JZP-258 sNDA Accepted, FDA Clears gammaCore nVNS, Prevalence of Seizure Cycles

This week Neurology News Network covered the supplemental new drug application decision for JZP-258, the FDA clearance of the gammaCore noninvasive vagus nerve stimulation device, and the prevalence of seizure cycles.

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.

Jazz Pharmaceuticals has announced that its supplemental new drug application (sNDA) for its calcium, magnesium, potassium, and sodium oxybates combination agent known as JZP-258 (marketed as Xywav) in the treatment of idiopathic hypersomnia was accepted by the FDA for review.The therapy won a fast track designation from the FDA in September 2020 for this indication, and in December was granted a rolling submission, allowing for the submission of portions of the application as completed. Jazz stated that it plans to bring JZP-258 to patients in the fourth quarter of 2021, pending its potential approval. Currently, there are no approved agents for the treatment of idiopathic hypersomnia, with the majority of physicians turning to off-label use of wake-promoting therapies with effectiveness in those with narcolepsy to help address the sleepiness issues.

The FDA has cleared the expansion of the gammaCore noninvasive vagus nerve stimulation (nVNS) device’s label to include the preventive treatment of migraine in adolescent patients aged between 12 and 17 years, according to its manufacturer electroCore. Eric Liebler, senior vice president of neurology, electroCore, noted in a statement that this marks gammaCore as the only option acute and preventive for both adult and adolescent patients with migraine, which he noted is “represents a unique treatment” for those seeking to avoid the use of prescription pharmaceutical agents.Previously reported randomized controlled trial data offered the basis for this label expansion, as well as a small study in adolescents (n = 9) with migraine with aura, in which 46.8% (n = 22) of 47 treated attacks were successfully resolved without the use of any acute rescue medication. There were no device-related adverse events (AEs) reported in the preliminary study.

Findings from a retrospective cohort study indicate that plural seizure cycles are highly prevalent among patients with refractory focal epilepsy and help explain the natural variability in seizure timing.The investigators found that the prevalence of circannual (approximately 1 year) seizure cycles was 12% (24 of 194), the prevalence of multidien (approximately weekly to approximately monthly) seizure cycles was 60% (112 of 186), and the prevalence of circadian (approximately 24 hours) seizure cycles was 89% (76 of 85). These researchers used data from continuous intracranial electroencephalography (cEEG) and seizure diaries collected between January 19, 2004 and May 18, 2018, with durations up to 10 years. Measures involved self-reported daily seizure counts, cEEG-based hourly counts of electrographic seizures, and detections of interictal epileptiform activity (IEA), which fluctuates in daily (circadian) and multiday (multidien) cycles.

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