The FDA approved TherapeuticsMD's hormone therapy Imvexxy for a vaginal condition linked to low estrogen levels during menopause, the company announced May 30.
Here are four things to know:
1. Imvexxy is intended to treat moderate-to-severe dyspareunia, or vaginal pain associated with sex. The condition is a symptom of vulvar and vaginal atrophy, which often occurs during menopause when women produce less estrogen.
2. The hormone therapy is administered as a softgel capsule inserted into the vagina and will be available in two doses.
3. Imvexxy contains a black box warning on its label, noting the risk of endometrial and breast cancers, cardiovascular disorders, and probable dementia.
4. TherapeuticsMD plans to conduct a post-approval observational study on the drug's safety per the FDA's request.