Trial for novel CGRP migraine medicine gleans positive results

20 November 2023

Catherine Eckford / European Pharmaceutical Review

The first pill designed to directly block calcitonin gene-related peptide (CGRP), a protein released during a migraine attack, has demonstrated positive evidence in AbbVie’s trial investigating its efficacy in the prodrome phase.

Results from AbbVie’s Phase III study, PRODROME, published in The Lancet showed that UBRELVY® (ubrogepant) 100mg for acute treatment of migraine significantly reduced the likelihood of development of moderate or severe headache compared to placebo within 24 hours post-dose.

This was demonstrated when the calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) was administered during the prodrome phase (ie, one to sixurs before the predicted onset of headache pain) of a migraine attack.

Blocking CGRP in migraines

According to AbbVie, UBRELVY is the first pill designed to directly block CGRP, a protein released during a migraine attack, from binding to its receptors.

The small molecule treatment is the first and only acute treatment for migraine that has demonstrated data in the prodrome phase in a Phase III, double-blind, placebo-controlled trial, AbbVie highlighted.

During the Phase III clinical trial, patients with migraine who could identify prodromal symptoms that led to headache at least 75 percent of the time.

AbbVie shared that study results demonstrated:

UBRELVY was well-tolerated with no new safety signals observed when administered during the prodrome, data from the clinical trial found.

“… previously we have not had adequate data for treatment options during this earliest phase,” stated Dr Peter Goadsby, PhD, neurologist and professor at King’s College London. “These new data speak directly to a gap in migraine treatment and the option to use ubrogepant.”



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