Endoceutics’s Intrarosa Gets Approval from US FDA
The US FDA approved Intrarosa for the treatment of dyspareunia experienced by women who attained menopause. Dyspareunia is moderate to severe pain during sexual intercourse in postmenopausal women. It occurs as a result of decreased levels of estrogen in vaginal tissue leading to vulvar and vaginal atrophy (VVA) that contributes to pain during sexual intercourse.
Intrarosa, a once-daily vaginal insert, contains the active ingredient prasterone, which is also known as dehydroepiandrosterone (DHEA). Nevertheless, the efficacy and safety of dietary products supplemented with DHEA have not been established to diagnose, treat/cure or prevent any disease.
In this study, 406 healthy postmenopausal women aged 40-80 years, suffering dyspareunia as a result of VVA were randomly assigned to receive Intrarosa or a placebo vaginal insert. Two 12-week placebo controlled clinical studies were carried out. It was observed that those who received Intrarosa have experienced less severe pain during sexual intercourse as compared to those with placebo vaginal insert.
Furthermore, to establish the safety of Intrarosa, four 12-week placebo-controlled studies and one 52-week open-label trial was carried out. Vaginal discharge and abnormal Pap smear were found to be the most common side effects of Intrarosa.
Intrarosa is marketed by Canada based private pharmaceutical organization Endoceutics Inc.