FDA News: Week of November 14, 2016
EndoCeutics Inc. Quebec, CANADA
INDICATION: Steroid indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy (VVA), due to menopause.
- Decline of estrogen during menopause cause condition known as VVA
- Pain during sexual intercourse one of the most frequent symptoms of VVA
- Need for treatment option forrelief of dyspareunia caused by VVA
REG PATHWAY: NDA
- Prasterone, also known as dehydroepiandrosterone (DHEA), included in some dietary supplements
- Efficacy/safety of those products not established for diagnosing, curing, mitigating, treating or preventing disease
MECHANISM OF ACTION: Inactive endogenous steroid that is converted into active androgens and/or estrogens; mechanism of action not fully established.
- Four 12-week placebo-controlled trials and one 52-week open-label trial; INTRAROSA vs. placebo
- 4 co-primary endpoints: most bothersome moderate to severe symptom of dyspareunia, the percentage of vaginal superficial cells, the percentage of parabasal cells, and vaginal pH
- Overall, reduced severity of pain experienced during sexual intercourse
SAFETY: Most common adverse reactions: vaginal discharge, abnormal Pap smear