DUBLIN, Feb. 6, 2018 /PRNewswire/ -- Allergan
plc, (NYSE: AGN), a leading global pharmaceutical company today
announced positive results from ACHIEVE I (UBR-MD-01), the first of
two pivotal phase 3 clinical trials evaluating the efficacy, safety
and tolerability of orally administered ubrogepant 50 mg and
ubrogepant 100 mg compared to placebo in a single migraine attack
in adults.
The ACHIEVE I study included 1327 U.S. adult patients (modified
ITT population) randomized (1:1:1) to placebo, ubrogepant 50 mg and
100 mg respectively, who were treated for a single migraine attack
of moderate to severe headache intensity. Both doses showed a
statistically significant greater percentage of ubrogepant patients
achieving pain freedom at 2 hours after the initial dose as
compared to placebo patients (50 mg vs placebo, p=0.0023, 100 mg vs
placebo, p=0.0003) and a statistically significant greater
percentage of ubrogepant patients achieving absence of the most
bothersome migraine-associated symptom at 2 hours after the initial
dose as compared to placebo patients (50 mg vs placebo, p=0.0023,
100 mg vs placebo, p=0.0023). (See Table)
Table: Co-Primary Endpoints Met For Each Ubrogepant Dose vs
Placebo
1 Most Bothersome Symptoms including Photophobia,
Phonophobia or Nausea.
"We are pleased with the favorable results of our ACHIEVE I
study, which support the efficacy, safety, and tolerability profile
of ubrogepant. We are confident that ubrogepant, an oral calcitonin
gene-related peptide (CGRP) receptor antagonist will be an option
for the treatment of migraines in adults," said David
Nicholson, Chief Research and Development Officer, Allergan.
"Allergan remains committed to identifying, developing and bringing
to market therapies that address unmet need for patients suffering
from this debilitating disease."
Ubrogepant was well tolerated with an adverse event profile
similar to placebo. The most common adverse events were nausea,
somnolence, and dry mouth, none of which were reported with a
frequency of ≥5%. In terms of hepatic safety, across all
treatment arms including placebo, there were 6 cases with
aminotransferase (ALT or AST) elevations greater than 3 times the
upper limit of normal (ULN); there were alternative explanations in
all cases (concomitant illness or medication) and none were noted
by the liver safety adjudication board to have a probable
relationship to ubrogepant. There were no cases of Hy's
Law.
"Despite the prevalence of migraine and availability of several
treatment options, the disease remains underdiagnosed and
undertreated. There is also low persistence and adherence to the
current standard of care treatments," said lead investigator Dr.
Richard B. Lipton, Vice Chair of
Neurology, Professor of Epidemiology and Population Health and
Director of the Montefiore Headache Center, all at the Albert
Einstein College of Medicine. "There remains a need for new
treatments with improved benefit-risk profiles. Results from this
ubrogepant phase 3 trial are important in progressing the research
and developing therapies to help migraine patients."
Additional results from this study are anticipated to be
released at upcoming scientific meetings throughout 2018.
Results of the second phase 3 trial, ACHIEVE II (UBR-MD-02), are
expected in the 1st half of 2018. Allergan anticipates filing
of a New Drug Application (NDA) to the FDA in 2019.
About ACHIEVE I (UBR-MD-01) Study
The ACHIEVE I trial
is a Phase 3, multicenter, randomized, double-blind,
placebo-controlled, parallel-group study to evaluate the efficacy,
safety, and tolerability of 2 doses of ubrogepant (50 mg and 100
mg) compared to placebo for the treatment of a single migraine
attack. The modified ITT population included 1327 adult patients
18-75 years of age with a history of migraine (with or without
aura) were randomized (1:1:1) to placebo, ubrogepant 50 mg, or
ubrogepant 100 mg and treated a single migraine attack of moderate
or severe headache pain intensity at home. The co-primary
efficacy parameters were pain freedom (PF) at 2 hours after the
initial dose (defined as a reduction in headache severity from
moderate/severe at baseline to no pain at 2 hours after the initial
dose) and absence of the most bothersome migraine-associated
symptom (photophobia, phonophobia or nausea) at 2 hours after the
initial dose.
