FDA expands approval of libido drug Addyi for postmenopausal women
Key Points:
- The FDA has expanded approval of the female libido drug Addyi to include postmenopausal women up to age 65, broadening its use beyond the initial approval for premenopausal women.
- Addyi, approved 10 years ago, faced challenges due to side effects like dizziness and nausea, as well as a boxed warning against alcohol consumption due to risks of low blood pressure and fainting.
- Despite initial hopes for blockbuster sales, Addyi's market performance fell short, and a second drug for female low libido was approved in 2019, offering an alternative mechanism of action.
- The condition treated by Addyi, hypoactive sexual desire disorder, remains controversial with complex diagnosis criteria, as factors like menopause, mental









