I would like everyone to know of the most recent FDA approved drug for women. In a press release on Feb 26, 2013 Shionogi & Co., Ltd. announced that the F.D.A. has approved a non-steroidal treatment for women with dyspareunia due to menopause.
The U.S. Food and Drug Administration (FDA) has approved Osphena™ (ospemifene) tablets for the treatment of moderate to severe dyspareunia (painful intercourse), a symptom of vulvar and vaginal atrophy (VVA), due to menopause.
Osphena™, as an estrogen agonist/antagonist with tissue selective effects, is the first and only oral treatment alternative to vaginal or oral steroidal estrogens for women with dyspareunia due to menopause. Its biological actions are mediated through binding to estrogen receptors, which results in activation of estrogenic pathways in some tissues (agonism) and blockade of estrogenic pathways in others (antagonism). The efficacy and safety of Osphena™ was demonstrated in three clinical trials. Osphena™ demonstrated significant improvements in dyspareunia (painful intercourse) as well as on the physical changes of the vagina associated with menopause. These improvements include increased superficial cells and decreased parabasal cells and vaginal pH.
They also reported that more than half of all women in the U.S. will experience these symptoms at some time after menopause.
"The FDA approval of Osphena™ represents an important advancement in the treatment of dyspareunia, providing an alternative treatment option for the millions of women living with this condition," said John Keller, Ph.D., President and Chief Executive Officer, Shionogi Inc. "We look forward to building our product portfolio in women's health by advancing important therapies, such as Osphena™."
Shionogi obtained exclusive global marketing rights to Osphena™ under a license agreement entered into between Shionogi and QuatRx Pharmaceuticals Company in 2010.
Osphena™ is an estrogen agonist/antagonist with tissue selective effects. Serious risks of estrogen-alone therapy can include increased risk of endometrial cancer, stroke, and deep vein thrombosis (DVT). Osphena™ should be prescribed for the shortest duration consistent with treatment goals for the individual woman. Women considering treatment for dyspareunia are encouraged to discuss the potential risks and benefits of Osphena™ with their healthcare provider.
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