FDA Prioritizes Addyi® Review for Treating Low Desire in Postmenopausal Women

Sprout Pharmaceuticals, based in Raleigh, N.C., announced that its supplemental application for Addyi® (flibanserin 100mg) has been granted Priority Review by the U.S. Food and Drug Administration (FDA). This development may result in expanding Addyi's use to also include women who have gone through menopause. Addyi is currently the only FDA-approved medication designed to address low sexual desire in women.

Addyi is already the leading prescribed treatment for Hypoactive Sexual Desire Disorder (HSDD), a condition affecting millions of women. This advancement reflects a significant step in women's sexual health by potentially addressing their needs across different life stages. It is estimated that nearly 40% of women experience low sexual desire during their lives, yet there are no FDA-approved treatments for women beyond their reproductive years.

Cindy Eckert, the Founder and CEO of Sprout Pharmaceuticals, emphasized the larger implications of this regulatory milestone. She stated that it represents not just an advancement in healthcare, but cultural progress as well. "Sexual desire is ageless. Access to care should be too," Eckert said. The Priority Review status highlights the urgency and significance of filling this treatment gap in women's healthcare.

The FDA reserves Priority Review status for drugs that represent significant improvements over existing treatments for serious conditions. This designation ensures a faster review process and reflects the urgency in addressing unmet medical needs. Sprout Pharmaceuticals aims to expand access to Addyi, thereby providing more women with a scientifically backed, FDA-approved option for their sexual health.

The Priority Review of Addyi comes on the heels of the FDA's recent discussions on the need to modernize outdated estrogen labeling, signaling the Agency's commitment to ensuring that women receive appropriate, science-based care.

Initially approved by the FDA for premenopausal women, Addyi's safety and efficacy have been confirmed by extensive clinical trials in women's sexual health. Health Canada has also approved Addyi for use in postmenopausal women after assessing its robust safety profile. The FDA now has the opportunity to follow suit.

Eckert remarked on the broader impact of this development, noting, "This is about expanding access, expanding awareness, and expanding agency for women who have been overlooked for far too long." If approved, the revised Addyi labeling will mark a significant shift toward inclusive innovation in sexual health, affirming that women deserve options regardless of age.

Sprout Pharmaceuticals is dedicated to advancing the conversation around women's sexual wellness through the introduction of innovative treatments. By launching Addyi, the first FDA-approved pill for low sexual desire, the company has played a pivotal role in shifting perceptions about women's sexual health. Sprout remains committed to scientific progress, broader access, and advocacy for comprehensive women's healthcare.

Addyi, a non-hormonal medication, is prescribed by more than 25,000 healthcare professionals across the U.S. It functions by targeting key neurotransmitters that influence sexual response. Before commencing treatment with Addyi, individuals should discuss their entire medication regimen, including any herbal supplements, with their healthcare provider.

Hypoactive Sexual Desire Disorder (HSDD) is characterized by a chronic lack of sexual interest, affecting roughly 40% of women, according to the Mayo Clinic. It is the most prevalent form of sexual dysfunction among women.

In conclusion, Sprout Pharmaceuticals' pursuit of expanded indications for Addyi could pave the way for more comprehensive, age-inclusive sexual health treatment options for women, addressing a significant unmet need in their healthcare.