QuatRx Announces Positive Results of Second Pivotal Phase 3 Clinical Study for Ophena(TM) (Ospemifene Tablets) in Treatment of Postmenopausal Vagin...(olled one year study involving 426 women...),Health

Date:9/10/2009

olled, one year study involving 426 women with an intact uterus, randomized 6:1 to Ophena designed to evaluate long term endometrial safety. Data from the long term safety studies show that daily doses of 60mg of Ophena(TM) are well-tolerated with most treatment-emergent adverse events being mild or moderate in severity. There were no deaths in any of the studies and no confirmed cases of endometrial hyperplasia or carcinoma. Overall, the safety profile of Ophena(TM) compares favorably to estrogen treatment, which remains the only class of drugs available for this condition.

About Postmenopausal Vaginal Atrophy

Postmenopausal vulvovaginal atrophy is a chronic and progressive condition characterized by symptoms including vaginal dryness, sexual pain (dyspareunia) and irritation. Declining estrogen levels during menopause can cause tissues of the vaginal lining to grow thinner and to lose elasticity, a condition known as atrophy. Dryness and irritation associated with reductions in vaginal secretions often cause pain or bleeding during sexual intercourse. It is estimated that 45-75 percent of postmenopausal women experience chronic symptoms of vaginal atrophy, and in most cases these symptoms are highly bothersome to patients. Current prescription treatments approved for this condition all contain estrogen, administered either orally or locally in the vagina. SERMs that are currently approved and marketed in the United States have not been shown to have beneficial effects on vaginal tissue and none are approved for use in treating vaginal atrophy symptoms.

About QuatRx

QuatRx Pharmaceuticals is focused on the discovery, licensing, development and commercialization of compounds in the endocrine, metabolic and cardiovascular therapeutic areas. In addition to Ophena(TM), QuatRx has three other product candidates in clinical development and preclinical program
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