ANN ARBOR, Mich, June 16 /PRNewswire/ -- QuatRx Pharmaceuticals today announced detailed primary endpoint results from a pivotal Phase 3 clinical trial of Ophena(TM) (ospemifene tablets) to treat postmenopausal women with symptoms of vulvovaginal atrophy, a common condition associated with menopause. The study successfully met all four co-primary endpoints. Women treated with Ophena(TM) at the 60 mg dose showed statistically significant improvements in vaginal dryness and dyspareunia (painful intercourse), as well as statistically significant improvement in the proportion of parabasal and superficial cells in the epithelium of vaginal walls and a decline in vaginal pH levels. Results of this Phase 3 clinical trial were presented today in a poster presentation at the 90th annual Endocrine Society meeting in San Francisco.
The decline in estrogen levels in women after menopause is associated with an increase in vaginal pH levels as well as a thinning of the vaginal wall, resulting in bothersome symptoms such as vaginal dryness and painful intercourse. In the Phase 3 Ophena(TM) clinical study, women were asked to identify their most bothersome symptom of vaginal atrophy. The co-primary endpoints were defined as the change from baseline to week 12 in the percentage of parabasal cells in the vaginal maturation index, the percentage of superficial cells in the vaginal maturation index, vaginal pH, and improvements in the most bothersome moderate to severe vulvovaginal atrophy symptom.
"Vaginal atrophy symptoms in postmenopausal women are usually progressive and, unlike hot flashes, do not resolve spontaneously. They can have a significant impact on a woman's quality of life. These Phase 3 clinical study results indicate that this new oral tablet has the potential to address the most common and debilitating chronic symptoms of vaginal atrophy for millions of women in the years ahead," said Dr. Gloria A. Bachmann, Associate Dean for Women's Health and Professor of Ob/Gyn & Medicine at the University of Medicine and Dentistry of New Jersey, Robert Wood Johnson Medical School.
The study investigated treatment with Ophena(TM) administered orally, once-daily at 30 and 60 mg doses as compared to a placebo. Women were randomized (1:1:1) into a double-blind 12-week treatment period with a four- week follow-up or the opportunity to continue in a long-term safety extension study. All women were supplied with a non-hormonal vaginal lubricant to be applied as needed during the 12-week treatment period.
"These Phase 3 clinical study results also show that treatment with Ophena(TM) has the potential to offer advantages in addition to the use of vaginal lubricants. There are currently no prescription alternatives available for postmenopausal women with symptoms of vaginal atrophy who are concerned about the risks of treatment with estrogen. Over-the-counter vaginal lubricants may help temporarily ease some symptoms of vulvovaginal atrophy associated with intercourse for some women, but they do not treat the underlying progressive condition which is the source of these chronic vaginal symptoms" said Robert Zerbe, M.D., president and chief executive officer of QuatRx.
Following 12 weeks, women treated with 60 mg of Ophena(TM) who identified dryness or painful intercourse as their "most bothersome" symptom, showed significant improvements in each of these symptoms. Women treated with this dose of Ophena(TM) also showed a favorable effect on the health of their vaginal wall cells as compared to the placebo. There was an average 30 percent decrease in parabasal cells (which indicate an atrophic state) as compared to an increase of four percent with placebo and an average 11 percent increase in superficial cells (which indicate a well estrogenized effect) as compared to two percent with placebo. The decrease in pH to a more favorable one in the treatment group was also statistically significant as compared to placebo (-1.01 ± 1.1 versus -0.10 ± 0.8). Ophena(TM) was generally well tolerated and demonstrated a favorable safety profile.
Ophena(TM), a novel selective estrogen receptor modulator (SERM), is being studied as a non-estrogen alternative for the treatment of symptoms of postmenopausal vaginal syndrome (PVS), also known as vaginal atrophy. The only FDA approved prescription products currently available to treat PVS contain estrogen. Treatment with estrogen therapy has been associated with certain health risks, and many women prefer non-estrogen alternatives.
"These results provide strong support for our efforts to advance Ophena(TM) through the regulatory review process. Our next Phase 3 trial for Ophena(TM) will begin later this year. We remain committed to completing the necessary clinical studies and regulatory filings in support of Ophena(TM) as quickly as possible to make this non-estrogen treatment option available to the millions of women affected by vulvovaginal atrophy around the world" added Robert Zerbe, M.D.
About Postmenopausal Vaginal Syndrome
Postmenopausal vaginal syndrome (PVS) 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 up to 45-75 percent of post-menopausal women have chronic symptoms of PVS. 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 symptoms of PVS.
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 active clinical development and an advanced preclinical program. Fispemifene is a new selective estrogen receptor antagonist that is in Phase 2 studies as an oral treatment for the symptoms of secondary hypogonadism in men. Sobetirome, a novel, selective thyroid receptor beta agonist, is in Phase 1 studies as a potential treatment for dyslipidemia. Asord(TM) (becocalcidiol), a novel Vitamin D analogue, is in Phase 2 clinical trials for the treatment of psoriasis through QuatRx's partner, Galderma. QuatRx's preclinical program is designed to address sex steroid dependent diseases through inhibition of 17beta-HSD enzymes. In Europe, QuatRx operates through its Finnish subsidiary, Hormos Medical Ltd, located in Turku, Finland. For press releases and other Company information, please visit www.quatrx.com.
CONTACT: Julia Owens of QuatRx Pharmaceuticals Comp, +1-734-913-9900 x121
Web site: http://www.quatrx.com/