Item 1 of 2 Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS\/Andrew Kelly<\/p>\n
[1\/2]<\/b>Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS\/Andrew Kelly Purchase Licensing Rights, opens new tab<\/a>Dec 30 (Reuters) – Vanda Pharmaceuticals (VNDA.O), opens new tab<\/a> 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.<\/p>\n The company expects to launch the drug, Nereus, in the coming months.<\/p>\n Sign up here.<\/a><\/p>\n 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.<\/p>\n 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.<\/p>\n It works by blocking a brain receptor linked to nausea and vomiting.<\/p>\n “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.<\/p>\n Other approved treatments to prevent motion sickness are Viatris’ (VTRS.O), opens new tab<\/a> prescription scopolamine patch, Transderm Scop, WellSpring Pharmaceutical’s Bonine and Prestige Consumer Healthcare’s (PBH.N), opens new tab<\/a> Dramamine.<\/p>\n 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.<\/p>\n The agency lifted the clinical hold on December 4, calling motion sickness an acute condition and dropping the study requirement.<\/p>\n Vanda licensed tradipitant from Eli Lilly (LLY.N), opens new tab<\/a> 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.<\/p>\n The company did not immediately respond to a Reuters request for a comment on the drug’s pricing.<\/p>\n Reporting by Siddhi Mahatole and Puyaan Singh in Bengaluru; Editing by Shilpi Majumdar<\/p>\n Our Standards: The Thomson Reuters Trust Principles., opens new tab<\/a><\/p>\n