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 due to menopause.The vaginal dryness and itching are symptoms of vulvar and vaginal atrophy.
Osphena is is an estrogen receptor agonist/antagonist with tissue selective effects. It is available in 60 mg tab which was initially approved in 2013 to treat moderate to severe dyspareunia due to menopause. It works like estrogen in the lining of the uterus, but can work differently in other parts of the body.
The expanded approval has been on the basis of 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.
The study results 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.Taking estrogen alone or Osphena® may increase chance for getting cancer of the lining of the uterus. Vaginal bleeding after menopause may be a warning sign of cancer of the lining of the uterus.
The main contraindications include undiagnosed abnormal genital bleeding, known or suspected estrogen-dependent neoplasia,Active DVT, pulmonary embolism, or history of. Active arterial thromboembolism (eg, stroke, MI, or history of). Known or suspected pregnancy (Cat.X).
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