RimabotulinumtoxinB for Sialorrhea, Zogenix Resubmits Fenfluramine NDA, Long-Term Lemborexant Insomnia Data

This week, Neurology News Network covered the latest data demonstrating the long-term efficacy and rapid treatment effect of rimabotulinumtoxinB for sialorrhea, Zogenix's resubmitted NDA for fenfluramine, and new 12-month data on lemborexant for the treatment of insomnia.

Alicia: Welcome to Neurology News Network. I’m Alicia Bigica. Let’s get into the news from this week.

Data presented at the 2019 International Congress of Parkinson Disease and Movement Disorders in Nice, France demonstrate the long-lasting and rapid effect of rimabotulinumtoxinB for the treatment of sialorrhea. The injection, which was approved by the FDA last month, demonstrated long-term safety and efficacy over 1 year in an open-label study, where patients experienced a significant reduction in mean unstimulated salivary flow rate from baseline to week 4, with efficacy maintained through week 13. Additional results from a double-blind, placebo-controlled trial showed that patients who received either 2500 or 3500 units reported improvements as early as week 1.

After receiving a refusal to file letter from the FDA in April, Zogenix has resubmitted its new drug application for fenfluramine for the treatment of seizures associated with Dravet syndrome.

The original application was denied based on missing nonclinical studies and an incorrect clinical dataset. At the time of resubmission, Dr Stephen J. Farr, president and CEO of Zogenix, said that “We believe that Fintepla, if approved, could become an important new treatment option for patients and families living with Dravet syndrome. We appreciate the FDA’s guidance through the resubmission process and look forward to continuing to work closely with the Agency during their review of our application.”

New 12-month data from the phase 3 SUNRISE-2 study of lemborexant for the treatment of insomnia suggests that the drug is both effective and well-tolerated over a 1-year period. Notably, sleep latency was reduced by nearly 20 minutes in patients treated with either the 5mg or 10mg dose, with efficacy maintained through months 6 and 12. The new drug application for lemborexant was accepted by the FDA in March, with a PDUFA date set for the end of December.

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