As part of NeurologyLive®'s Year in Review, take a look at our top news articles in headache and migraine in 2023.
In 2023, the NeurologyLive® staff was kept on its toes while covering clinical news and data readouts from around the world across a number of key neurology subspecialty areas. Between major study publications and FDA decisions, and from societal conference sessions and expert interviews, the team spent all year bringing the latest updates to the website's front page.
Among our key focus areas is headache and migraine, two of the most common neurological diseases worldwide. Treatments for headaches have advanced over the years; however, providing lasting and effective treatment for all headache types has proven to be difficult for all practitioners. The field has been advanced significantly by the introduction of calcitonin gene-related peptide (CGRP)-targeting inhibitors, a class of highly effective and safe agents. Whatever the reason for the attention these stories got, their place here helps provide an understanding of the themes in this field over the course of 2023.
Here, we'll highlight some of the most-read content on NeurologyLive® this year. Click the buttons to read further into these stories.
Earlier this year, the FDA approved IntelGenx/Gensco's rizatriptan benzoate (Rizafilm VersaFilm) oral thin film for acute migraine treatment through the 505(b)(2) new drug application (NDA) pathway. This newly approved treatment is an orally disintegrating film formulation of the 5-HT1 receptor agonist designed to be bioequivalent to Merck’s Maxalt-MLT, an orally disintegrating rizatriptan treatment.
The FDA has expanded the indication for atogepant (Qulipta; AbbVie) to include the prevention of chronic migraine in adults, adding to its existing indication for episodic migraine, according to an announcement from AbbVie.1 The approval was granted based on data from the phase 3 PROGRESS trial (NCT03855137) that showed that 60-mg atogepant resulted in a significant reduction in mean monthly migraine days (MMDs) compared with placebo across 12 weeks of treatment.
Using a cohort of medically-insured individuals in Arizona, findings from a recently conducted analysis showed specific factors associated with receiving a migraine diagnosis vs a headache diagnosis. Those in the migraine cohort tended to be middle aged, female, White race, non-Hispanic ethnicity, and have English as their primary language. All told, issues within the social determinants of health categories of family unit dynamics (OR, 1.1; 95% CI, 1.06-1.14) and income and social protection (OR, 1.13; 95% CI, 1.08-1.18) were associated with a higher odds of being in the migraine vs headache cohort.
Findings from a pilot study (NCT04437199) assessing up to 60 g/day of tricaprilin (Cerecin), an investigational ketogenic compound, suggested potential benefit in treating patients with migraine. At the end of the 3-month treatment period, some patients opted to enter the Compassionate Access Program, which provides continued access to the therapy for up to 1 year after completion of the clinical study.
According to a new update from WL Gore & Associates, also known as Gore, patients in the RELIEF clinical study (NCT04100135) have completed their multi-month enhanced screening process and have begun entering the final randomization phase. The trial, initiated in November 2022, assesses whether closing the patent foramen ovale (PFO) using the GORE CARDIOFORM Septal Occluder may provide relief for patients with migraine. The GORE CARDIOFORM Septal Occluder is a permanently implanted device indicated for the percutaneous, transcatheter closure of ostium secundum atrial septal defects (ASDs) and PFO, intended to reduce the risk of recurrent ischemic stroke.
At the 2023 International Headache Congress, held September 14-17, in Seoul, Korea, new data from the phase 2 HOPE trial (NCT05133323) highlighted the effects of Lu AG09222 (Lundbeck), a pituitary adenylate cyclase-activating polypeptide (PACAP)-targeting agent, as a potential preventive for migraine. All told, the trial met its primary end point, with significant between-group differences observed in the high dose group of treated patients over a 12-week double-blind period.
The European Commission approved AbbVie’s atogepant (Aquipta) for the prophylaxis of migraine in adults who have 4 or more migraine days per month, becoming the first and only calcitonin gene-related peptide (CGRP) agent indicated for prevention of both episodic and chronic migraine. The approval was based on data from 2 phase 3 studies, PROGRESS (NCT03855137) and ADVANCE (NCT02848326), in which atogepant-treated patients showed greater reduction of monthly migraine days (MMDs) than placebo.
Investigators published full findings of the phase 3 PRODROME study (NCT04492020) demonstrating ubrogepant’s (Ubrelvy; AbbVie) positive impact on migraine during the prodrome phase in The Lancet. At the conclusion of the trial, absence of moderate or severe headache within 24 hours after initiating treatment occurred in 46% (190 of 418) of qualifying prodrome events that had been treated with ubrogepant compared with 29% (121 of 423) of events treated with placebo (OR, 2.09; 95% CI, 1.63-2.69; P <.0001).
Newly announced topline findings from the CHALLENGE-MIG trial (NCT05127486), the first head-to-head clinical study comparing 2 medications targeting calcitonin gene-related peptide (CGRP), revealed similar efficacy between galcanezumab (Emgality; Eli Lilly) and rimegepant (Nurtec ODT; Biohaven Pharmaceuticals). Despite this, galcanezumab outperformed Rimegepant on secondary end points at the end of the 3-month trial.
The FDA has accepted Satsuma Pharmaceuticals’ 505(b)(2) new drug application (NDA) for its novel, investigational dihydroergotamine (DHE) nasal powder product, STS101, for the acute treatment of migraine. The agency is expected to make a decision on the therapy by January 2024. STS101 is designed to provide significant benefits vs existing acute treatments for migraine, including the combination of quick and convenient self-administration and other clinical advantages that current DHE liquid nasal spray products and injectable dosage forms lack.