DUBLIN, Dec. 4, 2019 /PRNewswire/ -- Allergan
plc (NYSE: AGN) today announced that positive results from ACHIEVE
I (UBR-MD-01), a robust Phase 3 clinical trial evaluating the
efficacy, safety and tolerability of ubrogepant, have been
published in the December
5th issue of The New England Journal of
Medicine (NEJM). The data from this second published
pivotal trial reinforced that the acute treatment of migraine with
ubrogepant, compared with placebo, led to significantly greater
rates of pain freedom and freedom from the most bothersome
migraine-associated symptom at two hours with both the 50 mg and
100 mg doses. If FDA-approved, ubrogepant would be the first
available and approved small molecule, oral calcitonin
gene-related peptide (CGRP) receptor antagonist (gepant) for the
acute treatment of migraine.
"The findings from the ACHIEVE I trial are particularly
meaningful for primary care physicians who are first-line in
migraine management and need treatment options that are safe and
effective to treat debilitating migraine symptoms," said
Susan Hutchinson, MD, Family
Practice Headache Specialist and Founder of Orange County Migraine
& Headache Center and paid consultant for Allergan. "With
limited migraine-specific acute treatment options on the market,
the approval of ubrogepant would provide healthcare providers and
patients a much-needed new treatment option with a favorable
side-effect profile that can be taken on-demand to effectively
treat a migraine attack."
The ACHIEVE I trial evaluated ubrogepant 50 mg and 100 mg,
compared with placebo, across a wide range of endpoints, including
more stringent FDA guidelines established in 2018 for the acute
treatment of migraine: meeting both co-primary endpoints of pain
freedom (no pain at all) and freedom from the most bothersome of
three non-headache migraine-associated symptoms (no sensitivity to
light, no sensitivity to sound, or no nausea at all) at two hours
post initial dose. For the two co-primary endpoints, ubrogepant 50
mg and 100 mg showed statistically significant higher response
rates for pain freedom at two hours (11.8% for placebo, 19.2% for
50 mg, 21.2% for 100 mg) and freedom from the most bothersome
migraine-associated symptom at two hours (27.8% for placebo, 38.6%
for 50 mg, 37.7% for 100 mg).
"Based on the recently published ACHIEVE I and ACHIEVE II data,
I am confident that ubrogepant, with its novel mechanism of action
as a gepant, will make a difference for people with migraine and
unmet needs for acute treatment," said Richard B. Lipton, M.D., Author of ACHIEVE I and
Lead Author of ACHIEVE II, Professor and Vice Chair of Neurology at
the Albert Einstein College of Medicine and Montefiore Health
System, Director of the Montefiore Headache Center. "The favorable
safety and tolerability profile, as well as the efficacy data, for
ubrogepant are particularly important as we consider new treatment
options for people living with migraine." Dr. Lipton is also a paid
consultant for Allergan, the trial sponsor.
Both doses of ubrogepant at 50 mg and 100 mg demonstrated
significant improvement compared with placebo for a secondary
efficacy endpoint of pain relief at two hours (49.1% for placebo,
60.7% for 50 mg, 61.4% for 100 mg). Pain relief was defined as the
reduction in headache severity from moderate to severe pain to mild
or no pain at two hours after initial doses. This secondary
endpoint is most similar to the primary endpoint that older
migraine treatments like triptans demonstrated for FDA approval.
Additionally, both doses of ubrogepant were statistically superior
to placebo in sustained pain relief from two to 24 hours (20.8% for
placebo, 36.3% for 50 mg, 38.0% for 100 mg).
Both the 50 mg and 100 mg doses of ubrogepant were well
tolerated with an adverse event profile similar to placebo. There
were no serious adverse events. Nausea was the most common adverse
event, reported at 1.6% for placebo, 1.7% for 50 mg, 4.1% for 100
mg. Rates of all treatment-emergent adverse events were also
similar to placebo (12.8% in placebo, 9.4% for 50 mg, 16.3% in
100mg).
"I have been living with migraine attacks for more than 20
years, but unfortunately I do not have any tolerable prescription
treatment options to take when I start having pain," said
Anna Williams, migraine patient. "I
am hopeful for new treatment options that will eliminate my
debilitating pain along with other migraine symptoms."
Triptans are by far the most commonly used prescription
medications for migraine, representing 73% of prescriptions within
the acute treatment market. However, for people living with
migraine, 67% report delaying or avoiding taking their prescription
medication when a migraine attack occurs, often because of the
adverse events they experience from the treatment. In addition,
approximately 20% people with migraine have cardiovascular (CV)
disease, and because triptans constrict blood vessels, they may be
contraindicated in this patient population. For those who take
triptans, as many as 30% may not sufficiently respond or may
experience side effects.
"We are pleased to see the results from our pivotal Phase 3
trial published in The New England Journal of Medicine,"
said Mitchell Mathis, M.D., VP,
Chief Medical Officer, Central Nervous System. "With the ACHIEVE II
trial results recently published in The Journal of the American
Medical Association, the recognition from these two prestigious
medical journals underscores the significance of ubrogepant as a
promising oral option for the acute treatment of migraine. We are
proud of the research and science that have brought us to this
point and look forward to continuing innovation in the pursuit of
migraine freedom."
