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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,...
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)...
Treatment with ubrogepant (Allergan, Madison, NJ) resulted in similar magnitudes of pain relief for participants who had triptan-nonreponsive migraine (n ~1,000), triptan-responsive migraine, or who were naïve to triptan treatment. Individuals in the triptan-nonresponsive group included primarily people for whom triptans had been ineffective (~80%), with some having intolerability to triptans (~17%) and a few having contraindications (~3%). Treatment-emergent adverse events were not serious and were also similar amongst the 3 groups and those who took placebo. In the ACHIEVE II...
Gordon H. Baltuch, MD, PhD
Charisse Litchman, MD, FAHS; and Sirisha Sanamandra, MBBS
Ronald Devere, MD, FAAN