FDA approves Premarin cream to treat dyspareunia
November 14th, 2008 by Jennifer Walker-Journey
Wyeth Pharmaceuticals recently announced FDA approval of its Premarin Vaginal Cream to treat moderate to severe dyspareunia, or painful sexual intercourse, according to RTT News.
Premarin is a low-dose mixture of estrogen hormones and is already available in pill form to treat symptoms of menopause such as hot flashes and vaginal dryness, burning and itching. Premarin and another Wyeth drug prescribed for menopausal symptoms, Prempro, dominated the hormone replacement therapy market until the Women’s Health Initiative of 2002 linked long-term use of HRT to an increased risk of breast cancer and other serious health problems. Wyeth has since been faced with numerous lawsuits concerning the drugs.
Dyspareunia is a disorder that follows the atrophy or thinning of the vagina and vulva, a condition that can occur in menopause.
The .5-gram cream has two dosing regiments – 21 days on followed by 7 days off, or twice weekly. FDA approval of the cream and its dosing regime was granted based on results from a multi-center clinical study that included a 12-week, randomized, double blind placebo phase followed by a 40-week open-label phase, according to the story.
Wyeth advises women considering the cream to review possible side effects with their physician, and to avoid the product if they fall into a high-risk category.