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Post hoc analysis shows that participants who took 100 mg or 200 mg of lasmitidan had statistically significant increases in the rate of pain relief and freedom from the most bothersome symptom (MBS) (ie, nausea, photophobia, or phonophobia) (P < .001 starting as early as 30 minutes after administration. Participants who rated themselves as nonresponders, poor responders, or good responder to triptans did not have significant differences in their responses to 200 mg lasmiditan in any measure (freedom from pain at 2 hours, freedom from MBS, or pain relief). Participants who...
The Food and Drug Administration (FDA) has approved onasemnogene abeparvovac-xioi (Zolgensma; Avexis, Bannockburn, IL) for the treatment of all types of spinal muscular atrophy (SMA) in children under age 2 years. Approved indications for onasemnogene, an SMN gene-replacement therapy, include all types of SMA. Treatment of presymptomatic children diagnosed through genetic screening is also approved. Not all states include testing for SMA in newborn screening panels, however. Onasemnogene is given intravenously in a single 1-time infusion. In 2 clinical trials (STRIVE [NCT03306277] and...
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),...
Niushen Zhang, MD
Deena Kuruvilla, MD
Saif A. Bushnaq, MD; and Sunil A. Sheth, MD