Stroke Care Recommendations, FT218 Treatment of Narcolepsy, Portable Neuromodulation Stimulator Device Gains Breakthrough Designation

May 16, 2020

Neurology News Network for the week ending May 16, 2020.

This week Neurology News Network covered new recommendations for stroke care amid COVID-19, the results of a phase 3 trial of FT218 in patients with narcolepsy, and the breakthrough designation of Helius Medical Technologies' Portable Neuromodulation Stimulator device.

Marco Meglio: 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.

This month, a group of authors published recommendations in Neurology to point to the possible issues and their solutions regarding stroke care amid the COVID-19 pandemic. They offered advice and specifically addressed the potential impact of the pandemic on the quality of care, ethical considerations, safety and logistic issues, and research in stroke. The paper ultimately concluded that stroke providers need to balance the overall needs of the community while remaining advocates for those with stroke and the safety of providers, including making adjustments in the delivery care that should be adapted to each unique environment. Additionally, they noted it is important to keep in mind that as care continues during the pandemic, stroke providers will need to rely on prediction modeling and surge planning to continue to adapt to best serve all patients with stroke. Andrew N. Russman, DO, head, Stroke Program, and medical director, Comprehensive Stroke Center, Cleveland Clinic, and coauthors wrote that they anticipate that ongoing and emergent research will continue to offer additional insights that will provide evidence which could prompt the modification or removal of some of their recommendations.

Avadel Pharmaceuticals announced its investigational, once-nightly formulation of sodium oxybate, FT218, met all 3 of its co-primary end points in the phase 3 REST-ON trial for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy. All 3 doses (9 g, 7.5 g, and 6 g) of FT218 demonstrated highly significant, clinically meaningful improvements on the Maintenance of Wakefulness Test (MWT), Clinical Global Impression-Improvement (CGI-I) scores, and mean weekly cataplexy attacks. Greg Divis, chief executive officer, Avadel, said in a statement, “We look forward to sharing the results from the REST-ON study with the FDA and progressing toward a potential approval that would allow us to bring this important treatment to the patients who need it most. If approved, FT218 would be the first once-nightly therapy to address both excessive daytime sleepiness and cataplexy in patients with narcolepsy.”

Helius Medical Technologies announced today that its Portable Neuromodulation Stimulator device, a short-term treatment for gait deficit due to mild and moderate symptoms of multiple sclerosis (MS) used in conjunction with supervised physical therapy, has received a breakthrough designation by the FDA. The PoNS is currently authorized for sale in Canada as a class II, non-implantable medical device, where it is also indicated as a short-term, 14-week treatment for chronic balance deficit due to mild-to-moderate traumatic brain injury. It is still an investigational medical device in the United States, Europe, and Australia. In January, Helius was awarded the Pioneer Technology Development Award for the PoNS device, presented by the Brain Mapping Foundation and Society for Brain Mapping and Therapeutics, given to trailblazing technology companies and their CEOs and presidents who have facilitated the development of pioneering technologies through interdisciplinary approaches that have impacted diagnostics, treatment, and healthcare delivery in unprecedented ways.

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