Tradipitant, a novel NK-1 receptor antagonist, was proven effective at reducing the incidence and severity of nausea and vomiting in individuals with motion sickness.
The FDA has approved tradipitant (Nereus; Vanda Pharmaceuticals) for the prevention of vomiting induced by motion, marking the first novel pharmacologic treatment for motion sickness in over 40 years. The approval, announced in a news release from Vanda Pharmaceuticals, represents a major advancement in the management of motion sickness.1
Results from 2 pivotal phase 3 clinical trials and an additional supporting study supported tradipitant’s approval. Each of the pivotal trials (Motion Syros, NCT04327661; Motion Serifos, NCT05903924) was real-world provocation in nature and was conducted on boats.2-5
In Motion Syros (n = 365), adults with a history of motion sickness were randomized 1:1:1 to receive 180 mg tradipitant (n = 120), 85 mg tradipitant (n = 123), or placebo (n = 122). Vomiting and nausea symptoms were evaluated utilizing questionnaires every 30 minutes during the 4-hour trips at sea.2
Patients receiving tradipitant experienced significantly lower incidences of vomiting compared with the placebo across all boat trips (170 mg tradipitant = 18.3%, 85 mg tradipitant = 19.5%, placebo = 44.3%). Furthermore, tradipitant prevented severe nausea and vomiting compared with participants taking placebo (tradipitant = 18.03%, placebo = 37.70%; P < .0001).2
Motion Serifos investigators again compared 2 doses of tradipitant with placebo, with 316 participants who traveled by boat under varying sea conditions. Patients were randomized to receive 170 mg tradipitant (n = 106), 85 mg tradipitant (n = 104), and placebo (n = 106). The primary study end point was the effect of the 170 mg dose on vomiting.4
Study findings indicated that 10.4% of the 170 mg tradipitant group and 18.3% of the 85 mg tradipitant group experienced vomiting, compared with 37.7% of the placebo group (P = .00002 and P = .0014, respectively). Severe vomiting and nausea occurred in 13.3% of tradipitant recipients and 33.0% of placebo recipients (P = .00003). The data affirmed tradipitant’s effectiveness and bolstered support for its approval.4
Critically, tradipitant demonstrated consistent and favorable safety indications when used acutely.1
When an individual experiences motion sickness, the eyes, inner ear, and body send conflicting messages in response to movement while the body remains still. This can occur during movement in common modes of travel, like cars or planes. Symptoms can appear slowly or all at once and include dizziness, fatigue, headache, and nausea and vomiting. The condition most often impacts children aged 2 through 12, but adults can experience it as well. Across the United States, roughly 65 to 78 million individuals are afflicted Although most cases are mild and resolve easily without treatment, a major portion of individuals can experience severe, recurrent symptoms that impact quality of life.1,6
Specifically, motion sickness among military service members has been recognized as a gap in troop readiness. Since World War II, the condition was elevated to a strategic imperative to address and has prompted significant early research into antiemetic therapies to ensure operational readiness during troop deployments. Tradipitant could offer a revolutionary new treatment option for service members who experience motion sickness while eliminating a concern surrounding troop readiness.1
Tradipitant is a potent and selective antagonist of neurokinin-1 (NK-1) that prevents the activation of NK-1 receptors in the central nervous system, which can be the source of nausea and vomiting with motion sickness. By directly addressing the NK-1 pathway, tradipitant offers a more significant reduction in motion sickness symptoms, providing patients whose condition is inadequately controlled by existing therapeutic options a new avenue for relief.1
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