Vanda Pharmaceuticals said Tuesday that U.S. regulators have authorized a new medication designed to prevent vomiting caused by motion, ending a decades-long gap without newly approved treatments for the condition.
The drug, branded Nereus and known generically as tradipitant, is expected to be introduced to the U.S. market in the coming months, the company said.
Motion-related vomiting occurs when the brain receives conflicting input from the eyes, inner ear and body movement sensors, commonly during travel by car, air or sea. Treatment options for the condition have remained largely unchanged for many years.
The Food and Drug Administration based its decision on results from two late-stage clinical trials involving 681 patients. In those studies, patients receiving tradipitant experienced significantly fewer vomiting episodes than those given a placebo.
Tradipitant works by blocking a specific receptor in the brain associated with nausea and vomiting, according to the company.
Analysts said the approval could open a meaningful commercial opportunity. H.C. Wainwright analyst Raghuram Selvaraju estimated that U.S. sales of the drug for this indication could surpass $100 million annually at peak.
Current options for preventing motion sickness include a prescription scopolamine patch sold by Viatris, as well as over-the-counter medications such as Bonine and Dramamine.
Vanda’s development of tradipitant faced regulatory delays after the FDA imposed a partial clinical hold in late 2018, citing concerns that motion sickness had been classified as a chronic condition requiring additional long-term toxicity studies. That hold was lifted earlier this month after the agency determined the condition should be treated as acute, removing the need for the additional studies.
Vanda licensed tradipitant from Eli Lilly in 2012 and has evaluated the compound for several potential uses, including motion-related vomiting, gastroparesis and nausea associated with certain diabetes medications.
The company did not disclose pricing details and did not immediately respond to a request for comment on its commercialization plans.
