Novo Nordisk has received FDA has approval for 10mcg dose formulation of Vagifem (estradiol vaginal tablets) for the treatment of atrophic vaginitis due to menopause. The approval makes Vagifem 10mcg the lowest local estrogen therapy (LET) dose commercially available in the US. It will be available in pharmacies in the first quarter of 2010.
Vagifem is the prescription vaginal tablet in a ready-to-use applicator designed to relieve the symptoms and discomfort associated with atrophic vaginitis. Vagifem was first approved as a 25mcg tablet in the US in 1999 and in 1988 in Europe.
The company said that unlike oral hormone therapy (HT), Vagifem 10mcg delivers estrogen directly to the vagina via a small tablet that is easy to insert by a ready-to-use applicator, with only minimal absorption throughout the body. The estrogen in Vagifem 10mcg, 17beta-estradiol, is chemically identical to estrogen produced by a woman’s body before menopause.
Reportedly, the approval of Vagifem 10mcg is based on a randomised, placebo-controlled 52-week multicenter trial, which found statistically improvement with Vagifem 10mcg versus placebo after 12 weeks treatment. The result of the study suggested that one year of continuous treatment with Vagifem 10mcg tablets was also safe and well-tolerated by patients.
Eddie Williams, vice president of biopharmaceuticals at Novo Nordisk, said: “We are very pleased to offer the millions of postmenopausal women who experience symptoms associated with vaginal atrophy a lower dose treatment option that works at the location of their discomfort. Vagifem 10mcg effectively addresses a spectrum of symptoms, such as vaginal dryness, itching, and painful intercourse, that can disrupt their day-to-day lives.”