Diseases & Diagnoses
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The Food and Drug Administration (FDA) has scheduled an end-of-phase 2 clinical trial meeting for a sublingual formulation of racemic ketamine (Wafermine; iX Biopharma, Singapore) for treatment of moderate-to-severe acute pain. The therapy contains R and S isomers of ketamine in equal proportions In a phase 2b randomized placebo-controlled study (NCT03246971) participants experienced analgesic efficacy from ketamine with safety and tolerability for treatment of acute post-operative pain after abdominoplasty or bunionectomy. In pharmacokinetic studies (NCT01377831),...
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...
The American Stroke Association (ASA) has published updated recommendations for stroke care systems (Stroke. 2019;50:00-00). The recommendations comprehensively review evidence evaluating stroke care systems and update previous ASA recommendations based upon advances in stroke care systems. Among such advances are stroke center certifications, remarkable improvement in endovascular therapy, neurocritical care, telestroke, mobile stroke units, and other innovations. All of this has occurred while the landscape of health care in the US has undergone large changes. The statement addresses...
Umer Najib, MD, FAHS; Jessica Frey, MD; and David B. Watson, MD, FAHS, FAAN
Katharine Nicholson, MD
Deena Kuruvilla, MD