Sprout Pharmaceuticals announced that the FDA has granted Priority Review for its supplemental application to expand the indication of Addyi® (flibanserin 100mg), the first and only FDA-approved pill for low sexual desire in women, to also include women who have gone through menopause.
"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."
The FDA's Priority Review designation is reserved for drugs that offer significant improvements in treatment for serious unmet medical needs. With enhanced focus and tighter timelines granted by the Agency, this designation underscores the urgency and importance of closing the gap in women's sexual healthcare.
Following the FDA's recent public meeting on removing outdated estrogen labeling, Addyi's Priority Review reflects the same urgency and momentum signaling the Agency's commitment to ensuring that women at every life stage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.
Backed by the largest clinical trials in women's sexual health, Addyi originally received FDA approval for premenopausal women. After reviewing its robust safety and efficacy profile, Health Canada also approved Addyi with expanded use in women that have gone through menopause. Now the FDA has the data to potentially do the same.
"This is about expanding access, expanding awareness, and expanding agency for women who have been overlooked for far too long," Eckert added.
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