Lasmiditan, at higher doses, was found to be more effective than rimegepant and ubrogepant for treating acute migraine attacks, though it was linked to higher odds of adverse events, according to a study published in Cephalalgia.

To investigate the efficacy of newer migraine agents, the researchers conducted a random-effects network meta-analysis that included 7 studies involving nearly 13,000 patients. The trials included were phase 3 studies that examined lasmiditan, a serotonin (5-HT) 1F receptor agonist, and rimegepant and ubrogepant, both calcitonin gene-related peptide receptor antagonists, as acute treatments for migraine.

Findings showed that all 3 medications were superior to placebo on the coprimary endpoints of 2-hour pain freedom and freedom from the most bothersome migraine symptom (MBS) associated with migraine attack. Treatment with higher dose lasmiditan (100mg and 200mg) was found to be more effective than rimegepant (75mg) and ubrogepant (50mg or 100mg) with respect to 2-hour pain freedom, while freedom from MBS was achieved equally by all 3 interventions.

Compared with rimegepant and ubrogepant, lasmiditan was associated with greater odds of treatment-emergent adverse events including dizziness, nausea, and somnolence. Of the 3 medications, ubrogepant 50mg was ranked best for tolerability.

“Rimegepant 75mg and ubrogepant 50 and 100mg present good efficacy and a favorable tolerability profile, albeit lower odds of achieving complete pain freedom,” the authors concluded. They noted that the findings should be interpreted cautiously due to the lack of head-to-head comparisons. 

Disclosure: Multiple study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

Reference

Puledda F, Younis A, Tassorelli C, et al. Efficacy, safety and indirect comparisons of lasmiditan, rimegepant, and ubrogepant for the acute treatment of migraine: A systematic review and network meta-analysis of the literature. Published online February 14, 2023. Cephalalgia. doi.org/10.1177/03331024231151419

Treatment with atogepant resulted in a statistically significant reduction in mean monthly migraine days in patients with episodic migraine who previously failed 2 to 4 classes of oral prophylactic treatments, according to data presented at the 2023 American Academy of Neurology Annual Meeting.

Atogepant (Qulipta^®), an oral calcitonin gene-related peptide (CGRP) receptor antagonist, is currently approved by the Food and Drug Administration for the preventive treatment of migraine in adults. The ELEVATE study (ClinicalTrials.gov Identifier: NCT04740827) was conducted to assess the effectiveness of the treatment in patients with episodic migraine who failed oral migraine prophylaxis medications from 2 to 4 medication classes. A total of 309 patients were enrolled in the study; 56% had previously failed 2 classes of medications and 44% had failed 3 or more classes.

Study participants were randomly assigned to receive atogepant 60mg once daily or placebo. The primary endpoint was the change from baseline in mean monthly migraine days (MMDs) across the 12-week treatment period.

Results showed that patients treated with atogepant 60mg once daily experienced a significant decrease in MMDs of 4.20 days compared with a reduction of 1.85 days with placebo (P <.0001). Atogepant was also associated with significant improvement in all secondary endpoints including achievement of more than 50% reduction in MMDs, change from baseline in MMDs, and change from baseline in acute medication use days across 12 weeks. The most commonly reported adverse events that occurred with greater frequency in the atogepant arm included constipation and nausea.

“We understand that people living with migraine endure a chronic neurological disease and we are dedicated to providing them the best chance to live a life with less frequent migraines,” said Dawn Carlson, vice president, neuroscience development, AbbVie. “The data presented at AAN underscores the important role of atogepant, not only as a treatment option for people living with episodic migraine but also for those whose previous treatments failed to help reduce the impact of migraine on their lives.”

(HealthDay News) — COVID-19 infection and vaccination have a negligible effect on migraine worsening, despite patient reports of migraine worsening, according to a study published online Oct. 4 in the European Journal of Neurology.

Laura Melgarejo, from the Vall d’Hebron Hospital in Barcelona, Spain, and colleagues examined the link between COVID-19 infection and COVID-19 vaccination with migraine worsening and its associated factors. Migraine patients who were followed up in a Spanish Headache Clinic received an online survey, which collected information relating to COVID-19 infection and vaccination. Data were also extracted from participants’ electronic diaries (e-diaries), including 1-month data before and after reported infection and/or vaccination.

