The Food and Drug Administration on Monday broadened the use of Addyi, a once‑daily pill that boosts female libido, to include postmenopausal women up to 65 years old.
New FDA Approval
Addyi, marketed by Sprout Pharmaceuticals, was first approved 10 years ago for premenopausal women who report emotional stress due to low sex drive. The Monday announcement expands the drug’s use to older women who have gone through menopause.
Safety Considerations
The drug carries side effects such as dizziness and nausea. A boxed warning cautions that drinking alcohol while taking Addyi can cause dangerously low blood pressure and fainting. If patients have several drinks, the label recommends waiting a few hours before taking the drug, or skipping one dose.
Company Response
Sprout CEO Cindy Eckert said in a statement the approval “reflects a decade of persistent work with the FDA to fundamentally change how women’s sexual health is understood and prioritized.” The company, based in Raleigh, North Carolina, announced the FDA update in a press release Monday.
Background on Hypoactive Sexual Desire Disorder
The medical condition for a troublingly low sexual appetite, called hypoactive sexual desire disorder, has been recognized since the 1990s and is thought to affect a significant portion of American women, according to surveys. Doctors are supposed to rule out a number of other issues, including relationship problems, medical conditions, depression and other mental disorders, before prescribing medication.
The FDA rejected Addyi twice prior to its 2015 approval, citing the drug’s modest effectiveness and worrisome side effects. The approval came after a lobbying campaign by the company and its supporters, Even the Score, which framed the lack of options for female libido as a women’s rights issue.
Key Takeaways
- FDA expands Addyi approval to postmenopausal women up to 65 years old.
- The drug’s side effects include dizziness, nausea, and a boxed warning about alcohol interaction.
- Sprout CEO Cindy Eckert highlights a decade of work to change women’s sexual health priorities.
The expansion marks a significant shift in how female sexual health medications are regulated, following the 2019 approval of a second drug for low female libido that uses a different set of neurological chemicals.
