Non-Estrogen Therapy Helps in Treatment of Common Menopause Symptoms
There are 42 million postmenopausal women in the United States. It is estimated that 45-75 percent suffer from menopause symptoms like vulvovaginal atrophy (VVA). QuatRx Pharmaceuticals, a privately-held biopharmaceutical company in Ann Arbor, Michigan, has announced positive results from their second pivotal Phase 3 clinical study for Ophena™ (ospemifene tablets), an investigational therapy in development for the treatment of postmenopausal vaginal atrophy.
The results show that treatment of common menopause symptoms with Ophena™ has a positive impact in four key areas among women who report that they experience sexual pain as a result of vaginal atrophy.
In the study, women treated with Ophena™ reported less pain during intercourse. They also showed improvements in several clinical measures including a decrease in parabasal cells and an increase in superficial cells from vaginal smear, as well as a decrease in vaginal pH levels.
Based on these positive results, QuatRx is planning to file a New Drug Application (NDA) for Ophena with the U.S. Food and Drug Administration (FDA) in early 2010.
“These findings provide extensive additional evidence indicating the potential of Ophena™ to be a first- in – class non-estrogen drug for the treatment of vaginal atrophy,” said Robert L. Zerbe, M.D., Chief Executive Officer of QuatRx. “We are working aggressively to move forward with our NDA submission and to bring this promising treatment option to the millions of women affected by vaginal atrophy who want an alternative to estrogen therapy.”
Postmenopausal VVA is a chronic and progressive condition characterized by symptoms including vaginal dryness, irritation and pain or bleeding during sexual intercourse. Current prescription treatments approved for this condition all contain estrogen, administered either orally or locally in the vagina. Ophena™ belongs to a class of drugs known as selective estrogen receptor modulators (SERMs). SERMs that are currently approved and marketed in the U.S. have not been shown to have beneficial effects on vaginal tissue, and none is approved for use in treating vaginal atrophy symptoms.
The second Phase 3 clinical trial for Ophena™ included 919 women with vulvovaginal atrophy who were treated at 116 participating sites in the United States. In the 12-week placebo controlled trial a cohort of 605 women who identified sexual pain as their most bothersome symptom were studied. The results showed highly significant changes within 12 weeks as compared to placebo. All women were supplied with non-hormonal vaginal lubricant to be used as needed during the treatment period and the study results demonstrated efficacy above and beyond this lubricant usage.
The company also recently completed a long term safety program for Ophena™. Data from the long term safety studies show that daily doses of 60 mg of Ophena™ are well-tolerated with most treatment-emergent adverse events being mild or moderate in severity. Overall, the safety profile of Ophena™ compares favorably to estrogen treatment, which remains the only class of drugs available for this menopausal symptom.
Written by Lynn Granito
Berry & Company Public Relations