More Good News From QuatRx On Women's Drug

Results presented at 12th World Congress on the Menopause show significant improvement in vaginal dryness and dyspareunia, two of the most frequent symptoms associated with vulvovaginal atrophy

Ann Arbor-based QuatRx Pharmaceuticals Wednesday announced more positive data from its Phase 3 clinical study of its drug candidate Ophena.

The drug is intended to treat postmenopausal women with symptoms of vulvovaginal atrophy, a common condition associated with menopause. The company reported initial positive results of the study in January.

More analysis of the results, the company said, showed that women treated with Ophena experienced improvements in vaginal dryness and dyspareunia (painful intercourse), two of the most frequent symptoms associated with vulvovaginal atrophy.

Results of this analysis were presented Wednesday at the 12th World Congress on the Menopause in Madrid, Spain.

The multi-center, double-blind, placebo-controlled study was conducted in 80 U.S. centers and involved 826 postmenopausal women. Fully 90 percent of women in the study experienced moderate to severe vaginal dryness and 66 percent experienced moderate to severe dyspareunia. Following 12 weeks of treatment with Ophena, the decrease in the symptom score for patients reporting moderate to severe vaginal dryness was statistically significant as compared to placebo. The symptom score for patients reporting moderate to severe dyspareunia also showed a statistically significant decrease as compared to placebo. Ophena was generally well tolerated and demonstrated a favorable safety profile.

"For millions of post-menopausal women, the symptoms of vulvovaginal atrophy represent a serious health issue that can have a profound negative impact on quality of life," said Dr. James A Simon, clinical professor of obstetrics and gynecology at George Washington University. "These results from the Phase 3 clinical trial for Ophena show that a non-estrogen therapy may provide significant benefits for post-menopausal women affected by vaginal dryness and dyspareunia, two of the most common and debilitating symptoms of vulvovaginal atrophy."

Ophena is a novel selective estrogen receptor modulator that is being studied as a non-estrogen alternative for the treatment of postmenopausal vaginal syndrome, also known as vaginal atrophy. The only FDA approved products currently available to treat PVS contain the hormone estrogen. Treatment with estrogen replacement therapy has been associated with certain health risks including an increased risk of breast cancer.

"For women who are concerned about the health risks of estrogen therapy, currently available treatment options for symptoms of vulvovaginal atrophy are limited and inadequate," said Dr. Robert Zerbe, president and CEO of QuatRx. "These study results indicate that Ophena has the potential to be the first non-estrogen treatment option that provides a clear clinical benefit. We are working to advance the development program for Ophena to make this important therapy available to all women who would benefit from it."

More at www.quatrx.com.