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The nasally administered benzodiazepine spray midazolam (Nayzilam; UCB, Smyrna, GA) has been approved by the Food and Drug Administration (FDA) for acute treatment of frequent seizure activity in people age 12 and up with epilepsy. The nasal spray is a single-use treatment that can be administered when a seizure cluster occurs. Midazolam is the first new medication approved for treating seizure clusters in more than 20 years in the US. In a randomized double-blind clinical trial (NCT01390220), a statistically significant higher proportion of seizure episodes treated with midazolam (n = 134)...
Diroximel fumarate (DRF)(ALKS8700, BIIB098; Alkermes, Waltham, MA and Biogen, Cambridge, MA) is an oral fumarate in development for treatment of multiple sclerosis (MS). Like dimethyl fumarate (DMF) (Tecfidera; Biogen, Cambridge, MA), DRF is a prodrug that is converted to monomethyl fumarate. The unique chemical structure of DRF, however, creates potential for similar efficacy with better gastrointestinal tolerability; this is supported by interim data from week 48 of a 96-week open-label safety study (NCT02634307) presented at the American Academy of Neurology May 4-10 in Philadelphia,...
Treatment with inebilizumab (VielaBio, Gaithersburg, MD) reduced relapses of neuromyelitis optica spectrum disorder (NMOSD) by 77% after 28 weeks of treatment. Response to treatment with inebilizumab for NMOSD was safe and effective such that the trial was terminated early as it was deemed unethical not to treat participants in the placebo arm of a phase 3 trial (NCT02200770). After this judgement was made, all participants in the placebo arm began receiving inebilizumab on an open-label extension basis. Treatment with inebilizumab also reduced worsening from baseline score on...
Ronald Devere, MD, FAAN
Cynthia E. Armand, MD; Alina Masters-Israilov, MD; and Richard B. Lipton, MD
Lauren Doyle Strauss, DO, FAHS; and Scott Otallah, MD