- Endometriosis affects up to one in 10 women of reproductive
age in Canada.1
- 7 out of 10 women being managed for endometriosis have
unresolved pain throughout the month.2
MONTREAL, May 21, 2019 /CNW/ - AbbVie (NYSE: ABBV), a
global, research and development-driven biopharmaceutical company,
in cooperation with Neurocrine Biosciences, Inc. (NASDAQ: NBIX),
announced that ORILISSA™ (elagolix) 200 mg twice daily is now
available. ORILISSA is the first and only oral
gonadotropin-releasing hormone receptor (GnRHr) antagonist, for the
treatment of moderate to severe pain associated with
endometriosis.3
"Endometriosis is a misunderstood and often
mismanaged disease. It has been estimated that on average, it
takes 9-10 years for a woman to receive a diagnosis of
endometriosis. This is often because patients themselves and
physicians normalize the pain these patients are experiencing. This
can have a huge impact on their quality of life, relationships and
work productivity. Even diagnosed women who suffer from it
tend to normalize their pain and downplay the effects it has on all
aspects of their lives," says Dr. Jamie Kroft MD, MSc, FRCSC,
Assistant Professor, Minimally Invasive Gynaecologic Surgery, Core
Obstetrics & Gynaecology, Sunnybrook Health Sciences Centre.
"The women I see in my practice always have a lot of questions,
especially around appropriate medical management. I take the time
to explain their options so they can make an informed
decision. Therefore, the more options that are available, for
example ones that are hormone-free and can be customized to my
patients' needs, the better I can treat them. Women should not
suffer in silence, especially not when there are new treatment
advances."
ORILISSA (elagolix) is a novel, orally administered, highly
potent, short-acting, selective, non-peptide small molecule GnRHr
antagonist that blocks endogenous GnRH signaling by binding
competitively to GnRH receptors in the pituitary gland.
Administration of ORILISSA results in dose-dependent suppression of
luteinizing hormone (LH) and follicle-stimulation hormone (FSH)
levels, leading to decreased blood levels of the ovarian sex
hormones, estradiol and progesterone. LH and FSH suppression begins
within hours of administration and is readily reversible upon
discontinuation of ORILISSA.3
"At the Endometriosis Network Canada, we encourage our members
to become informed and empowered. Having an accurate diagnosis and
getting treatment from an endometriosis
expert are important steps in attaining relief from their
symptoms. Although endometriosis is currently incurable, there are
effective treatments available and in partnership with their
healthcare professionals, patients can work on a treatment plan
that works for them. Ultimately, we know what people living with
this debilitating disease want is to live fulfilling and pain-free
lives, where they are able to pursue any endeavour, both
professionally and personally," explains Philippa Bridge-Cook, Ph.D., Executive Director
of The Endometriosis Network Canada.
Endometriosis causes chronic pelvic pain and is sometimes
associated with infertility. It affects up to one in 10 women
of reproductive age in Canada.1 Furthermore, 7 out of 10
women being managed for endometriosis have unresolved pain
throughout the month. 2
The approval of ORILISSA is supported by data from two
replicate studies in the largest endometriosis Phase 3 study
program conducted to date, which evaluated nearly 1,700 women with
moderate to severe endometriosis pain. Clinical trial data
demonstrated ORILISSA significantly reduced the three most common
types of endometriosis pain: dysmenorrhea, non-menstrual pelvic
pain and dyspareunia. A higher proportion of women treated with
ORILISSA 150 mg once daily and 200 mg twice daily were responders
for daily menstrual pain and non-menstrual pelvic pain compared to
placebo in a dose- dependent manner at month three. Women
were defined as responders if they experienced a clinically
meaningful reduction in daily menstrual pain and
non-menstrual pelvic pain with no increase in analgesic
use (nonsteroidal anti-inflammatory drug or opioid) for
endometriosis-associated pain.3
Both ORILISSA treatment groups showed statistically
significant greater mean decreases from baseline compared to
placebo in daily menstrual pain and non-menstrual pelvic pain at
