In December, the U.S. Food and Drug Administration (FDA) approved Vanda Pharmaceuticals Inc.‘s (NASDAQ:VNDA) Nereus (tradipitant) to prevent vomiting induced by motion.
The approval marks the first new pharmacologic treatment for motion sickness in over four decades.
Data from three trials support the efficacy of Nereus—two Phase 3 real-world provocation studies conducted on boats (Motion Syros and Motion Serifos) and one additional supporting study, with participants who had documented histories of motion sickness.
In Motion Syros (n=365), vomiting incidence was 18.3–19.5% with Nereus versus 44.3% with placebo.
In Motion Serifos (n=316), vomiting rates were 10.4–18.3% with Nereus versus 37.7% with placebo, representing risk reductions of over 50–70%.
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Across the pivotal program, Nereus consistently demonstrated significant reductions in vomiting and a favorable safety profile consistent with acute use.
In November 2025, data from a controlled trial demonstrated tradipitant's potential to mitigate GLP-1-induced nausea and vomiting. Over 29% of tradipitant-treated participants (17/58) experienced vomiting compared to 58.6% on placebo (34/58), representing a 50% relative reduction.
HC Wainwright: Selvaraju wrote, “…the approval may signal only the beginning of a sea change in regulatory perception of this agent, which also has applicability in two much more lucrative markets.”
B Riley Securities: El-Saadi on Tuesday wrote, “…the approval reinforces our view that VNDA represents an ongoing turnaround story with shares still trading at an excessive discount heading into two more potential approvals within the next 12 months.
Cantor Fitzgerald: Brayer expects tradipitant to be priced at a premium vs. existing OTC products on the market. Pricing is the key hurdle for this launch, especially given the availability of much cheaper OTC alternatives. To improve affordability, the company plans to offer an eight-tablet bottle, which Cantor estimates will be priced above $500 per bottle.
Jefferies: The firm envisions a steady launch curve as awareness builds over time, with some contribution from patients who have been waiting for an alternative to existing therapies.
A modest penetration among dissatisfied users or patients who currently avoid travel could drive meaningful sales in theory. However, launch adoption will be sensitive to out‑of‑pocket costs, since dramamine is inexpensive.
Price Action: VNDA stock is up 1.25% at $7.97 at the last check on Tuesday.
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