The full NEJM article is available at
http://bit.ly/2qWuI4R
About ACHIEVE I (UBR-MD-01) Study
The ACHIEVE I trial
is a Phase 3, multicenter, double-blind, parallel-group, study
evaluating the efficacy, safety, and tolerability of ubrogepant (50
mg and 100 mg) compared to placebo for the acute treatment of a
single migraine attack of moderate or severe headache pain
intensity. In this pivotal trial, 1,672 adult participants (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. The co-primary efficacy parameters were pain freedom (no
pain) at two hours after the initial dose and freedom from the most
bothersome migraine-associated symptom at two hours after the
initial dose. The most bothersome migraine-associated symptom could
include photophobia, phonophobia, or nausea and was selected by the
participant immediately prior to treating a qualifying migraine
attack. Secondary efficacy endpoints also evaluated the clinical
benefits of ubrogepant across a wide range of outcome measures,
including pain relief at two hours, sustained pain relief from 2 to
24 hours, and sustained pain freedom from 2 to 24 hours, among
others. Adverse events were collected and evaluated for 48 hours
after the initial and optional second dose of trial treatment, as
well as within 30 days after administration of any dose.
About ACHIEVE I (UBR-MD-01) and ACHIEVE II
(UBR-MD-02)
ACHIEVE I and ACHIEVE II both tested the
efficacy of ubrogepant to treat a single migraine attack. The
protocols for the two trials were identical except for the doses of
ubrogepant tested. ACHIEVE I tested doses of 50 mg and 100 mg
versus placebo, whereas ACHIEVE II tested doses of 25 mg and 50 mg
versus placebo.
About Ubrogepant
Ubrogepant is a novel, highly potent,
orally-administered CGRP receptor antagonist (gepant), 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
completely new mechanism of action for the acute treatment of
migraine compared to medications currently available, which include
triptans (serotonin 1B/1D receptor
agonists), opioids, ergots as well as over-the-counter medications,
such ibuprofen and acetaminophen.
About Migraine
Migraine is a chronic disease with episodic attacks defined by
neurological symptoms such as headache pain, sensitivity to light
and sound, and nausea. Migraine is highly prevalent, affecting
approximately 31 million Americans, and is associated with
significant disability leading to high personal, family,
occupational, societal, and economic burden. Based on the current
standard of care, there are still unmet needs for new acute
treatments for migraine.
Allergan, a leader in the migraine space, markets
BOTOX® (onabotulinumtoxinA), the first FDA-approved,
preventive treatment for adult Chronic Migraine (approved 2010).
Allergan is also advancing its migraine program with two
investigational small molecule oral calcitonin gene-related peptide
(CGRP) receptor antagonists (gepants), one of which is being
developed for the acute treatment of migraine and one for the
prevention of migraine. In addition to ubrogepant, which is
expected to be the first FDA-approved gepant with a completely new
approach for acute treatment of migraine, atogepant is currently in
Phase 3 development for the prevention of migraine.
About Allergan MIND™
As part of Allergan's ongoing commitment to innovating
and inspiring change in the migraine community, the company has
established a migraine franchise, Allergan MIND™ (Migraine:
Innovation, Navigation, Discovery), to drive progress and
unify its efforts as a worldwide leader in migraine. Allergan
MIND™ represents the company's vision and mission to continue
advancing science and improving the lives of people living with
migraine with treatments, education and support in the pursuit of
migraine freedom. This new migraine franchise serves as a center of
excellence and catalyst for advancing the dialogue and treatment
landscape in migraine, bringing together diverse stakeholders to
rally around the latest insights and developments that will impact
the future of migraine.
About Allergan plc
Allergan plc (NYSE: AGN),
headquartered in Dublin, Ireland,
is a global pharmaceutical leader 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 primarily focused on four key
therapeutic areas including medical aesthetics, eye care, central
nervous system and gastroenterology. As part of its approach to
delivering innovation for better patient care, Allergan has built
one of the broadest pharmaceutical and device research and
development pipelines in the industry.
With colleagues and commercial operations located 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; risks associated with
divestitures, acquisitions, mergers and joint ventures; risks
related to impairments; uncertainty associated with financial
projections, projected cost reductions, projected debt reduction,
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, 2018
and Allergan's Quarterly Report on Form 10-Q for the period ended
September 30, 2019. Except as
expressly required by law, Allergan disclaims any intent or
obligation to update these forward-looking statements.
CONTACTS: Allergan:
Investors:
Manisha Narasimhan, PhD
(862) 261-7162
Media:
Lisa Brown
(862) 261-7320
Julie Ciardiello
(732) 429-4909
View original content to download
multimedia:http://www.prnewswire.com/news-releases/allergan-announces-positive-phase-3-achieve-i-trial-results-for-ubrogepant-published-in-the-new-england-journal-of-medicine-300969502.html
SOURCE Allergan plc