FDA Approves Genio OSA Therapy, Improved Motor Function With FUS, Soticlestat Evaluated in Dravet Sydrome

February 13, 2021
NeurologyLive Staff

Neurology News Network for the week ending February 13, 2021.

This week Neurology News Network covered the FDA approval of Nyxoah's Genio neurostimulation-based obstructive sleep apnea therapy, a study on the benefits of focused ultrasound in Parkinson disease, and the results of the ELEKTRA study evaluating soticlestat in children with Dravet syndrome.

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.

The FDA has approved a magnetic resonance imaging (MRI) conditional labeling for Nyxoah’s Genio neurostimulation-based obstructive sleep apnea (OSA) therapy, currently being evaluated in the DREAM pivotal investigational device exemption (IDE) study.The revised labeling ensures patients who have already implanted the Genio system and those set to receive the therapy can now undergo full-body 1.5T and 3T MRI diagnostic scans within approved parameters, along with accessing the benefits that the unique bilateral stimulation therapy brings. Nyxoah received IDE approval from the FDA in June 2020 for the DREAM (Dual-sided Hypoglossal neRvE stimulAtion for the treatMent of Obstructive Sleep Apnea) study, which aims to confirm the safety and effectiveness of the Genio system in 134 moderate to severe patients with OSA who failed first line continuous positive airway pressure (CPAP) therapy.

Recently published study data in The New England Journal of Medicine suggest that treatment with focused ultrasound (FUS) subthalamotomy in a single brain hemisphere is associated with improved motor features in individuals with Parkinson disease (PD) who had asymmetric signs of disease. Movement Disorder Society–Unified Parkinson’s Disease Rating Scale (MDS-UPDRS III) motor scores improved for the treated group (n = 27) by 9.8 points from a 19.9 baseline score. In comparison, the control sham-treatment group (n = 13) experienced an improvement of 1.7 points from a baseline score of 18.7, with the between-group difference totaling 8.1 points. Additionally, Patients’ Global Impression of Change (PGI-C) scores at 4 months were reported by 85% of patients (n = 23) in the active-treatment group, but only 15% (n = 2) of the control group. For the 25 patients with data, the change from baseline to 12 months in the MDS-UPDRS III score for the more affected side was 11.6 points.

Data from the phase 2, multicenter, randomized, placebo-controlled, double-blind, parallel-group ELEKTRA study suggest that soticlestat treatment resulted in statistically significant reductions in seizure frequency from baseline in children with Dravet syndrome. These data were presented by Cecil Hahn, child neurologist, The Hospital for Sick Children, and associate professor of pediatrics, University of Toronto, and colleagues at the American Epilepsy Society (AES) Virtual Meeting, December 4–8, 2020. Hahn and colleagues wrote that “in this phase 2 study, soticlestat treatment resulted in a statistically significant reduction in median seizure frequency compared to baseline in children with DS, and in a directional reduction in seizure frequency in patients with [Lennox-Gastuat syndrome; LGS] and was generally well-tolerated.”

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