FDA Approves Tradipitant as First New Motion Sickness Drug in 40+ Years
The FDA has approved tradipitant (Nereus), an oral NK-1 receptor antagonist, for preventing motion-induced vomiting in adults. This marks the first new treatment for motion sickness in over four decades and represents a significant advance in understanding and managing the condition.
This approval marks the first new pharmacologic treatment in motion sickness in over four decades, representing a significant advancement in the understanding and management of this debilitating physiologic response that affects a substantial portion of the population and has long been recognized as a factor affecting military operational readiness.
"This approval underscores the strong scientific evidence in the antiemetic effects of NEREUS™ in motion sickness," said Mihael H. Polymeropoulos, M.D., 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 efficacy of NEREUS™ is supported by robust data from three pivotal clinical trials—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 (p<0.0001).1 In Motion Serifos (n=316), vomiting rates were 10.4–18.3% with NEREUS™ versus 37.7% with placebo (p≤0.0014), representing risk reductions of over 50–70%.2 Across the pivotal program, NEREUS™ consistently demonstrated significant reductions in vomiting and a favorable safety profile consistent with acute use.
Motion sickness has been recognized as a critical factor in military operations since World War II, most notably during the D-Day invasion of Normandy in 1944, where severe seasickness impaired the effectiveness of troops, including paratroopers of the 101st Airborne Division deployed in rough Channel crossings and airborne drops. The condition was elevated to a strategic imperative, prompting early research into antiemetic therapies to ensure operational readiness during large-scale troop deployments by sea, air, and land.
Today, motion sickness remains prevalent in civilian life, with approximately 25–30% of adults3—roughly 65–78 million people in the U.S.—experiencing symptoms during common travel modes such as cars, planes, or boats. Globally, up to one-third of individuals are highly susceptible.4 While most cases are mild, an estimated 5–15% of the population experiences severe, recurrent symptoms that can significantly impact quality of life. This severe segment comprises two key groups: those whose illness is inadequately controlled by existing therapeutic options, leaving them with persistent debilitating symptoms despite treatment, and those whose illness is so severe that it leads to avoidance of engaging in motion-provoking activities altogether, resulting in altered travel plans, missed opportunities, or complete abstention from certain modes of transportation or experiences. Tens of millions seek pharmacologic treatment annually, primarily through over-the-counter options, though many patients opt for prescription therapies when escalating care. Motion sickness arises from a 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™'s mechanism of action—potent and selective antagonism of NK-1 receptors—directly addresses this pathway.
The approval of NEREUS™ for the prevention of vomiting induced by motion validates its pharmacological profile and paves the way for further exploration of NK-1 antagonism in related vomit-inducing conditions. Vanda is advancing tradipitant in clinical development for gastroparesis, a chronic disorder characterized by delayed gastric emptying and persistent nausea/vomiting, as well as for the prevention of nausea and vomiting induced by GLP-1 receptor agonists—a common side effect impacting adherence in the rapidly growing obesity and diabetes treatment landscape.
Vanda anticipates launching NEREUS™ for the prevention of vomiting induced by motion in the coming months and remains committed to expanding its therapeutic potential across indications driven by substance P-mediated pathways.
