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. Premarin vaginal cream is only available by prescription.
According to the company, Premarin vaginal cream is the first vaginal estrogen therapy indicated for the treatment of moderate to severe dyspareunia due to menopause.
Eileen Helzner, assistant vice president of global medical affairs at Wyeth Pharmaceuticals, said: “This new indication for Premarin vaginal cream, with a low volume of 0.5g and two different dosing regimens – 21 days on/seven days off or twice weekly – gives health care professionals and women a new option in treating moderate to severe dyspareunia due to menopause.”