New SOGC guidelines now include FIBRISTAL™ - Only medical treatment approved for uterine fibroids

TORONTO, June 4, 2015 /CNW/ - The Society for Obstetrics and Gynecology of Canada (SOGC) has issued updated guidelines for the management of uterine fibroids (uterine leiomyomas), which now include the first and only approved medical treatment for uterine fibroids: FIBRISTAL (ulipristal acetate).¹

FIBRISTAL was recommended, based on Level 1 evidence, for treatment of abnormal uterine bleeding associated with fibroids, bulk symptoms and anemia correction. The SOGC guidelines state that studies show "[ulipristal acetate] …effectively and safely controlled bleeding and shrunk fibroids in patients with symptomatic fibroids …of all the hormonal options available for women with fibroids, ulipristal acetate has the most rapid documented onset of action and control of bleeding."¹

"These new guidelines are the result of a comprehensive scientific evidence review, and reflect the most up-to-date best practices in the management of uterine fibroids," says Dr. George Vilos, the lead author of the SOGC Guidelines on the management of uterine fibroids and Professor of Obstetrics and Gynecology at Western University in London, Ontario. "The inclusion of FIBRISTAL is an acknowledgment of its importance in the management of this very common and challenging condition."

FIBRISTAL was approved in Canada in June 2013 for the treatment of moderate to severe signs and symptoms of uterine fibroids in adult women of reproductive age who are eligible for surgery.² It is the only Health Canada approved medical treatment for uterine fibroids. Currently, the only provincial drug program providing access to FIBRISTAL is in Quebec; women under public insurance in all other provinces do not have access to FIBRISTAL.

Until the availability of FIBRISTAL, treatments for uterine fibroids in Canada included off-label medication to reduce symptoms, or surgery to remove individual fibroids (myomectomy) or the woman's whole uterus (hysterectomy) if the condition became debilitating.³

ABOUT FIBRISTAL

FIBRISTAL is the first in a new class of medications called selective progesterone receptor modulators (SPRMs). It is an orally active, partial progesterone antagonist that exerts both a direct effect on the lining of the uterus (endometrium) to control excessive bleeding, and on fibroids where it inhibits cell proliferation and induces apoptosis (cell death) to reduce their size.²

The efficacy of FIBRISTAL was evaluated in two pivotal Phase 3 randomized, double-blind, multi-centre, 13-week studies (PEARL I and PEARL II, published in the New England Journal of Medicine in February 2012). The most common adverse drug reactions in the clinical trials for women receiving FIBRISTAL 5 mg were hot flushes (13.0 per cent overall) and headaches (8.3 per cent overall).²

FIBRISTAL is indicated for treatment of moderate to severe signs and symptoms of uterine fibroids in adult women of reproductive age who are eligible for surgery.  The duration of treatment is limited to 3 months. Please see FIBRISTAL product monograph for complete list of contraindications, warnings and precautions and adverse reactions.²

ABOUT ACTAVIS PLC
Actavis plc is a global, integrated specialty pharmaceutical company focused on developing, manufacturing and distributing, brand, biosimilar and generic products. Actavis has global headquarters in Dublin, Ireland and U.S. administrative headquarters in Parsippany, New Jersey, USA.

Actavis Specialty Pharmaceuticals Co. based in Mississauga, Ontario, is the company's branded specialty pharmaceutical business in Canada engaged in the marketing, sale and distribution of specialty pharmaceutical products within the Canadian market. Actavis Specialty Pharmaceuticals Co. is focused on delivering innovative products that address key therapeutic categories in women's health, urology, GI and osteoporosis. 

References

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¹ Clinical Practice Guidelines: The Management of Uterine Leiomyomas. Society of Obstetricians and Gynaecologists of Canada.
² FIBRISTAL Product Monograph, June 2013.
³ Uterine Fibroids. The American College of Obstetricians and Gynecologists. http://www.acog.org/~/media/For%20Patients/faq074.pdf?dmc=1&ts=20130617T1137475270. Last accessed July 2, 2013.

SOURCE Actavis Specialty Pharmaceuticals Co.

For further information: Sarah Bannoff, NATIONAL Public Relations, 416-848-9851, [e-mail]