About Ubrogepant
Ubrogepant is a novel, highly
potent, orally-administered CGRP receptor antagonist in development
for the acute treatment of migraine. CGRP and its receptors are
expressed in regions of the nervous system associated with migraine
pathophysiology. CGRP receptor antagonism is a novel mechanism of
action for the acute treatment of migraine that clearly differs
from the mechanisms of currently available triptans (serotonin
1B/1D agonists) and
opioids.
About Migraine
Migraine is a chronic disease with
episodic attacks defined by neurological symptoms such as headache
pain, sensitivity to light, sound, and nausea that are often
incapacitating. It is highly prevalent, affecting
approximately 1 in 7 individuals, and is associated with
significant disability leading to societal and economic burden. The
current standards of care in the acute treatment of migraine are
not optimal for many patients' due to partial effectiveness, poor
tolerability, or contraindications. As a consequence, patients
may experience repeated, uncontrolled attacks leading to medication
overuse and increased risk of migraine disease progression. There
is a need for new treatments for migraine with improved
benefit-risk profiles as compared to current standard of care.
Allergan, a leader in the Chronic Migraine space, markets
BOTOX® (onabotulinumtoxinA) the first and only
FDA-approved, preventive treatment for adult Chronic Migraine
patients since it was approved in 2010. Allergan is also advancing
its migraine program with two investigational small molecule oral
calcitonin gene-related peptide (CGRP) receptor antagonists, which
are being developed for the treatment and prevention of migraine.
Allergan's CGRP receptor antagonists, ubrogepant in Phase III for
the acute treatment of migraine and atogepant in Phase IIB for the
prevention of migraine, are expected to be the first oral CGRP
receptor antagonists to market.
About Allergan plc
Allergan plc (NYSE: AGN),
headquartered in Dublin, Ireland,
is a bold, global pharmaceutical company and a leader in a new
industry model – Growth Pharma. Allergan is focused on
developing, manufacturing and commercializing branded
pharmaceutical, device, biologic, surgical and regenerative
medicine products for patients around the world.
Allergan markets a portfolio of leading brands and best-in-class
products for the central nervous system, eye care, medical
aesthetics and dermatology, gastroenterology, women's health,
urology and anti-infective therapeutic categories.
Allergan is an industry leader in Open Science, a model of
research and development, which defines our approach to identifying
and developing game-changing ideas and innovation for better
patient care. With this approach, Allergan has built one of the
broadest development pipelines in the pharmaceutical industry with
55+ mid-to-late stage pipeline programs currently in
development.
Allergan's success is powered by our more than 18,000 global
colleagues' commitment to being Bold for Life. Together, we build
bridges, power ideas, act fast and drive results for our customers
and patients around the world by always doing what is right. With
commercial operations in approximately 100 countries, Allergan is
committed to working with physicians, healthcare providers and
patients to deliver innovative and meaningful treatments that help
people around the world live longer, healthier lives every day. For
more information, visit Allergan's website
at www.Allergan.com.
Forward-Looking Statement
Statements contained in
this press release that refer to future events or other
non-historical facts are forward-looking statements that reflect
Allergan's current perspective on existing trends and information
as of the date of this release. Actual results may differ
materially from Allergan's current expectations depending upon a
number of factors affecting Allergan's business. These factors
include, among others, the difficulty of predicting the timing or
outcome of FDA approvals or actions, if any; the impact of
competitive products and pricing; market acceptance of and
continued demand for Allergan's products; the impact of uncertainty
around timing of generic entry related to key products, including
RESTASIS®, on our financial results; uncertainty
associated with financial projections, projected cost reductions,
projected synergies, restructurings, increased costs, and adverse
tax consequences; difficulties or delays in manufacturing; and
other risks and uncertainties detailed in Allergan's periodic
public filings with the Securities and Exchange Commission,
including but not limited to Allergan's Annual Report on Form 10-K
for the year ended December 31, 2016
and Allergan's Quarterly Report on Form 10-Q for the period ended
September 30, 2017. Except as
expressly required by law, Allergan disclaims any intent or
obligation to update these forward-looking statements.
CONTACTS:
Allergan:
Investors:
Daphne
Karydas
(862) 261-8006
Media:
Mark Marmur
(862) 261-7558
Lisa Brown
(862) 261-7320
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