Perampanel Improves Comorbid Epilepsy and Migraine, Masupidine to Treat Alzheimer Agitation, Fenfluramine Potential FDA-Approval in LGS


Neurology News Network for the week ending December 4, 2021. [WATCH TIME: 4 minutes]

WATCH TIME: 4 minutes

This week Neurology News Network covered a study evaluating the effects of perampanel in comorbid epilepsy and migraine, masupirdine's impact on Alzheimer disease agitation, and the FDA's decision to accept the sNDA of fenfluramine to treat Lennox-Gastaut 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.

Perampanel (Fycompa; Eisai), an FDA-approved antiseizure (ASM) medication, significantly reduced epileptic seizures, migraine attacks, and the use of monthly rescue migraine medications over a 12-month stretch in a cohort of patients with comorbid epilepsy and migraine. For years, the mechanisms underlying the association of epilepsy and migraine have not been fully understood; however, some common pathophysiological processes in migraine and epilepsy have been recognized.2,3 In this observational study, investigators aimed to confirm the effectiveness of perampanel in 31 enrolled patients with comorbid epilepsy and migraine. Treatment with perampanel showed significant impact on reducing migraine, with 10 patients not experiencing a single migraine attack throughout the 12-month period. Additionally, 7 participants reported at least 75% reduction in migraine attacks, 5 had reductions of at least 50%, 4 had a reduction of at least 25%, and 1 patient remained unchanged.

Findings from the phase 2a multicenter, randomized, double-blind, proof-of-concept trial were presented at the 14th Clinical Trials on Alzheimer’s Disease Conference (CTAD). The study spanned a total of 26 weeks, with patients receiving a 50-mg dose of masupirdine, a 100-mg dose of masupirdine, or placebo. Patients who had a baseline neuropsychiatric inventory scale (NPI-A/A) score of 1 point or greater were randomized to receive placebo (n = 57), masupirdine 50 mg (n = 54), or masupirdine 100 mg (n = 48). A significant mean change from baseline was identified in both the 50 mg (P <.001) and 100 mg (P = .007) groups when compared with placebo at week 26. Similarly, in the group of patients with a baseline NPI-A/A score of 3 points or higher, investigators observed a significant mean change from baseline in the masupirdine 50-mg group (n = 30) at both week 13 (P = .012) and week 26 (P = .031) when compared with placebo. A significant change was also seen in the masupirdine 100-mg group at week 26, when compared with placebo.

According to a new announcement, the FDA has accepted for filing and granted priority review designation to Zogenix’s fenfluramine (Fintepla) to treat seizures associated with Lennox-Gastaut syndrome (LGS). The FDA will look to complete the review within the 6-month window, with a prescription user drug fee act (PDUFA) date of March 25, 2022. The application, submitted in September 2021, was backed by data from the phase 3 Study 1601, which showed that treatment with fenfluramine at a dose of 0.7 mg/kg/day was superior to placebo in reducing the monthly drop seizure frequency. Additional long-term safety and effectiveness data in ongoing open-label extension trials were also included in the submission. If approved, this would be the second indication for fenfluramine, after originally being greenlight by the FDA in June 2020 to treat seizures associated with Dravet syndrome in patients 2 years of age and older.

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