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Osphena Approved by FDA to Treat Dyspareunia

Osphena Approved by FDA to Treat Dyspareunia

Osphena (ospemifene), an estrogen agonist/antagonist with tissue selective effects, has been approved by the FDA to treat dyspareunia. This is the first non-steroidal estrogen available for women with dyspareunia (painful intercourse), a symptom of vulvar and vaginal atrophy (VVA) that is common during menopause. 

The results of a multicenter, randomized, double-blind, placebo-controlled trial and subsequent safety extension were published online and ahead of print in the journal Menopause. Researchers found that 60 mg of once-daily oral ospemifene was effective in treating of vulvar and vaginal atrophy in postmenopausal women with dyspareunia.1  The one-year, long-term safety extension study found no clinically significant adverse changes, including no clinically meaningful endometrial findings, no treatment-emergent adverse events of pelvic organ prolapse or venous thromboembolism, and no cases of endometrial hyperplasia or carcinoma.2 In both studies, hot flushes were the most common treatment-related adverse event.
 

References

1. Ospemifene, a novel selective estrogen receptor modulator for treating dyspareunia associated with postmenopausal vulvar and vaginal atrophy. Menopause. 2013 Jan 28. [Epub ahead of print].
2. Simon JA, Lin VH, Radovich C, Bachmann GA; The Ospemifene Study Group. One-year long-term safety extension study of ospemifene for the treatment of vulvar and vaginal atrophy in postmenopausal women with a uterus. Menopause. 2012 Nov 8. [Epub ahead of print].
 
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