Ospemifene for vaginal dryness

April 9, 2019 0 By FM

The US FDA has expanded use of ospemifene (Osphena) to include treatment of moderate to severe vaginal dryness due to menopause.

Vaginal dryness and itching are symptoms of vulvar and vaginal atrophy.

Ospemifene is an oestrogen receptor agonist/antagonist with tissue selective effects. It is available in 60 mg tablets which were initially approved in 2013 to treat moderate to severe dyspareunia due to menopause.

The approval has been on the basis of safety and efficacy data from a confirmatory phase 3 randomized, double-blind, placebo-controlled multicentre study evaluating ospemifene in patients with moderate to severe vaginal dryness.

The data showed that treatment with ospemifene led to a statistically significant improvement in self-reported, most bothersome symptom of vaginal dryness as well as a statistically significant increase in the proportion of superficial cells and a corresponding statistically significant decrease in the proportion of parabasal cells on a vaginal smear; mean reduction in vaginal pH between baseline and week 12 was also statistically significant.