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biotech/news//U.S. News & World Report
Vanda Pharmaceuticals expects to launch the drug, Nereus, in the coming months.
Nereus is the first drug approved for motion-induced vomiting in over 40 years.
KEY POINTS
FDA lifted its partial clinical hold after reclassifying motion sickness as an acute condition.
Approval was based on two late-stage studies with 681 patients showing significant reductions in vomiting.
Vanda licensed tradipitant from Eli Lilly in 2012 for multiple potential indications beyond motion sickness.
Dec 30 (Reuters) - Vanda Pharmaceuticals said on Tuesday its drug for the prevention of motion-induced vomiting was approved by the U.S. health regulator, becoming the first treatment for the condition to receive the nod in more than 40 years.
The company expects to launch the drug, Nereus, in the coming months.
Motion-induced vomiting is a response triggered by mixed signals between the eyes, inner ear and body sensors, during activities such as boating, driving or flying.
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.
(Reporting by Siddhi Mahatole and Puyaan Singh in Bengaluru; Editing by Shilpi Majumdar)