PREMARIN(R) (conjugated estrogens) Vaginal Cream 0.5 g has been approved by the U.S. Food and Drug Administration (FDA) for a new indication and a new less frequent twice-weekly dosing regimen to treat moderate to severe postmenopausal dyspareunia (painful sexual intercourse) announced Wyeth Pharmaceuticals, a division of Wyeth.
"This approval is welcome news, especially when you consider that more than one in four untreated postmenopausal women experience dyspareunia, a symptom of vulvar and vaginal atrophy, which typically does not subside without treatment," says Gloria Bachmann, M.D., Director of the Women's Health Institute at the University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School, New Brunswick, N.J. and Chief of the OB/GYN service at the teaching hospital.
PREMARIN Vaginal Cream is the first vaginal estrogen therapy indicated for the treatment of moderate to severe dyspareunia due to menopause. A low-volume regimen of PREMARIN Vaginal Cream can treat painful intercourse due to menopause, restore vaginal tissue, and reverse changes in the vagina that occur with menopause.
The approval is based on efficacy results from a multicenter clinical study that included a 12-week randomized, double-blind placebo phase followed by a 40-week open-label phase. Results from the 12-week phase showed that both low-dose regimens of PREMARIN Vaginal Cream (0.5 g daily [21 days on/7 days off] or twice weekly) significantly improved the dyspareunia score versus placebo at 12 weeks. In this study, dyspareunia was one of the most bothersome symptoms of vulvar and vaginal atrophy. Endometrial safety was assessed in women who completed the 52-week study period and had evaluable endometrial biopsies. There were no reports of endometrial hyperplasia or endometrial carcinoma in these women in either regimen.
"This new indication for PREMARIN Vaginal Cream, with a low volume of 0.5 g and two different dosing regimens — 21 days on/7 days off or twice weekly — gives health care professionals and women a new option in treating moderate to severe dyspareunia due to menopause," says Eileen Helzner, M.D., Assistant Vice President, Global Medical Affairs, Wyeth Pharmaceuticals.
Bepotastine was approved in Japan for use as a systemic drug in the treatment of allergic rhinitis and urticaria/pruritus in July 2000 and January 2002, respectively, and is marketed by Mitsubishi Tanabe Pharma Corporation (formerly Tanabe Seiyaku Co., Ltd.) under the brand name TALION®. TALION was co-developed by Tanabe Seiyaku and Ube Industries, Ltd., who discovered bepotastine.