NORTH CHICAGO, Ill.,
Oct. 19, 2016 /PRNewswire/
-- AbbVie (NYSE: ABBV), a global biopharmaceutical company in
cooperation with Neurocrine Biosciences, Inc. (NASDAQ: NBIX), today
announced detailed results from two replicate pivotal Phase 3
clinical trials evaluating the efficacy and safety of Elagolix in
premenopausal women who suffer from endometriosis. The data
demonstrate that, compared to placebo at month three and month six,
patients treated with Elagolix reported statistically significant
reductions in scores for menstrual pain (dysmenorrhea, DYS) and
non-menstrual pelvic pain (NMPP) associated with endometriosis as
measured by the Daily Assessment of Endometriosis Pain scale. The
results were presented at the 72nd American Society for
Reproductive Medicine Scientific Congress & Expo (ASRM) in
Salt Lake City, as well as
additional abstracts.
"Endometriosis is often characterized by chronic pelvic pain,
and can have a significant impact on patient function and quality
of life," said Hugh S. Taylor, M.D.,
study investigator and Chair of the Department of Obstetrics,
Gynecology and Reproductive Sciences, Yale
School of Medicine. "The results presented today are
encouraging for patients and demonstrate that Elagolix has the
potential to be an important treatment option for women suffering
from pain related to endometriosis."
In the two studies, both doses of Elagolix administered orally
demonstrated a statistically significant (p ≤ 0.001) improvement
versus placebo in the percentage of DYS and NMPP responders. In the
first study, at month three, 46 percent of patients treated with
150 mg once daily and 76 percent of patients treated with 200 mg
twice daily of Elagolix were classified as DYS responders, versus
20 percent of patients in the placebo group. Fifty percent of
patients treated with 150 mg once daily and 55 percent of patients
treated with 200 mg twice daily of Elagolix were classified as NMPP
responders, versus 36 percent of patients in the placebo group. The
second pivotal Phase 3 study demonstrated similar results.
"These results from the largest clinical trials ever conducted
in endometriosis support AbbVie's continued efforts to pursue
regulatory filing of Elagolix as a potential new treatment option
for the disease's most prevalent symptoms," said Rob Scott, M.D., Vice President, Development and
Chief Medical Officer, AbbVie. "There have been few recent
scientific advancements for patients suffering from endometriosis
and physicians are in need of additional treatment options to help
manage this chronic and painful disease."
At ASRM, AbbVie will present multiple abstracts highlighting
primary and secondary efficacy and safety endpoint data from the
Phase 3 studies as well as research on the economic burden of
endometriosis and endometriosis-related surgery in women in
the United States. AbbVie plans to
submit a New Drug Application to the U.S. Food and Drug
Administration (FDA) for endometriosis in 2017.
The safety profile of Elagolix was consistent across both Phase
3 trials and also consistent with prior Elagolix studies. In the
first study, the most frequently reported adverse events (AEs)
assessed over six months were hot flush (7%, 24%, 42% for placebo,
150 mg once daily and 200 mg twice daily, respectively), headache
(10%, 15%, 17% for placebo, 150 mg once daily and 200 mg twice
daily, respectively), and nausea (14%, 10%, 16% for placebo, 150 mg
once daily and 200 mg twice daily, respectively). As anticipated by
its mechanism of action, some AEs, such as hot flush were
dose-dependent. The majority of hot flushes (>50%) were mild in
severity. Discontinuations due to AEs were 5.9 percent and 6.1
percent for placebo in study 1 and study 2, respectively, 6.4
percent and 4.4 percent for 150 mg once daily in study 1 and study
2, respectively and 9 percent and 10 percent for 200 mg twice daily
in study 1 and study 2, respectively.
Trial Design
The first pivotal Phase 3 trial (M12-665) was a 24-week,
randomized, double-blind, placebo-controlled study evaluating the
safety and efficacy of Elagolix in 872 women, age 18 to 49, with
moderate-to-severe endometriosis-associated pain. It was conducted
at 175 sites in the United States,
Puerto Rico and Canada. An extension study (M12-667) permitted
some women to be treated for an additional six months with these
doses.
The second pivotal Phase 3 trial (M12-671) employed the same
design as the first pivotal Phase 3 trial, was multinational, and
included 815 women with moderate-to-severe endometriosis-associated
pain across 226 sites in 13 countries (US and 12 ex-US countries).
There was equal representation of enrollment from US and Ex-US
countries. An extension study (M12-821) permitted some women to be
treated for an additional 6 months with these doses. Together,
these two Phase 3 pivotal studies evaluated the safety and efficacy
of Elagolix in nearly 1,700 women with moderate-to-severe
endometriosis associated pain, representing the largest prospective
randomized endometriosis trials conducted to date.
