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US FDA Approves Vanda Pharmaceuticals' Motion ...

NEREUS showed vomiting risk reductions over 50% to 70% in pivotal trials, marking the first new motion sickness drug in 40 years, Vanda said.

  • On Dec. 30, 2025, Vanda Pharmaceuticals Inc. announced FDA approval of NEREUS in Washington, expecting its launch in the coming months.
  • Motion sickness arises from sensory conflict that triggers substance P release and NK-1 receptor activation, affecting about 25% to 30% of U.S. adults .
  • Across the pivotal program, two Phase 3 boat provocation studies, Motion Syros and Motion Serifos, showed vomiting rates of 18.3%–19.5% and 10.4%–18.3%, with adverse reactions including somnolence and fatigue.
  • Shares of Vanda Pharmaceuticals jumped after the approval, with the company stating Mihael H. Polymeropoulos called it "transformative"; market reaction remains to be seen.
  • Vanda said it will advance tradipitant development programs for gastroparesis and GLP-1 receptor agonist–induced nausea and cautioned investors with forward-looking statements and risk disclosures.
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The Berkshire EagleThe Berkshire Eagle
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Vanda Pharmaceuticals Announces FDA Approval of NEREUS™ (tradipitant) for the Prevention of Vomiting Induced by Motion: A Historic Scientific Milestone in the Prevention of Motion Sickness

WASHINGTON, Dec. 30, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has approved NEREUS™ (tradipitant), an oral neurokinin-1 (NK-1) receptor antagonist, for the prevention of vomiting induced by motion.…

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Reuters broke the news in United Kingdom on Tuesday, December 30, 2025.
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