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FDA Approves Vanda’s Nereus to Prevent Motion-Induced Vomiting

The decision delivers the first pharmacologic therapy for motion sickness in more than 40 years.

Overview

  • In two Phase III real-world boat studies with 681 participants, Nereus cut vomiting rates to about 10%–20% versus roughly 38%–44% on placebo, with strong statistical significance.
  • Nereus is an oral neurokinin‑1 receptor antagonist that targets substance P, a mediator of nausea and vomiting.
  • Common adverse reactions reported in trials included somnolence (6%–12%) and fatigue (6%–8%).
  • The FDA lifted a 2018 partial clinical hold on December 4 after reclassifying motion sickness as an acute condition, clearing the path to approval.
  • Vanda expects a U.S. launch in the coming months, and its shares rose about 20% in after-hours trading following the announcement.