Duchesnay announced that the Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Osphena (ospemifene) to expand its use to include treatment of moderate to severe vaginal dryness, a symptom of vulvar and vaginal atrophy, due to menopause.
Osphena is an estrogen receptor agonist/antagonist with tissue selective effects. It was initially approved in 2013 to treat moderate to severe dyspareunia due to menopause.
The expanded approval was based on safety and efficacy data from a confirmatory Phase 3 randomized, double-blind, placebo-controlled multicenter study evaluating Osphena in patients with moderate to severe vaginal dryness. Results from the study showed that treatment with Osphena 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.
“FDA’s approval of this additional indication affirms Osphena’s safety and effectiveness for treating moderate to severe vaginal dryness, broadening its benefits to a larger number of menopausal women,” said Dr James A. Simon, Clinical Professor of Obstetrics and Gynecology at George Washington University.
Osphena is available as 60mg tablets in 90-count bottles.
For more information call (855) 677-4362 or visit Osphena.com.