Actavis Inc. (ACT) announced that Health Canada has approved the company's application to market Fibristal (ulipristal acetate) for the treatment of moderate to severe signs and symptoms of uterine fibroids in adult women of reproductive age who are eligible for surgery.
The company said the breakthrough first-in-class oral treatment offers an important new option for women in Canada with uterine fibroids, the first approved medication to reduce fibroid size as well as control symptoms.
The company expects that Fibristal will be available in Canada in the third quarter of 2013.
Current treatments for uterine fibroids in Canada include off-label medication to reduce symptoms, or surgery to remove fibroids if they become severe.
According to the company, efficacy and safety were demonstrated in two double-blind, controlled, multicenter, Phase 3 studies. In both trials, Fibristal significantly reduced heavy bleeding during menstruation, pain and discomfort and the overall volume of fibroids. 3 The shrinkage in fibroid size was maintained for at least six months after three months of treatment with Fibristal.
The company noted that up to 75 percent of women will experience uterine fibroids in their lifetime. Women report excessive uterine bleeding as the most common symptom. They also suffer from painful menstruation, pelvic pain and frequent urination. Fibroids can also cause infertility. Uterine fibroids also have a serious impact on quality of life.
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by RTT Staff Writer
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