Trial for novel CGRP migraine medicine gleans positive results
Posted: 17 November 2023 | Catherine Eckford (European Pharmaceutical Review) | No comments yet
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:
- Absence of moderate or severe intensity headache within 24 hours was achieved following 46 percent of qualifying prodrome events when treated with UBRELVY versus 29 percent of placebo-treated events
- Absence of headache of any intensity within 24 hours was achieved following 24 percent of qualifying prodrome events when treated with UBRELVY vs. 14 percent of placebo-treated events
- Absence of moderate or severe intensity headache within 48 hours was achieved following 41 percent of qualifying prodrome events when treated with UBRELVY versus 25 percent of placebo-treated events
- Compared to placebo, more patients had normal function within the 24 hours after treatment of qualifying prodrome events with UBRELVY.
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.”