First-ever medical treatment for uterine fibroids - FIBRISTAL™ - Now available in Canada

First-in-class medication shrinks uterine fibroids, rapidly controls symptoms, and safely and effectively helps restores quality of life

TORONTO, July 23, 2013 /CNW/ - Almost one in three Canadian women of reproductive age have uterine fibroids,1 making it the most common gynecological tumour1 and a leading cause of hysterectomies in this country.1 Until now, women had few options available to manage the condition. But today, Canadian women with symptomatic uterine fibroids, suffering from debilitating symptoms like excessive uterine bleeding, pain, abdominal bloating and infertility,2 have new hope.

FIBRISTAL™ (ulipristal acetate), recently approved by Health Canada, is now available for the treatment of the signs and symptoms of uterine fibroids in adult women of reproductive age who are eligible for surgery.3 A once-daily oral medication, FIBRISTAL is the first and only approved non-surgical treatment that actually reduces fibroid size, as well as rapidly controls bleeding.3

"FIBRISTAL represents a significant step forward in treating uterine fibroids," says Dr. Guylaine Lefebvre, Chief, Obstetrics and Gynecology, St. Michael's Hospital. "Although one in three women is diagnosed with fibroids, we have very few treatments available for them. Surgery carries risks of complications and these risks can be increased when women have very large fibroids or anemia because they are bleeding too much. This new therapeutic option will offer women the possibility of shrinking fibroids and limit their bleeding so that if they require an intervention, they may have less risk of complications."

First Medical Treatment for Fibroids Approved in Canada
Until now, treatments for uterine fibroids in Canada included off-label medication to reduce symptoms, or surgery to remove fibroids if they become severely problematic.4 Some older medications used off-label may temporarily shrink fibroids, but often cause medical menopause, including symptoms like hot flashes.5

"Living with uterine fibroids was an absolute nightmare," says Holly Bridges, blogger and patient advocate, who was diagnosed with uterine fibroids six years ago. "For almost three years, I dealt with severe pain, extremely heavy bleeding, life-threatening anemia and exhaustion, not to mention days off work and thousands of dollars spent on supplies.  As a single mother, I was at the end of my rope. Worse, my doctor told me hysterectomy was my only option. No woman should have to suffer with this condition or feel that hysterectomy is her only option. I think it's fantastic news that a new non-surgical treatment is available, especially for women who want to have children."

FIBRISTAL is unique in that it rapidly addresses the troubling symptoms of heavy bleeding while directly reducing fibroid size, and is very well tolerated.6,7 Notably, the shrinkage in fibroid size was maintained for six months after three months of treatment.8

"We are deeply committed to women's health, and FIBRISTAL represents the first of many innovative products we'll bring to Canadian women," says Robert Tessarolo, General Manager, Actavis Speciality Pharmaceuticals, Co., Canada.

Burden of Uterine Fibroids
Thirty percent of Canadian women of reproductive age have uterine fibroids.9 Symptoms such as abnormally heavy and prolonged bleeding, pelvic pain and pressure, iron-deficiency anemia and menstrual pain,2 can be debilitating, interfering with daily activity and significantly reducing quality of life.10 If left untreated, fibroids can lead to fertility issues and complications during pregnancy.11

Uterine fibroids also have a serious impact on quality of life: more than half of women (54 per cent) in an international epidemiological survey said uterine fibroid symptoms negatively impacted their daily lives.12

Uterine fibroids also impact the economy, costing the Canadian healthcare system more than $130 million per year for surgical procedures alone.13 Furthermore, women with moderate to severe symptoms visit the doctor twice as often as women without fibroids,14 and uterine fibroids can lead to absenteeism, diminished work performance and decreased productivity.15

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 both 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.3

The efficacy of FIBRISTAL was evaluated in two pivotal Phase 3 randomized, double-blind, multicentre, 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).3

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.3 The duration of treatment is limited to three months.3 FIBRISTAL is now available in Canada, following its approval by Health Canada on June 24, 2013. FIBRISTAL is marketed under license from Gedeon Richter Plc. (www.richter.hu).

About Actavis, Inc.
Actavis, Inc. -previously known as Watson Pharmaceuticals, Inc.—is a global, integrated specialty pharmaceutical company focused on developing, manufacturing and distributing generic, brand and biosimilar products. The Company has global and U.S. headquarters in Parsippany, New Jersey, USA, and Canadian head offices in Oakville, Ontario.

Actavis Specialty Pharmaceuticals Co. - previously known as Watson Pharma Company - 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 urology and in women's health. 


References
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1 SOGC Clinical Practice Guidelines, J Obstet Gynaecol Can 2003;25(5).

2 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 17, 2013.

3 FIBRISTAL Product Monograph, June 2013.

4 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.

5 Uterine Fibroids. National Institute of Health. http://report.nih.gov/NIHfactsheets/ViewFactSheet.aspx?csid=50 Accessed June 24, 2013

6 Donnez J et al. Ulipristal Acetate Versus Placebo for Fibroid Treatment Before Surgery. New England Journal of Medicine 2012; 366 (5): 409-420.

7 Donnez J et al. Ulipristal Acetate Versus Leuprolide Acetate for Uterine Fibroids. New England Journal of Medicine 2012; 366 (5): 421-432.

8 FIBRISTAL Product Monograph, June 2013.

9 SOGC Clinical Practice Guidelines, J Obstet Gynaecol Can 2003;25(5), p. 2.

10 William VS et al. Uterine Fibroids: a review of health related quality of life assessment. J Women's Health. 2006 Sep; 15 (7): 818-29.

11 Female Infertility. Johns Hopkins. http://www.hopkinsmedicine.org/fertility/conditions/female_infertility.html Accessed June 24, 2013

12 Zimmerman et al. Prevalence, symptoms and management of uterine fibroids: an international internet-based survey of 21,746 women. BMC Women's Health 2012, 12:6.

13 Data on file: Pharmacoeconomic Analysis

14 Data on file: Epsilon

15 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.


SOURCE Actavis, Inc.

For further information:

Karley Ura
NATIONAL Public Relations
416-848-1425
kura@national.ca

Robert Tessarolo, General Manager
Actavis Specialty Pharmaceuticals Co. 
905-855-4422
rob.tessarolo@actavis.com