Zavegepant Effective Regardless of Aura Status, FDA Approves Extended-Release Sodium Oxybate, Mediterranean Diet Adherence Improves MS Cognition

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Neurology News Network for the week ending May 6, 2023. [WATCH TIME: 4 minutes]

WATCH TIME: 4 minutes

Welcome to this special edition of Neurology News Network. I’m Marco Meglio.

Post-hoc findings from 2 randomized, double-blind trials assessing zavegepant (Zavzoret; Pfizer), an FDA-approved calcitonin gene-related peptide (CGRP) antagonist, continued to support the therapy’s efficacy as an acute treatment for migraine, regardless of the presence or absence of aura. Pooling data from phase 2/3 and phase 3 studies, 2061 patients who were randomly assigned to either zavegepant or placebo were included. Above all, zavegepant outperformed placebo on the coprimary end point of 2h pain freedom for patients with and without predose aura. As for achieving freedom 2h from most bothersome symptoms, the CGRP medication continued to be beneficial regardless of aura status. In addition to showing significant results on the co-primary end points, zavegepant demonstrated benefit on pain relief as early as 15 minutes postdose in participants with predose aura and in participants without predose aura.

After recently submitting an amendment to the FDA’s request for final approval, Avadel Pharmaceuticals announced the agency has officially approved its oral, extended-release formulation of sodium oxybate for the treatment of cataplexy or excessive daytime sleepiness in adults with narcolepsy. Marketed as Lumryz, it becomes the first and only FDA-approved once-nightly oxybate for patients with the condition. Lumryz comes with a boxed warning as a central nervous system depressant, and for its potential abuse and misuse. It is currently only available through a restricted program under a Risk Evaluation and Mitigation Strategy called the Lumryz REMS. With the approval, the drug was granted 7 years of orphan drug exclusivity.

Data from a cohort of patients with multiple sclerosis (MS) revealed significant associations between higher adherence to Mediterranean diet and cognition, suggesting the possibility of a neuroprotective mechanism. Led by Ilana K. Sand, MD, associate professor of neurology, Mount Sinai, the trial featured 563 individuals with MS who completed the Mediterranean Diet Adherence Screener (MEDAS) and an analogue of the popular BICAMS test. Patients scored 0-14 on MEDAS while also completing additional measures such as Symbol Digit Modalities Test, Hopkins Verbal Learning Test-Revised, and CANTAB Paired Associate Learning. Slightly less than 20% (19.2%) of patients demonstrated cognitive impairment, as higher MEDAS scores independently predicted 20% lower risk for cognitive impairment.

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