Shionogi Inc. announced that the FDA has approved Osphena (ospemifene) tablets to treat women experiencing moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy due to menopause. Osphena is an estrogen agonist/antagonist with tissue selective effects. Osphena is the first oral treatment alternative to vaginal or oral steroidal estrogens.

The safety and efficacy of Osphena were established in three clinical studies of 1,889 postmenopausal women with symptoms of vulvar and vaginal atrophy. Women were randomized to Osphena or placebo. After 12 weeks of treatment, results from the first two trials showed a statistically significant improvement of dyspareunia in Osphena-treated women compared with women receiving placebo. Results from the third study support Osphena’s long-term safety in treating dyspareunia.

Osphena will be available in 60mg tablets in 100-count bottles.

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