- Topline results from ACHIEVE I (UBR-MD-01) study demonstrate efficacy, safety and tolerability -
- Study meets Co-Primary Endpoints in First of Two Phase 3 Studies -
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
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.
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.
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.
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.
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