Vanda Pharmaceuticals has received FDA approval for Nereus (tradipitant), an oral NK-1 receptor antagonist developed to prevent motion-induced vomiting.
The approval makes Nereus the first new pharmacologic treatment for motion sickness in more than four decades. Its efficacy is supported by three pivotal trials, including two phase 3 studies, according to a Dec. 30 news release.The drug significantly reduced the occurrence of vomiting in clinical trials compared to a placebo. In both studies, participants who took Nereus were far less likely to vomit than those who received a placebo, demonstrating the drug’s strong potential to prevent motion-induced symptoms.
Motion sickness affects an estimated 25% to 30% of adults in the U.S. — about 65 million to 78 million people — and up to one-third of individuals globally. The company said 5% to 15% of the population experiences severe, recurrent symptoms, and tens of millions seek medication each year.
Vanda said it plans to launch Nereus in the coming months and is continuing clinical development of tradipitant for additional indications.
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