FDA Clears Modius Sleep Device, NDA Accepted for SPN-830, Zilucoplan Improves Myasthenic Fatigue


Neurology News Network for the week ending November 11, 2023. [WATCH TIME: 3 minutes]

WATCH TIME: 3 minutes

Welcome to this special edition of Neurology News Network. I’m Marco Meglio.

According to an announcement from Neurovalens, the FDA has granted 510(k) clearance for its Modius Sleep device as a new treatment for patients with chronic insomnia. The company is now planning to enter discussions with insurance providers to achieve reimbursement status so patients can access the treatment through their medical insurance. Modius Sleep is a transdermal neurostimulation device with a battery-powered headset designed to transcutaneously deliver low-level electrical current to a patient’s head to treat insomnia. The device delivers neurostimulation through 2 self-adhesive electrode pads that are placed on the subject’s skin overlying each mastoid process behind the ear. In its announcement, Neurovalens claimed that it has approvals pending for the sleep device in other conditions of anxiety and obesity.

According to an announcement, the FDA has accepted Supernus Pharmaceuticals’ resubmitted new drug application (NDA) for SPN-830, an apomorphine infusion device designed for the treatment of OFF episodes in patients with Parkinson disease (PD). The FDA is expected to reach a decision on whether to approve the therapy by April 5, 2024, the scheduled PDUFA date. SPN-830 is an experimental under-the-skin continuous infusion therapy for reducing motor fluctuations in patients with PD between doses of standard levodopa-based therapy. The phase 3 TOLEDO study, a double-blind, randomized, multicenter trial, served as the supportive data for the NDA. In the study, treatment with SPN-830 resulted in –1.89 hours per day better OFF time for treated patients vs those on placebo.

In a new post hoc analysis of the phase 3 RAISE study and its open-label extension, RAISE-XT, treatment with zilucoplan significantly and clinically meaningfully improved myasthenic fatigue compared with placebo and had further improvements that were sustained for up to 60 weeks. These findings suggest zilucoplan has potential in reducing fatigue symptoms in patients living with generalized myasthenia gravis. At the end of RAISE at week 12, least squares mean (LS) change from baseline in the Quality of Life in Neurological Disorders (Neuro QoL) Short Form fatigue T-score was −6.26 for zilucoplan-treated patients with gMG (n = 86) compared with –2.65 for the placebo group.

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