Cenobamate Provides Long-Term Seizure Reduction, Nerivio's Impact in Chronic Migraine, Weekly Episodes Reduced With FT218

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This week Neurology News Network covered the effect of cenobamate on reducing seizures and antiseizure medications, safety of the Nerivio REN device in chronic migraine, and additional data from the phase 3 REST-ON study of FT218 in patients with narcolepsy.

Welcome to this special edition of Neurology News Network. I’m Marco Meglio. Please excuse our appearance this week as a majority of the US workforce, including the NeurologyLive team, moves to working remote as we come together to help reduce the spread of the novel coronavirus.

Two newly published post-hoc analyses from the phase 3 open-label safety study, C021, showed that long-term treatment with cenobamate (Xcopri; SK Life Science) provided safe and effective reduction of seizure frequency, and was associated with concomitant antiseizure medication (ASM) dose reductions. Study C021 was a multicenter study assessing the safety of cenobamate as adjunctive therapy in 1340 adults, aged 18 to 70 years, with uncontrolled focal seizures taking 1-3 ASMs. Cenobamate, an FDA-approved medication for partial-onset seizures, was initiated at 12.5 mg per day and increased at 2-week intervals to 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg per day for at least 6 months.For the total treatment duration, 71.7% (n = 172) of patients experienced at least 50% response rate to treatment. During titration, these rates were 48.1% during weeks 1-4 and 61.7% during weeks 5-8.

Newly published data on Theranica’s remote electrical neuromodulation (REN) device, Nerivio, showed that the acute treatment is safe and provides relief of migraine headaches and associated symptoms in patients with chronic migraine. The prospective, open-label trial, aimed to validate and provide further evidence on the safety and effectiveness of Nerivio in a cohort of 126 patients with CM treated for 4 weeks. Using an electronic diary to record their symptoms, investigators recorded the percentage of subjects who achieved pain relief at 2 hours posttreatment as the primary end point. Pain freedom and improvement of associated symptoms and functional disability were secondary end points. Of the 91 individuals who had evaluable treatment with REN, 54 (59.3%) achieved pain relief and 19 (20.9%) achieved pain disappearance at 2 hours. Additionally, 64.4% of those who achieved pain relief at that time point had sustained pain relief at 24 hours following treatment.

Additional data from the completed phase 3 REST-ON clinical trial of FT218, a once-nightly sodium oxybate formulation for treatment of excessive daytime sleepiness (EDS) and cataplexy in patients with narcolepsy, were presented at the 2021 American College of Chest Physicians (CHEST) virtual meeting. Post-hoc data included analyses of sleep latency response and cataplexy response with once-nightly use of the investigational formulation from Avadel Pharmaceuticals. Additional data was presented from a discrete choice experiment (DCE), which evaluated treatment preferences among patients. Significant improvement in the number of weekly cataplexy episodes was also associated with FT218 treatment, compared to placebo. Patients treated with the 6-g FT218 dose had a 25% reduction in weekly episodes, those treated with the 7.5-g had a 50% reduction, and those treated with the 9-g dose had a 75% reduction. Approximately 10% of patients receiving the 7.5-g and 9-g doses—the 2 highest doses—had elimination of cataplexy, half had a 50% reduction, and one-third had a 75% reduction in weekly episodes.

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