FDA News: Week of November 14, 2016

FDA approved


Intrarosa

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


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