The field of migraine treatment saw significant advancements in 2024, with new guidelines, FDA approvals, and promising clinical trial results offering hope for improved patient outcomes. These developments span pharmacological and non-pharmacological approaches, addressing both acute and preventive treatment strategies.
CGRP Inhibitors as First-Line Migraine Prevention
In a notable shift, the American Headache Society (AHS) now recommends calcitonin gene-related peptide (CGRP)-targeting therapies as a first-line option for migraine prevention. This recommendation follows a comprehensive review of clinical trial data and real-world experience, leading the AHS to conclude that CGRP inhibitors have become indispensable in migraine prevention due to their efficacy and safety profiles.
Nerivio Approved for Pediatric Migraine
Theranica's Nerivio, a remote electrical neuromodulation (REN) device, received FDA approval for expanded use in pediatric patients aged 8 years and older for the acute treatment of migraine. This needle-free wearable device is the first non-drug therapy cleared for acute migraine in this population and the only prescribed preventive migraine treatment for this age group, offering a valuable alternative to medication.
Satsuma Resubmits NDA for STS101 Nasal Powder
Satsuma Pharmaceuticals has resubmitted its new drug application (NDA) to the FDA for STS101, a dihydroergotamine (DHE) nasal powder, for the acute treatment of migraine with or without aura. This resubmission addresses the concerns raised in a previous complete response letter (CRL), and the company anticipates a positive outcome.
Axsome's AXS-07 Nears Potential Approval
The FDA has accepted Axsome Therapeutics’ resubmitted NDA for AXS-07, an oral, rapidly absorbed, multi-mechanistic investigational medicine for acute migraine. The agency has set a Prescription Drug User Fee Act (PDUFA) action goal date of January 31, 2025.
Digital Therapeutic CT-132 Shows Promise
CT-132 (Click Therapeutics), an investigational prescription digital therapeutic, met its primary endpoint in the Phase 3 ReMMi-D trial (NCT05853900) for episodic migraine prevention. Results demonstrated a significant reduction in monthly migraine days (MMDs) over a 12-week treatment period, suggesting a potential new avenue for migraine management.
Sumatriptan for Post-Traumatic Headache
Preliminary data from a Phase 2 trial (NCT01854385) suggests that sumatriptan, a migraine-specific medication, may alleviate symptoms of post-traumatic headache (PTH). Further research, including a larger Phase 3 trial, is needed to confirm these findings.
Lu AG09222 Targets PACAP for Migraine Relief
The Phase 2 HOPE trial (NCT05133323) published in the New England Journal of Medicine, evaluated Lundbeck’s pituitary adenylate cyclase-activating polypeptide (PACAP)-targeting therapy, Lu AG09222. A single intravenous infusion of 750 mg of Lu AG09222 was superior to placebo in reducing migraine frequency over a 4-week period, supporting its potential as an alternative migraine treatment.
Atogepant Effective in Medication Overuse
Post-hoc data from the Phase 3 PROGRESS trial (NCT03855137) showed that atogepant (Qulipta; AbbVie) was effective in treating chronic migraine, even in patients with acute medication overuse.
