FDA Approves Intrarosa for Postmenopausal Women

The FDA has approved Endoceutics’ Intrarosa to treat women who experience moderate to severe pain during sexual intercourse, a symptom of vulvar and vaginal atrophy due to menopause.

The approval is based on two 12-week trials that showed Intrarosa reduced the severity of pain during sex compared to placebo. Safety was established in four 12-week placebo-controlled trials and one year-long, open-label trial of 406 post-menopausal women.