FDA Accepts Ubrogepant NDA for Acute Migraine

MARCH 11, 2019
Kevin Kunzmann
FDAThe US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) of ubrogepant as an oral therapy for the acute treatment of migraine.

The NDA, if approved by the FDA in the fourth quarter of 2019, would make the Allergan drug the first oral calcitonin gene-related peptide (CGRP) receptor antagonist approved for acute migraine treatment.

Allergan submitted the NDA with evidence from the results of 4 clinical trials demonstrating the efficacy, safety, and tolerability of ubrogepant—the 2 pivotal studies ACHIEVE I and II, and another 2 safety studies. The trials included a broad patient population that featured those who reported an insufficient response to triptan therapy, or patients contraindicated for triptan. The company also included patients who had moderate to severe cardiovascular risk profiles.

In the pivotal phase 3 ACHIEVE studies, adult patients were administered either 25 mg, 50 mg, or 100 mg ubrogepant, or placebo, to treat single migraine attacks. Patients treated with 50 mg and 100 mg doses met the studies’ co-primary endpoints of statistically significant greater rates of patients with pain freedom and absence of most bothersome symptoms post-two hour initial dose, compared to placebo.

The 2 treatment dose groups also met the key secondary endpoints of a statistically significant greater rates of patients achieving pain relief post-two hour initial dose, compared to placebo.

In the 2 safety trials—a phase 3, multicenter, randomized, 52-week extension study, and a phase 1, multicenter, double-blind, parallel group study—patients demonstrated good tolerance of 50 mg and 100 mg ubrogepant. Frequently reported adverse events included were nasopharyngitis, upper respiratory tract infection and sinusitis. Treatment dosing was not associated with persistent increases in ALT/AST versus placebo.

Jessica Ailani, MD, neurologist and director of the Medstar Georgetown Headache Center, noted that ubrogepant could become the first innovative therapy approved for acute migraine treatment in 25-plus years. She anticipated its use would span across episodic and chronic variations of the condition.

“Despite its prevalence and burden, migraine remains an undertreated disease, with many patients continuing to seek additional treatment options from their physicians," she said in a statement.

David Nicholson, PhD, chief research and development officer for Allergan, said ubrogepant could be used in conjunction with other available migraine therapies, pending its approval.

“In addition to ubrogepant, we are continuing to advance the phase 3 clinical program for atogepant, the company's second orally-administered investigational CGRP receptor antagonist specifically for migraine prevention,” he said.

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