Allergan Announces Positive Phase 3 ACHIEVE I Trial Results for Ubrogepant Published in The New England Journal of Medicine
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
About ACHIEVE I (UBR-MD-01) and ACHIEVE II (UBR-MD-02)
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™
About Allergan plc
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.
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