Allergan Announces Positive Phase 3 ACHIEVE I Trial Results for Ubrogepant Published in The New England Journal of Medicine
"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
The ACHIEVE I trial evaluated ubrogepant 50 mg and 100 mg, compared with placebo, across a wide range of endpoints, including more stringent
"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
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
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
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 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.
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.
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.
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.
With colleagues and commercial operations located in approximately 100 countries,
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