About Endometriosis
Endometriosis occurs when the cells that normally line the
uterus begin to grow outside of the uterus, leading to chronic
pelvic pain, pain with intercourse and heightened pain with
menses.1 These growths are called lesions and can occur
on the ovaries, the fallopian tubes, or other areas near the
uterus, such as the bowel or bladder.2,3 There is no
cure for endometriosis, and the associated pain is currently
managed with oral contraceptives, progestins, danazol, nonsteroidal
anti-inflammatory drugs (NSAIDs), opioids, and GnRH agonists, many
of which are not specifically indicated for the treatment of
endometriosis. In more extensive cases, surgical interventions
(e.g., laparotomy or laparoscopy) are often pursued, and may not be
curative for all individuals.4
About Elagolix
Elagolix, a gonadotropin-releasing hormone (GnRH) receptor
antagonist, is an orally administered, short-acting molecule that
blocks endogenous GnRH signaling by binding competitively to GnRH
receptors in the pituitary gland. Administration results in rapid,
reversible, dose-dependent inhibition of luteinizing hormone (LH)
and follicle-stimulating hormone (FSH) secretion, leading to
reduced ovarian production of the sex hormones, estradiol and
progesterone, while on therapy. Elagolix is currently being
investigated in diseases that are mediated by sex hormones, such as
uterine fibroids and endometriosis. To date, Elagolix has been
studied in over 40 clinical trials totaling more than 3,000
subjects. Phase 3 trials of Elagolix for the management of uterine
fibroids are ongoing.
About AbbVie
AbbVie is a global, research-based biopharmaceutical company
formed in 2013 following separation from Abbott Laboratories. The
company's mission is to use its expertise, dedicated people and
unique approach to innovation to develop and market advanced
therapies that address some of the world's most complex and serious
diseases. Together with its wholly-owned subsidiary, Pharmacyclics,
AbbVie employs more than 28,000 people worldwide and markets
medicines in more than 170 countries. For further information on
the company and its people, portfolio and commitments, please visit
www.abbvie.com. Follow @abbvie on Twitter or view careers on our
Facebook or LinkedIn page.
Forward-Looking Statements
Some statements in this news release may be forward-looking
statements for purposes of the Private Securities Litigation Reform
Act of 1995. The words "believe," "expect," "anticipate," "project"
and similar expressions, among others, generally identify
forward-looking statements. AbbVie cautions that these
forward-looking statements are subject to risks and uncertainties
that may cause actual results to differ materially from those
indicated in the forward-looking statements. Such risks and
uncertainties include, but are not limited to, challenges to
intellectual property, competition from other products,
difficulties inherent in the research and development process,
adverse litigation or government action, and changes to laws and
regulations applicable to our industry. Additional information
about the economic, competitive, governmental, technological and
other factors that may affect AbbVie's operations is set forth in
Item 1A, "Risk Factors," in AbbVie's 2015 Annual Report on Form
10-K, which has been filed with the Securities and Exchange
Commission. AbbVie undertakes no obligation to release publicly any
revisions to forward-looking statements as a result of subsequent
events or developments, except as required by law.
1 Mayo Clinic. Diseases and Symptoms:
Endometriosis Fact Sheet.
http://www.mayoclinic.org/diseases-conditions/endometriosis/basics/symptoms/con-20013968.
Accessed February 1, 2016.
2 MM, Silverberg K, Olive DL. Endometriosis and
Adenomyosis. IN: Copeland LJ, Jarrell JF, eds. Textbook of
Gynecology. 2nd ed. Philadelphia,
PA: WB Saunders; 2000:687-722.
3 The American College of Obstetricians and
Gynecologists. ACOG Education Pamphlet AP013: Endometriosis.
Washington, DC: September 2008. ISSN 1074-8601.
4 Mayo Clinic. Diseases & Conditions:
Endometriosis Fact Sheet.
http://www.mayoclinic.org/diseases-conditions/endometriosis/diagnosis-treatment/treatment/txc-20236449.
Accessed February 1, 2016.
Logo -
http://photos.prnewswire.com/prnh/20160706/386913LOGO
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/abbvie-announces-positive-pivotal-phase-3-data-demonstrating-investigational-medicine-elagolix-reduces-menstrual-and-non-menstrual-pelvic-pain-associated-with-endometriosis-at-the-american-society-for-reproductive-medicine-scienti-300347175.html
SOURCE AbbVie