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10.17.2018 | Investors

Allergan Announces Completion of Two Positive Safety Studies for Ubrogepant - an Oral CGRP Receptor Antagonist for the Acute Treatment of Migraine

--One-year study continues to support positive safety and tolerability profile for ubrogepant--
--Two-month hepatic safety study in healthy volunteers demonstrated no signal of drug-induced liver injury--
--U.S. NDA filing for ubrogepant on track for early 2019--

DUBLIN, Oct. 17, 2018 /PRNewswire/ -- Allergan plc (NYSE: AGN) today announced the completion of two positive safety and tolerability studies of ubrogepant for the acute treatment of migraine. The first study (UBR-MD-04) evaluated the long-term safety and tolerability of ubrogepant (50 mg and 100 mg) compared to usual care for the acute treatment of migraine in adults for one year.The second study (3110-105-002) evaluated the hepatic safety and tolerability of ubrogepant 100 mg compared to placebo in healthy study participants over eight weeks. 

Allergan plc logo (PRNewsFoto/Allergan plc) (PRNewsfoto/Allergan plc)

Based on the completion of these safety studies for ubrogepant and previously reported efficacy and safety results from the ubrogepant ACHIEVE I (UBR-MD-01) and ACHIEVE II (UBR-MD-02). studies, Allergan will  submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) by the first quarter of 2019. Allergan anticipates that the ubrogepant NDA will be the first oral CGRP receptor antagonist submitted in the U.S. for the acute treatment of migraine with or without aura.

Study UBR-MD-04

UBR-MD-04, a multicenter, randomized, open-label extension study, included 1,254 U.S. adult patients (ITT population) with migraine who had been enrolled in and completed one of the previous pivotal studies for ubrogepant: ACHIEVE I or ACHIEVE II. Both 50 mg and 100 mg doses were administered orally to treat up to 8 migraine attacks every 4 weeks for one year. Patients had the option to take a second dose of ubrogepant or rescue medication if the patient had either a nonresponding migraine or a migraine recurrence. This open-label study had a usual care control arm in which patients were instructed to treat their migraine with medication(s) that they routinely used to relieve a migraine attack.

Of the 1,230 patients in the safety population, approximately 76% of patients completed the 52-week treatment period with similar rates of completion across all the groups. Over the course of the study, 21,454 migraine attacks were treated with 31,968 doses of ubrogepant. The mean number of migraine attacks treated over the 52-week period was 25.5 (50 mg) and 27.2 (100 mg). 

In this study, ubrogepant was well tolerated with an adverse event profile similar to usual care arm. The most common adverse events (>5%) were nasopharyngitis, upper respiratory tract infection, sinusitis, urinary tract infection, and influenza. In terms of hepatic safety, no signal of drug-induced liver injury or a hepatic safety concern was observed.

Study 3110-105-002

Study 3110-105-002, a  multi-center, randomized, double-blind, placebo-controlled trial, included 516 healthy participants (adults ages 18 to 50) for a duration of 8 weeks. Study 3110-105-002 was conducted based on FDA recommendations to complete a hepatic safety study. Ubrogepant was administered intermittently (2 days of consecutive treatment with ubrogepant 100 mg, alternating with 2 days of placebo) to reflect the episodic nature of migraine and mimic the way in which patients often experience and treat migraine attacks. Of the 516 participants in the safety population, approximately 90% completed the 8-week treatment period with nearly identical rates of completion across all groups.

In this study, ubrogepant was well tolerated with an adverse event profile similar to placebo. The most common adverse events (>5%) were headache, oropharyngeal pain, and nasopharyngitis. In terms of hepatic safety, no signal of drug-induced liver injury or a hepatic safety concern was observed.

"Allergan remains at the forefront of addressing unmet patient needs among migraine patients by developing new and innovative treatment options," said David Nicholson, Chief Research and Development Officer, Allergan. "We are pleased with the positive results from these two important studies supporting the safety and tolerability of ubrogepant and look forward to filing the NDA for this promising treatment option for adults living with migraine."

"Those with migraine face significant challenges due to their disease. Despite the prevalence of migraine, there remains a need for additional therapeutic options for patients, some of whom are not candidates for currently available treatments," said 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. "Patients deserve new medications to help with their treatment needs and goals."

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 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 leader. 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.

Allergan's success is powered by our 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; risks associated with divestitures, acquisitions, mergers and joint ventures; 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, 2017 and Allergan's Quarterly Report on Form 10-Q for the period ended June 30, 2018. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.

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