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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),...
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...
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...
Cynthia E. Armand, MD; Alina Masters-Israilov, MD; and Richard B. Lipton, MD
Katharine Nicholson, MD
Emmanuelle A. D. Schindler, MD, PhD; and Christopher Gottschalk, MD