Vanda Pharmaceuticals has announced that the US Food and Drug Administration has approved NEREUS (tradipitant), an oral neurokinin-1 (NK-1) receptor antagonist, for the prevention of vomiting caused by motion sickness.

This marks the first new pharmacologic treatment for motion sickness in more than four decades, a milestone for a condition that affects millions of Americans and has long posed challenges for military operations.

"This approval underscores the strong scientific evidence in the antiemetic effects of NEREUS in motion sickness," said Mihael H. Polymeropoulos, President, CEO and Chairman of the Board of Vanda Pharmaceuticals.

"For the first time in over 40 years, patients have access to a novel therapy grounded in modern neuropharmacology, offering effective prevention without the limitations of existing options. We are proud of this historic milestone and grateful to the Vanda researchers, patients, investigators, and regulators who contributed to this achievement."

The approval is supported by data from three pivotal clinical trials, including two Phase 3 studies conducted on boats—Motion Syros and Motion Serifos—and one supporting study with participants who had documented histories of motion sickness.

In Motion Syros (n=365), vomiting occurred in 18.3–19.5% of NEREUS patients versus 44.3% on placebo (p<0.0001). Motion Serifos (n=316) showed vomiting rates of 10.4–18.3% with NEREUS™ compared with 37.7% on placebo (p≤0.0014), representing risk reductions of 50–70%. Across all studies, NEREUS consistently reduced vomiting and showed a favorable safety profile for acute use.

Motion sickness has historically been a critical military concern, dating back to World War II. Globally, up to one-third of individuals are highly susceptible, with 5–15% experiencing severe symptoms that can disrupt daily life and limit travel.

The underlying cause of motion sickness is a sensory conflict that triggers the release of substance P and activates NK-1 receptors in the brain, leading to nausea and vomiting. NEREUS works by selectively blocking NK-1 receptors, directly addressing this pathway.

The approval also positions Vanda to explore tradipitant in other nausea-related conditions, including gastroparesis and nausea caused by GLP-1 receptor agonists, commonly used in obesity and diabetes treatment. Vanda expects to launch NEREUS in the coming months and is focused on expanding its use for other substance P-mediated disorders.