Cenobamate Gets Schedule V Designation, ICER Publishes Migraine Treatment Review, FDA Approves RNS System Labeling Update

This week Neurology News Network covered the Schedule V designation for cenobamate, the FInal Evidence Report on 3 approved acute migraine treatments, and the labeling update for NeuroPace's RNS system.

Marco: Welcome to Neurology News Network. I’m Marco Meglio. Let’s get into the news from this week.

SK Life Science has announced that its newly approved treatment for partial-onset seizures in adults, cenobamate has been designated as a Schedule V medicine by the DEA, the lowest designation for abuse from the agency. The sodium channel antagonist was originally approved by the FDA for this indication in late November 2019, with the approval supported by data from pivotal trials that assessed the efficacy and safety of cenobamate in more than 1900 total patients. It was shown to significantly reduce partial-onset seizure frequency, with up to 20% of patients achieving seizure-free status during the maintenance phases. Cenobamate is expected to launch in the second quarter of 2020.

The Institute for Clinical and Economic Review has released its Final Evidence Report and accompanying Report-at-a-Glance on the clinical effectiveness and economic value of a trio of recently approved acute migraine treatments. They include lasmiditan, rimegepant, and ubrogepant, deciding that the available evidence suggests with moderate certainty that all 3 offer a small or substantial net health benefit, and with a high certainty of at least a small net health benefit. Clinical trial data suggest that the therapies all decrease symptoms of migraine attacks and improve function compared with placebo for those who are unable to take triptans, and ICER noted that for those who can, its indirect comparisons imply that triptans are similar or more effective than these newly approved agents. ICER noted that without evidence showing superiority to other, less expensive options, clear and effective prior authorization criteria based on clinical evidence, specialty society guidelines, and input from clinical experts and patient groups would be reasonable to develop to ensure practical use of these new therapies.

The FDA has approved a labeling update for NeuroPace’s responsive neurostimulation system, allowing treatment for patients with non-brain MRI requirements and individuals with focal onset seizures that require monitoring for brain anomalies, such as tuberous sclerosis complex, brain tumors, or multiple sclerosis. The FDA’s decision was based off a real-world study that showed an 82% median seizure frequency reduction at 3 years, with 1 in every 3 patients achieving 90% or greater seizure reduction. The latest approval of MRI labeling for the RNS system may add an additional treatment option to the antiseizure armamentarium for those with refractory epilepsy who were previously restricted by the need for necessary imaging.

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