founder and CEO of Sprout Pharmaceuticals. “Priority Review brings us closer to expanding access and empowering more women with a science-backed, FDA approved solution for their sexual wellness.”

Flibanserin’s clinical reach

Over 25,000 health care professionals in the United States have prescribed flibanserin to treat HSDD in their patients. It is a nonhormonal treatment, influencing key neurotransmitters that play a key role in sexual response.

An original FDA approval for the use of flibanserin in premenopausal women occurred following results from the largest clinical trials in women’s sexual health. Health Canada approved the medication for use in menopausal women as well following a review of its robust safety and efficacy profile.

The FDA now may also approve the use of flibanserin in this population. This would highlight a shift toward life-stage-spanning sexual health innovations, providing women access to multiple treatment options regardless of their age.

Risks of flibanserin

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.

Doctors should also consult with their patients to encourage safety when taking flibanserin, ensuring their patients do not administer the treatment if they have liver problems or take a contraindicating medication. Allergic reactions should also be assessed before prescribing flibanserin.

Alongside these adverse events, drowsiness has been noted as a common and potential serious side effects of flibanserin. Additional side effects include difficulty falling asleep or staying asleep, dizziness, nausea, and dry mouth.

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

Testosterone therapy as an alternative treatment

Prior data has shown variations in duration, route, and co-administration with estrogen patterns when using testosterone therapy (TTh) in women with HSDD.² This method has been recommended for HSDD treatment previously, but unlike flibanserin, it has not received FDA approval.

Data about TTh use in women with HSDD was obtained from patients aged 18 to 70 years using TriNetX Diamond. The final analysis included 33,418 women aged a mean 44.2±10.8 years at HSDD diagnosis.

TTh was given to 850 individuals, 461 of whom were prescribed injectable testosterone, 257 topical testosterone, and 119 pellets. Co-prescription estrogen was reported in 162. Based on this variety, investigators concluded further research about the efficacy and long-term outcomes of this method is needed.

References

1. FDA grants Priority Review for Addyi (flibanserin) paving the way for expanded access to treat low sexual desire in postmenopausal women. 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. Krewson C. Variations found in testosterone therapy for women with HSDD. Contemporary OB/GYN. May 7, 2024. Accessed July 24, 2025.