Vanda Pharmaceuticals Inc. (Vanda) has announced the FDA approval of 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.
The efficacy of Nereus™ is supported by robust data from three pivotal clinical trials. In the Motion Syros trial (n=365), vomiting incidence was 18.3–19.5% with Nereus™ versus 44.3% with placebo (p<0.0001). In the Motion Serifos trial (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%. Across the pivotal program, Nereus™ consistently demonstrated significant reductions in vomiting and a favorable safety profile consistent with acute use.
Motion sickness remains prevalent in civilian life, with approximately 25–30% of adults—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. While most cases are mild, an estimated 5–15% of the population experiences severe, recurrent symptoms that can significantly impact quality of life.
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.
Nereus™ is licensed by Vanda from Eli Lilly and Company and is approved for the acute prevention of vomiting induced by motion in adults. In placebo-controlled clinical trials, somnolence (6%, 12%) and fatigue (6%, 8%) were adverse reactions reported in subjects who took a single dose of 85 mg or 170 mg Nereus™, respectively. The safety and effectiveness of Nereus™ have not been established in pediatric patients.
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. Today the company's shares have moved 1.5% to a price of $6.77. Check out the company's full 8-K submission here.
