Vanda Pharmaceuticals has 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 for motion sickness in more than four decades, representing a significant advancement in the understanding and management of this debilitating physiologic response.
"This approval underscores the strong scientific evidence in the antiemetic effects of NEREUS in motion sickness," said Dr Mihael H. Polymeropoulos, President, CEO and Chair of the Board of Vanda Pharmaceuticals.
"For the first time in more than 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 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, vomiting incidence was 18.3-19.5% with NEREUS versus 44.3% with placebo.
In Motion Serifos, vomiting rates were 10.4-18.3% with NEREUS versus 37.7% with placebo, representing risk reductions of more than 50-70%.
Across the programme, NEREUS consistently demonstrated significant reductions in vomiting and a favourable safety profile consistent with acute use.
Approximately 25-30% of adults experience motion sickness symptoms during common travel modes such as cars, planes, or boats.
While most cases are mild, an estimated 5-15% of the population experiences severe, recurrent symptoms that can significantly impact quality of life.
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, the 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 characterised by delayed gastric emptying and persistent nausea/vomiting.
The company is also investigating the use of tradipitant 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.