Diseases & Diagnoses
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The Food and Drug Administration (FDA) has approved amifampridine (Ruzurgi; Jacobus Pharmaceutical Company, Princeton, NJ) for treating Lambert-Eaton myasthenic syndrome (LEMS) in patients age 6 to 17 years. This is the first FDA approval of a therapy specifically for pediatric patients with LEMS, a rare autoimmune neuromuscular junction disorder. Use of amifampridine in pediatric patients is supported by clinical studies in adults with LEMS, pharmacokinetic data in adult patients, pharmacokinetic modeling and simulation to identify the dosing regimen in pediatric...
Impel Neuropharma (Seattle, WA) is developing new therapeutic formulations for delivery of therapeutic compounds to the upper nasal cavity with their precision olfactory delivery (POD) device. The POD uses a propellant to deliver drugs to the upper nasal cavity, a new route of administration, which can provide higher bioavailability and rapid uptake vs traditional nasal sprays The POD device is easy to use, requiring only that the nasal tip of the device is inserted into the nostril and squeezed once to activate dose delivery. Coordination of breathing with activation is not required, and...
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...
Cynthia E. Armand, MD; Alina Masters-Israilov, MD; and Richard B. Lipton, MD
Gordon H. Baltuch, MD, PhD
Regina Krel, MD; and Paul G. Mathew, MD, DNBPAS, FAAN, FAHS