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AbbVie (AbbVie) recently announced that the results of its phase 3 clinical trial of the CGRP receptor inhibitor atogepant for the prevention of paroxysmal migraine patients have been published in the New England Journal of Medicine
.
The results of the trial showed that all dose groups of atogepant reached the primary endpoint.
Compared with placebo, the average number of migraine days per month during the 12-week treatment period was significantly reduced
Atogepant, currently under review by the US FDA, is an investigational oral calcitonin gene-related peptide (CGRP) receptor antagonist
.
CGRP and its receptors are expressed in areas of the nervous system related to the pathophysiology of migraine
.
The primary endpoint of the phase 3 clinical trial is the change in the patients' average monthly migraine days during the 12-week treatment period from baseline
.
All atogepant dose groups reached the primary endpoint
.
▲Atogepant molecular structure (picture source: PubChem)
The clinical trial achieved multiple key secondary endpoints at the same time, including a reduction in the number of migraine days per month in the 10 mg, 30 mg, and 60 mg atogepant groups, respectively, during the 12-week treatment period.
50% or more, compared with 29.
0% in the placebo group (all dose groups compared with the placebo group, p<0.
0001)
.
In terms of safety and tolerability, all doses were well tolerated
.
The most common adverse events were constipation (6.
9-7.
(The original text has been deleted)
Reference materials:
[1] New England Journal of Medicine Publishes 12-Week Results from Study Evaluating Atogepant for the Preventive Treatment of Migraine.