Osphena Receives New Indication
January 29, 2019 – The U.S. FDA has approved a new indication for Osphena® (ospemifene), manufactured by Duchesnay. It is now indicated to treat moderate to severe vaginal dryness, a symptom of vulvar and vaginal atrophy, due to menopause.
Osphena first received FDA approval in 2013 to treat dyspareunia (painful intercourse) due to menopause. Clinical studies confirmed the safety and efficacy of Osphena for the new indication to treat vaginal dryness. As women age, lower estrogen levels can cause changes in vaginal tissue that may lead to dryness, itching, burning, and painful intercourse. Osphena, a non-hormonal medication, works by increasing the number of superficial cells, decreasing parabasal cells, and reducing vaginal pH.
Recommended dosing is one tablet taken by mouth once per day. A black box warning cautions that Osphena can increase the risk of endometrial cancer for women with a uterus who use an unopposed estrogen. The addition of progestin with estrogen may lower a woman’s risk of endometrial hyperplasia, a condition that may precede endometrial cancer. The black box warning also indicates that women who take Osphena may have an increased risk of stroke or deep vein thrombosis (DVT).