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
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,
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
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
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,
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
1 SOGC Clinical Practice Guidelines, J Obstet Gynaecol Can 2003;25(5).
2 Uterine Fibroids. The American College of Obstetricians and
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.
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:
NATIONAL Public Relations
Robert Tessarolo, General Manager
Actavis Specialty Pharmaceuticals Co.