Quebec is first province to list FIBRISTAL™ - the first and only medication for uterine fibroids - on provincial formulary

Quebec acts quickly in support of women's health, as the first province to provide access to Fibristal in Canada 

TORONTO, Feb. 6, 2014 /CNW/ - Actavis Specialty Pharmaceuticals Co. applauds the Quebec Ministry of Health and Social Services' decision to reimburse FIBRISTAL™ (ulipristal acetate), a first-in-class medical treatment for uterine fibroids, on its provincial formulary without restriction. Almost one-in-three Canadian women of reproductive age have uterine fibroids;¹ it is the most common gynecological tumour,² and a leading cause of hysterectomies in Canada.³

"We welcome Quebec's decision to list FIBRISTAL and give women in Quebec access to this new important treatment option," says Dr. Isabelle Girard, President of the Association of Obstetricians and Gynecologists of Quebec (AOGQ).  "Uterine fibroids can disrupt a woman's life, causing debilitating symptoms like heavy uterine bleeding, anemia, pain and, in some cases, infertility. This listing gives women in Quebec suffering with uterine fibroids a proven medication to treat this condition."

A once-daily oral medication, FIBRISTAL is the first and only approved medication for uterine fibroids that both reduces fibroid size and rapidly controls bleeding.⁴ Until the approval of FIBRISTAL, treatments for uterine fibroids in Canada included off-label medication, including intramuscular injections to reduce symptoms, or surgery to remove fibroids if they become severely problematic.⁵

"The decision to list FIBRISTAL by the Quebec government is important, given the limited treatment options for uterine fibroids," says Dr. Jennifer Blake, CEO of the Society and Obstetricians and Gynecologists of Canada. "Providing access to a non-surgical option will have a significant impact on the lives of women in Quebec affected by uterine fibroids. In so doing, Quebec has demonstrated strong commitment to women's health, as the first province to list this new treatment."

"The Quebec formulary listing is an important step toward giving women access to FIBRISTAL, the only medication approved for uterine fibroids in Canada" says Rob Tessarolo, General Manager, Actavis Specialty Pharmaceuticals Co., Canada. "We are working with all stakeholders to make sure FIBRISTAL is accessible to all Canadian women suffering from uterine fibroids. We are committed to women's health and look forward to continue to bring innovative treatments to Canada."

UTERINE FIBROIDS IN CANADA - FAST FACTS

• Thirty percent of Canadian women of reproductive age have uterine fibroids.⁶
• Uterine fibroids are a leading cause of hysterectomies.⁷
• Untreated uterine fibroids can lead to fertility issues and complications during pregnancy.⁸
• Uterine fibroids cost the Canadian healthcare system more than $130 million per year for surgical procedures alone.⁹
• Women with moderate to severe symptoms visit the doctor almost twice as often as women without fibroids.¹⁰
• Uterine fibroids can lead to absenteeism, diminished work performance, and decreased productivity.¹¹

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 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.¹²

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).¹³

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.¹⁴

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 Oakville, 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 SOGC Clinical Practice Guidelines, J Obstet Gynaecol Can 2003;25(5).
² SOGC Clinical Practice Guidelines, J Obstet Gynaecol Can 2003;25(5).
³ SOGC Clinical Practice Guidelines, J Obstet Gynaecol Can 2003;25(5).
⁴ FIBRISTAL Product Monograph, June 2013.
⁵ 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.
⁶ SOGC Clinical Practice Guidelines, J Obstet Gynaecol Can 2003;25(5), p. 2.
⁷ SOGC Clinical Practice Guidelines, J Obstet Gynaecol Can 2003;25(5).
⁸ Female Infertility. Johns Hopkins. http://www.hopkinsmedicine.org/fertility/conditions/female_infertility.html Accessed June 24, 2013
⁹ Data on file: Pharmacoeconomic Analysis
¹⁰ Data on file: Epsilon
¹¹ Downes E et al. The burden of uterine fibroids in five European countries. European Journal of Obstetrics & Gynaecology and Reproductive Biology 2010;152(1):96-102.  Accessed July 5, 2013.
¹² FIBRISTAL Product Monograph, June 2013.
¹³ FIBRISTAL Product Monograph, June 2013.
¹⁴ FIBRISTAL Product Monograph, June 2013.

SOURCE: Actavis, Inc.