Vanda Pharmaceuticals announced that the US 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. 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 recognised as a factor affecting military operational readiness.

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

The efficacy of NEREUS is supported by robust data from three pivotal clinical trials—two phase III 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 percent with NEREUS versus 44.3 percent with placebo (p<0.0001).1 In Motion Serifos (n=316), vomiting rates were 10.4-18.3 percent with NEREUS versus 37.7 percent with placebo (p≤0.0014), representing risk reductions of over 50.2 percent. Across the pivotal programme, NEREUS consistently demonstrated significant reductions in vomiting and a favourable safety profile consistent with acute use.

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 characterised 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.

The company 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.