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| |  Ospemifene Shows Efficacy at Reducing Vaginal Dryness and Pallor: Presented at NAMS By John Otrompke SAN DIEGO -- October 4, 2009 -- Ospemifene shows beneficial efficacy compared with placebo, according to a phase 3 trial presented here at the 20th Annual Meeting of the North American Menopause Society (NAMS). Ospemifene is a selective oestrogen receptor modulator (SERM) that is being developed for the relief of vulvovaginal atrophy in postmenopausal women. “A SERM binds to oestrogen receptors and it has the unique property that it can act as an agonist against some tissue, but an antagonist in others,” said David Portman, MD, Columbus Center for Women’s Health Research, Ohio State University College of Medicine, who presented the study on October 1. “Most SERMs seen to date are neutral at the vagina, but effective at the bone and breast. Preclinical studies show that ospemifene has anti-oestrogen effects at the breast.” The study tested the effect of ospemifene on symptoms of vulvovaginal atrophy among postmenopausal women. Symptoms of vulvovaginal atrophy, in which the skin of the vagina becomes thinner, drier or more easily injured, include dryness, pallor, redness, friability, or petechiae. “Friability is a sign that the vaginal mucosa is thin and easily injured,” Dr. Portman explained. “It means that the actual mucosa is very thin and rough in appearance, rather than smooth and healthy. Petechiae are signs of bleeding: the skin gets more easily injured, and you can see areas of haemorrhage when you do a screening or put an instrument in,” he added. “However, the symptoms of dryness and pallor look to be the most statistically consistent with an effect of the drug.” In the study, 69 patients receiving ospemifene 60 mg and 49 patients receiving placebo who had been enrolled in the initial 3-month efficacy study for the drug were continued in a double-blind extension study for an additional 9 months. The women ranged in age from 40 to 80 years. Vulvovaginal atrophy was defined as having 5% or fewer superficial cells on vaginal smear, a vaginal pH of more than 5, and at least 1 moderate or severe self-assessed symptom. Symptoms included pain during sex, dryness, itching or irritation, or bleeding associated with sex. At baseline, the highest mean severity scores for the clinical signs were observed for vaginal dryness in mucosa and pallor, which both showed a significant improvement with ospemifene. At 6 months, the mean severity score for dryness decreased by 1.4 compared with 0.8 for placebo, while for pallor it had decreased by approximately 1.2 to approximately 0.5 for placebo. At 12 months, the reduction was by nearly 1.4 points for ospemifene compared with a little over 1.0 for placebo, and about 1.2 for pallor compared with 0.6 for placebo. However, improvements in redness, friability, and petechiae did not reach statistical significance. Funding for this study was provided by QuatRx Pharmaceuticals Company. [Presentation title: Long-Term Effects of Ospemifene on the Clinical Signs of Vaginal Atrophy. Abstract P-42]
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