Significantly more patients treated with Ubrelvy versus placebo achieved pain freedom two hours post-treatment

TUESDAY, Dec. 24, 2019 (HealthDay News) — Ubrelvy (ubrogepant) tablets have been approved for acute treatment of migraine with or without aura, the U.S. Food and Drug Administration announced Monday.

Ubrelvy is the first in a class of oral calcitonin gene-related peptide receptor antagonists to receive this approval. It is not indicated for preventive treatment. Approval was based on data from two randomized, double-blind, placebo-controlled trials involving 1,439 patients with a history of migraine with or without aura. Patients received the approved doses of Ubrelvy to treat ongoing migraine. Researchers found that compared with patients receiving placebo, a significantly greater percentage of patients receiving Ubrelvy at all doses achieved freedom from pain two hours after treatment and stopped experiencing their most bothersome migraine symptom two hours after treatment.

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Approval was granted to Allergan USA.

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