month six. Women in the Phase 3 studies also provided a daily
self-assessment of their endometriosis pain using a numeric rating
scale (NRS) and women taking ORILISSA 150 mg once daily and 200 mg
twice daily reported a statistically (p <0.001) significant
reduction from baseline in NRS scores compared to placebo at
month three. Clinical trial data also demonstrated women taking
ORILISSA 200 mg twice daily showed statistically significant
greater reduction in pain during sexual intercourse from baseline
to month three compared to placebo. The most frequent (≥10%)
adverse reactions reported in clinical trials with ORILISSA
(elagolix) were hot flush, headache and nausea.3
The recommended duration of use for ORILISSA is up to 12months
for the 150 mg once daily dose and up to six months for the
200 mg twice daily dose, as it causes a dose-dependent decrease in
bone mineral density (BMD). BMD loss is greater with increasing
duration of use and may not be completely reversible after stopping
treatment.3
"We are proud to launch the ORILISSA 200 mg strength. With this
dose, we are able to offer physicians the unique ability to
individualize the care of their patients. Women with
endometriosis now have a hormone-free choice that is customizable
based on their unique needs," says Stéphane Lassignardie, General
Manager of AbbVie Canada. "AbbVie is committed to women living with
endometriosis as we strive to fill the unmet medical need by
providing a safe and efficacious treatment."
About AbbVie Care
Canadian women prescribed ORILISSA
will have the opportunity to be enrolled in AbbVie Care, AbbVie's
signature support program. The program is designed to provide a
wide range of customized services including reimbursement and
financial support, pharmacy services, personalized education and
ongoing disease management support throughout their treatment. For
more information, please visit www.abbviecare.ca.
About AbbVie
AbbVie is a global, research and
development-driven biopharmaceutical company committed to
developing innovative advanced therapies for some of the world's
most complex and critical conditions. The company's mission is to
use its expertise, dedicated people and unique approach to
innovation to markedly improve treatments across four primary
therapeutic areas: immunology, oncology, virology and
neuroscience. In more than 75 countries, AbbVie employees are
working every day to advance health solutions for people around
the world. For more information about AbbVie, please visit us
at www.abbvie.ca and www.abbvie.com.
Follow @abbvieCanada and @abbvie on Twitter or
view careers on
our Facebook or LinkedIn page.
About Neurocrine Biosciences, Inc.
Neurocrine
Biosciences, a San Diego based
biopharmaceutical company, is focused on developing treatments for
neurological and endocrine related disorders. The company
discovered, developed and markets INGREZZA® (valbenazine), the
first FDA approved product indicated for the treatment of adults
with tardive dyskinesia, a movement disorder. Discovered and
developed through Phase II clinical trials by Neurocrine, ORILISSA™
(elagolix), the first FDA-approved oral medication for the
management of endometriosis with associated moderate to severe pain
in over a decade, is marketed by AbbVie as part of a collaboration
to develop and commercialize elagolix for women's health.
Neurocrine's clinical development programs include opicapone as an
adjunctive therapy to levodopa/DOPA decarboxylase inhibitors
in Parkinson's disease patients, elagolix for uterine fibroids
with AbbVie, valbenazine for the treatment of Tourette syndrome,
and NBI-74788 for the treatment of congenital adrenal hyperplasia
(CAH). For more information and the latest updates from Neurocrine,
please visit www.neurocrine.com.
1
|
YourPeriod.ca.
https://www.yourperiod.ca/endometriosis/what-is-endometriosis/.
Accessed May 2019.
|
2
|
De Graaff AA,
D'Hooghe TM, Dunselman GAJ, Dirksen CD, Hummelshoj L, WERF EndoCost
Consortium, Simoens S. The significant effect of endometriosis on
physical, mental and social wellbeing: results from an
international cross-sectional survey. Hum Reprod.
2013;28(10):2677-2685.
|
3
|
Orilissa Product
Monograph, AbbVie Corporation, October 4, 2018.
http://www.abbvie.ca/content/dam/abbviecorp/ca/en/docs/ORILISSA_PM_EN.PDF.
Accessed May 2019.
|
SOURCE AbbVie