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The Food and Drug Administration (FDA) has accepted the new drug application (NDA) for ubrogepant for acute migraine treatment (Allergan, Madison, NJ) and set a 10-month review period. If approved, ubrogepant i will be the first orally available drug in the class of calcitonin gene-related peptide (CGRP) antagonists.
In the ACHIEVE I study (NCT02828020) 21.2% of patients treated with 100 mg ubrogepant and 19.2% of those treated with 50 mg ubrogepant had pain relief after 2 hours vs 11.8% of patients treated with placebo (P = .0023, P = .0003). Relief from most bothersome symptoms that included sensitivity to light or sound and nausea, was 38.6% and 37.7% for those who took 100 mg or 50 mg ubrogepant vs 27.8% for placebo (P = .023 for both doses).
In pivotal trials, over 1,230 patients treated 21,454 migraine attacks with 31,968 doses of ubrogepant and had minimal adverse events. Additionally, in study 3110-105-002, approximately 500 healthy adults received 2 days of consecutive treatment with 100 mg ubrogepant, alternating with 2 days of placebo, mimicking how episodic migraine is often treated. No treatment-related adverse events were higher with ubrogepant vs placebo, and no hepatic safety issue were seen.
David Nicholson, Chief Research and Development Officer, Allergan said, "as a leader in chronic migraine research for more than 20 years, Allergan looks to provide options for patients who need new acute and preventative treatments for migraine."
"Despite its prevalence and burden, migraine remains an undertreated disease, with many patients continuing to seek additional treatment options from their physicians," said Dr. Jessica Ailani, a neurologist and Director of the Medstar Georgetown Headache Center. "If approved, ubrogepant, the first innovation in the acute treatment of migraine in over 25 years, will be used across the entire spectrum of the disease (from episodic to chronic) helping patients achieve relief in the moments when they most demand it."
Mary Motwani, PhD; and Deena Kuruvilla, MD
Regina Krel, MD; and Paul G. Mathew, MD, DNBPAS, FAAN, FAHS
Niushen Zhang, MD