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FDA Approves Vanda’s Nereus for Motion-Induced Vomiting, First New Option in Over 40 Years

Late-stage trials in 681 patients showed significant reductions in vomiting, prompting the FDA decision.

Overview

  • Vanda said it expects to launch Nereus in the coming months.
  • The drug, also known as tradipitant, works by blocking a brain receptor linked to nausea and vomiting.
  • Approval was supported by two placebo-controlled studies in which the treatment outperformed placebo on vomiting prevention.
  • Existing options for motion-related symptoms include the scopolamine patch Transderm Scop and over-the-counter products Bonine and Dramamine.
  • The FDA lifted a prior partial clinical hold on tradipitant on December 4 after classifying motion sickness as an acute condition.