Of 550 participants, 44.9% and 83.3% reported having had COVID-19 at least once and had been vaccinated, respectively. The researchers found that 61 and 52 patients reported migraine worsening since COVID-19 and vaccination, respectively.

In the 2 settings (infection and vaccination), increased concern about migraine worsening was a risk factor for perceived migraine worsening (odds ratios, 2.498 and 17.3 for infection and vaccination, respectively). Based on e-diary information, available for 136 of the 550 patients, there was no significant difference noted in the frequency of headache before and after infection or vaccination, including on comparison of those with and without self-reported migraine worsening.

“We believe that clinicians should deliver to patients a more reassuring message that COVID-19 and COVID-19 vaccines may only marginally affect migraine course and that the impact of the infection and vaccines is probably smaller than that caused by the patient’s individual rhythmicity of migraine attacks,” the authors write.

Several authors disclosed ties to the pharmaceutical industry.

Abstract/Full Text

The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for STS101 (dihydroergotamine [DHE] nasal powder) for the acute treatment of migraine.

STS101 is an investigational DHE nasal powder product that is administered via a proprietary nasal delivery device. The Company believes that the dry powder DHE formulation will provide fast absorption and robust efficacy compared with existing DHE products. Dihydroergotamine is currently available in an injectable formulation and as a nasal spray.

The NDA is supported by data from a long-term, open-label, phase 3 trial (ClinicalTrials.gov Identifier: NCT04406649), which included 446 adults with at least a 1 year history of migraine with or without aura. A total of more than 10,500 doses of STS101 were administered to treat more than 9000 migraine attacks for up to 18 months. Treatment-emergent adverse events reported during the trial included nasal discomfort and dysgeusia, which were typically mild and transient.

The application also included data from the double-blind, placebo-controlled phase 3 SUMMIT trial (ClinicalTrials.gov Identifier: NCT04940390). While the primary outcome results were not considered statistically significant, treatment with STS101 demonstrated robust and sustained effects on freedom from pain and freedom from most bothersome symptom at all post-dose timepoints after 2 hours (3, 4, 6, 12, 24 and 48 hours).

A regulatory decision is expected in January 2024.

Scilex Holding Company has announced the relaunch of Elyxyb (celecoxib oral solution) for the treatment of acute migraine with or without aura in adults.

Elyxyb is a ready-to-use oral solution formulation of celecoxib, a nonsteroidal anti-inflammatory drug (NSAID). It is formulated using a self-microemulsifying drug delivery system that improves solubility and bioavailability leading to faster absorption. Following administration of 120mg of Elyxyb under fasting conditions, the median time to peak concentration (T_max) was observed to be 1 hour (range, 0.67-3.00).

Elyxyb was originally approved by the Food and Drug Administration (FDA) in May 2020 based on data from 2 double-blind, placebo-controlled trials (ClinicalTrials.gov Identifier: NCT03009019, NCT03006276) that included patients with a history of episodic migraine (2 to 8 migraine attacks per month, with no more than 14 headache days per month, and with 48 hours of headache-free time between migraine attacks). In both trials, a significantly greater proportion of patients treated with Elyxyb achieved pain freedom and most bothersome symptom freedom at 2 hours postdose compared with those who received placebo.

The most common adverse reaction reported with Elyxyb was dysgeusia. Like other NSAIDs, Elyxyb carries a Boxed Warning related to the risk of serious cardiovascular and gastrointestinal adverse events.

Elyxyb is supplied as an oral solution containing 25mg of celecoxib per mL (120mg/4.8mL) in glass bottles and is now available in pharmacies. For patients who are prescribed the recommended dosage of 120mg, the entire amount of Elyxyb may be consumed directly from the bottle. The maximum dosage in a 24-hour period is 120mg.

Reference

Scilex Holding Company announces the commercial launch of Elyxyb (celecoxib oral solution) in the US, strengthening its leadership position in non-opioid pain management. News release. Scilex Holding Company. Accessed February 27, 2023. https://www.globenewswire.com/news-release/2023/02/27/2616161/0/en/Scilex-Holding-Company-announces-the-commercial-launch-of-ELYXYBTM-celecoxib-oral-solution-in-the-U-S-strengthening-its-leadership-position-in-non-opioid-pain-management.html.