FDA APPROVES FIRST NEW DRUG FOR MOTION SICKNESS IN 40 YEARS
February 2026
The FDA recently approved tradipitant (Nereus®) for the prevention of vomiting induced by motion sickness in adults. It is the first drug approved for motion sickness in over 40 years. Tradipitant is a substance P/neurokinin-1 (NK-1) receptor antagonist, which works by blocking the effects of substance P on the vomiting center in the brain. Motion sickness is a normal physiologic response that can affect almost anyone with a functional vestibular system. Peak susceptibility occurs between ages 7 and 12 years and generally declines through adulthood. Women are affected more than men, and twin studies suggest heritability accounts for 55–70% of the variation in susceptibility.
The efficacy of tradipitant was evaluated in two randomized, double-blind, placebo-controlled studies. In both trials, adults with a history of motion sickness were randomized 1:1:1 to a single dose of Nereus 85 mg, 170 mg, or placebo approximately 60 minutes before a boat trip lasting 2 to 5 hours. The primary endpoint was the percentage of subjects with vomiting during the trip. In Study 1, vomiting occurred in 20% (85 mg), 18% (170 mg), and 44% (placebo); treatment differences versus placebo were −25% (95% CI −36% to −14%) for 85 mg and −26% (−37% to −15%) for 170 mg. In Study 2, vomiting occurred in 18%, 10%, and 38%, respectively; differences were −19% (−31% to −8%) and −27% (−38% to −16%). A secondary endpoint of worst nausea score did not differ significantly from placebo in either study. The most common adverse reactions (incidence ≥5%) were somnolence (12%), headache (10%), and fatigue (8%). Strong CYP3A4 inhibitors may increase tradipitant exposure. The recommended dose is 85 mg or 170 mg as a single oral dose about 60 minutes before motion, on an empty stomach, with a maximum of one dose per 24 hours.
Prescription options for motion sickness have included the antimuscarinic scopolamine (transdermal patch) and the sedating antihistamine promethazine. Over-the-counter options include dimenhydrinate and meclizine. Tradipitant offers a new option with a new mechanism; however, it is a new drug and significantly more expensive than older therapies.
