After 40 Years, USFDA Approves Vanda Pharma's Motion Sickness Drug Nereus

The U.S. Food and Drug Administration's approval was based on two late-stage studies with a total of 681 patients, in which the drug, also known as tradipitant, had significantly reduced vomiting.

It works by blocking a brain receptor linked ‌to ‍nausea and vomiting.

"Sales of tradipitant solely in this indication ‍could exceed $100 million annually at peak in the ‌U.S. alone," said H.C. Wainwright analyst Raghuram Selvaraju.

Other approved treatments to prevent motion sickness are Viatris' prescription scopolamine patch, Transderm Scop, WellSpring Pharmaceutical's Bonine and Prestige Consumer Healthcare's Dramamine.

The FDA had originally placed a partial clinical hold on Vanda's tradipitant in December 2018, citing the need for additional six-month ‍chronic toxicity studies in dogs due to the classification of motion sickness as a chronic condition.

The agency ‍lifted the ⁠clinical hold on ⁠December 4, calling motion sickness an acute condition and dropping the study requirement.

Vanda licensed tradipitant from Eli Lilly in 2012 and has been testing it for several uses, including motion sickness, a stomach disorder called gastroparesis, and nausea caused by certain diabetes drugs.

The company did not immediately respond to a Reuters request for a comment on the drug's pricing.