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Vanda Pharmaceuticals Announces FDA Approval of NEREUS™ (tradipitant) for the Prevention of Vomiting Induced by Motion: A Historic Scientific Milestone in the Prevention of Motion Sickness
Prnewswire· 2025-12-30 23:13
Core Viewpoint - Vanda Pharmaceuticals has received FDA approval for NEREUS™ (tradipitant), marking the first new pharmacologic treatment for motion sickness in over 40 years, which is a significant advancement in managing this condition that affects a large portion of the population [1][2] Company Overview - Vanda Pharmaceuticals is a global biopharmaceutical company focused on developing innovative therapies to address unmet medical needs and improve patient lives [9] - The company is advancing tradipitant for additional indications, including gastroparesis and nausea/vomiting induced by GLP-1 receptor agonists [6][10] Product Details - NEREUS™ is an oral neurokinin-1 (NK-1) receptor antagonist approved for the prevention of vomiting induced by motion in adults [11] - The drug's mechanism of action involves potent and selective antagonism of NK-1 receptors, addressing the sensory conflict that triggers nausea and vomiting [5] Clinical Evidence - The efficacy of NEREUS™ is supported by data from three pivotal clinical trials, showing significant reductions in vomiting incidence: - In Motion Syros (n=365), vomiting incidence was 18.3–19.5% with NEREUS™ compared to 44.3% with placebo (p<0.0001) - In Motion Serifos (n=316), vomiting rates were 10.4–18.3% with NEREUS™ versus 37.7% with placebo (p=0.0014), indicating risk reductions of over 50–70% [3] Market Context - Motion sickness affects approximately 25–30% of adults in the U.S., equating to roughly 65–78 million people, with up to one-third of individuals globally being highly susceptible [5] - A significant segment of the population experiences severe symptoms that can greatly impact quality of life, with tens of millions seeking pharmacologic treatment annually [5] Future Prospects - Vanda anticipates launching NEREUS™ in the coming months and is committed to expanding its therapeutic potential across indications driven by substance P-mediated pathways [7]