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.

UNMET NEED:

• 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.

EFFICACY:

• 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

LABEL