Vanda Pharmaceuticals Inc. has announced that the U.S. Food and Drug Administration has approved NEREUS™ (tradipitant), an oral neurokinin-1 (NK-1) receptor antagonist, for the prevention of vomiting induced by motion. This marks the first new pharmacologic treatment for motion sickness in more than four decades, representing a significant advancement in managing a condition that affects a substantial portion of the population and has historically impacted military operational readiness.
The approval is based on data from three pivotal clinical trials, including two Phase 3 real-world studies conducted on boats—Motion Syros (n=365) and Motion Serifos (n=316)—and one additional supporting study. In Motion Syros, vomiting occurred in 18.3–19.5% of participants receiving NEREUS™ compared with 44.3% in the placebo group.
In Motion Serifos, vomiting rates ranged from 10.4–18.3% with NEREUS™ versus 37.7% with placebo, representing risk reductions of over 50–70%. Across the clinical program, NEREUS™ consistently demonstrated significant reductions in vomiting and a favorable safety profile consistent with acute use.
Motion sickness remains a common problem, affecting approximately 25–30% of adults in the United States, or roughly 65–78 million people, during travel by car, plane, or boat. Globally, up to one-third of individuals are highly susceptible, with an estimated 5–15% experiencing severe, recurrent symptoms that can significantly impact quality of life. Severe cases often result in avoidance of motion-inducing activities, altered travel plans, and reliance on pharmacologic treatments, including over-the-counter options and, in some cases, prescription therapies.
Historically, motion sickness has also been recognized as a factor affecting military operations, notably during World War II’s D-Day invasion, when seasickness among troops impaired operational effectiveness. Motion sickness arises from sensory conflict between visual, vestibular, and proprioceptive inputs, triggering the release of substance P and activation of NK-1 receptors in the central nervous system, leading to nausea and vomiting. NEREUS™ targets this pathway through potent and selective NK-1 receptor antagonism, providing effective prevention of vomiting induced by motion.
The FDA approval of NEREUS™ not only validates its pharmacologic profile but also opens the path for further exploration of NK-1 antagonists in related conditions. Vanda is advancing tradipitant in clinical development for gastroparesis, a chronic disorder characterized by delayed gastric emptying and persistent nausea and vomiting, as well as for prevention of nausea and vomiting induced by GLP-1 receptor agonists, which are commonly used in obesity and diabetes management.
Vanda Pharmaceuticals plans to launch NEREUS™ for the prevention of vomiting induced by motion in the coming months and continues to explore its therapeutic potential across substance P-mediated pathways.
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