Allergan’s positive phase 3 trial results indicate a potential use for the CGRP receptor agonist.
Results from a phase 3 clinical trial evaluating the efficacy, safety, and tolerability of ubrogepant, published in the New England Journal of Medicine (NEJM), indicate that the treatment may significantly reduce rates of migraine pain and associated symptoms.
Ubrogepant is a novel, highly potent, orally administered CGRP receptor antagonist (gepant) currently in development by Allergan. According to an official release, antagonism of the CGRP receptors expressed in regions of the nervous system associated with migraine pathophysiology is a new mechanism of action for the acute treatment of migraine compared to other medications currently available.
Results from a phase 3, multicenter, double-blind, parallel-group study posted today show that a higher percentage of participants receiving ubrogepant had freedom from pain and an absence of their self-reported most bothersome symptom at 2 hours after their initial dose.
In ACHIEVE (UBR-MD-01), the safety, efficacy, and tolerability of ubrogepant 50 mg and 100 mg doses were compared to placebo for the acute treatment of a single migraine attack of moderate or severe headache pain intensity in 1,671 adult participants between the ages of 18 and 75.
Pain Freedom (no pain) at two hours post initial dose
Freedom from most bothersome migraine-associated symptom (photophobia, phonophobia, or nausea as selected by participant) at two hours post initial dose
Secondary efficacy endpoints for this study included the clinical benefits of ubrogepant across various outcome measures included 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 reported and evaluated 48 hours after the initial and optional second doses of trial treatment, and within 30 days after administration of any dose included nausea, somnolence, and dry mouth. Adverse events were reported in 9.4% of the 50mg ubrogepant participants, 16/3% of the 100 mg ubrogepant participants and 12.8% of the participants receiving placebo treatment. According to the authors, these events were more frequent tin the 100-mg ubrogepant group (2.1%-4.1% of those participants).
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Serious adverse events reported within 30 days of the ubrogepant groups included appendicitis, spontaneous abortion, pericardial effusion, and seizure. The authors say that none of these events occurred within 48 hours after initial dose.
Study authors say that further trials are necessary to determine the durability and safety of ubrogepant for acute migraine treatment, as well as its effectiveness compared to other treatments for migraine.