— FIBRISTAL®shown to significantly control heavy uterine bleeding, shrink fibroid volume and reduce pelvic pain for patients suffering from uterine fibroids1 —DUBLIN and MARKHAM, Ontario, Nov. 21, 2016 /PRNewswire/ -- Allergan plc (NYSE: AGN) announced today that it has received an additional approval from Health Canada for FIBRISTAL ® (ulipristal acetate, 5 mg) for the intermittent treatment of moderate to severe signs and symptoms of uterine fibroids in adult women of reproductive age. Each treatment course is three months, 2 given in repeated courses. Logo - http://photos.prnewswire.com/prnh/20150612/222796LOGO A once-daily oral medication, FIBRISTAL ® is the first and only non-surgical treatment specifically indicated to treat the signs and symptoms of uterine fibroids. In long term clinical studies FIBRISTAL ® was shown to safely and effectively control excessive uterine bleeding, shrink fibroid volume and reduce the significant pain and symptom severity scores associated with symptomatic uterine fibroids. 3,4 These benefits appear to improve over repeated courses, returning patients' quality of life measures back to levels of healthy women. "For patients who wish to avoid surgery or retain their fertility, FIBRISTAL ® is now a viable option," said Dr. Sony S Singh, MD, FRCSC, Associate Professor and Vice Chair of Gynaecology at The Ottawa Hospital and University of Ottawa. "FIBRISTAL ® specifically targets fibroids and improves heavy bleeding and other symptoms related to this common and debilitating condition. The other benefit is that this medication has been shown to be well tolerated among most women as it doesn't induce menopause." FIBRISTAL ® was first approved in 2013 but now the indication for the treatment of signs and symptoms of uterine fibroids has broadened with the addition of long term safety and efficacy studies. The Society of Obstetricians and Gynecologists of Canada (SOGC) has recently updated its clinical practice guidelines to include ulipristal acetate. The SOGC noted its strong scientific evidence for control of abnormal uterine bleeding, rapid onset of action, anemia correction and reduction in bulk symptoms. 5 "The approval of FIBRISTAL ® for long term intermittent use is an important step in changing the lives of Canadian women who live with this challenging condition and need a highly effective and safe medical therapy option," said Ed Gudaitis, General Manager at Allergan Canada. "The evolution of this new medication demonstrates an innovative alternative in the standard of care for uterine fibroids, Allergan's commitment to improving women's health, and we look forward to continuing to bring innovative medicines to women of all ages." About uterine fibroidsSeventy to eighty per cent of Canadian women of reproductive age have uterine fibroids, which are the leading cause of hysterectomies in Canada. 6 The most common symptom of uterine fibroids is abnormal uterine bleeding, which causes pain and heavy, prolonged periods. 7 If left untreated, uterine fibroids can impact fertility and cause complications during pregnancy. 8 In a Canadian survey of over 11,000 women aged 20 to 49, those who had uterine fibroids with moderate to severe symptoms experienced a significantly heavier burden of illness, lost productivity and reduced quality of life. 9 Symptoms of uterine fibroids usually resolve with menopause, at which time treatments are stopped. About FIBRISTAL ®FIBRISTAL ® belongs to a class of medications called selective progesterone receptor modulators (SPRMs). It is an oral partial progesterone antagonist that exerts a direct effect on the endometrium to control excessive bleeding, and on fibroids where it inhibits cell proliferation and induces apoptosis (cell death) to reduce their size. 10 A treatment course is three months of continuous use followed by a treatment-free interval of two menstrual cycles and continued with intermittent courses as necessary. 11 The efficacy of FIBRISTAL ® was evaluated in two long-term Phase III studies, PEARL III and PEARL IV, involving 132 and 451 patients respectively. Both studies confirmed the efficacy and safety of the intermittent long term use of FIBRISTAL ®. 12,13 The results of the PEARL IV study included control of uterine bleeding, reduction in fibroid volume, reduction in pelvic pain, correction in anemia and improvement in quality of life. The most common adverse drug reactions (= 5 per cent) in the clinical trials for women receiving FIBRISTAL ® were hot flashes and headaches. The vast majority of adverse drug reactions were mild or moderate, decreased with repeated courses, and did not lead to discontinuation of the medication. 14 To date, more than 300,000 women in 57 countries have been treated with FIBRISTAL ®. 15About Allergan PLCAllergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a bold, global pharmaceutical company and a leader in a new industry model - Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceuticals, devices and biologic products for patients around the world. Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories.