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FDA Approves New Drug for Treating Painful Sex

Update Date: Feb 27, 2013 03:02 PM EST

U.S. based company Shionogi & Co. Ltd has developed a new drug for people suffering from dyspareunia, a condition in which sexual intercourse becomes painful. The Shionogi drug, OsphenaTM also known as ospemifene, is an oral treatment for the condition and was just approved by the Food and Drug Administration (FDA) for people with moderate to severe cases of the dyspareunia. Dyspareunia can occur in postmenopausal women and as a symptom of vulvar and vaginal atrophy, which is the thinning and inflammation of the vagina as a result of decreasing levels of estrogen. The most common causes of that result in lowered numbers of estrogen are menopause and pregnancies.

"Dyspareunia is among the problems most frequently reported by postmenopausal women," Dr. Victoria Kusiak stated. "Osphena provides an additional treatment option for women seeking relief." Dr. Kusiak is currently the deputy director of the office of Drug Evaluation III under the FDA's Center for Drug Evaluation and research. There are roughly 32 million women suffering from this condition in the United States, which will be a huge market for osphena now that it has been approved. Osphena will be the first tablet treatment option available for U.S. women. Previous treatment options included vaginal or oral estrogens.

"The FDA approval of OsphenaTM represents an important advancement in the treatment of dyspareunia, providing an alternative treatment option for the millions of women living with this condition," President and Chief Executive Officer of Shionogi Inc., John Keller, Ph.D stated in the company's press release.

Osphena is an estrogen receptor modulator that helps increase the amount of estrogen in the body. It works as an estrogen agonist/antagonist, attaching to estrogen receptors in the body and triggering their estrogen production or blockage depending on the pathway in the body. The company went through three clinical trials to determine the safety and effectiveness of the drug.

Shionogi has not set up a price for the drug yet. However, in 2010, the QuatRx Pharmaceuticals based in Ann Arbor, MI estimated the drug to be worth $25 million upfront with more than $100 million in milestones based from Phase III studies. The FDA is currently reviewing another oral treatment, bazedoxifene. 

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