Vanda Pharmaceuticals Wins FDA Approval for New Motion Sickness Drug After Four Decades

Vanda Pharmaceuticals has received approval from the U.S. Food and Drug Administration (FDA) for its drug tradipitant, branded as Nereus, marking the first new FDA-approved treatment for motion-induced vomiting in more than 40 years. The company announced that it plans to launch the drug in the United States in the coming months, a move that could significantly change the treatment landscape for motion sickness.

Motion-induced vomiting, often referred to as motion sickness, occurs when the brain receives conflicting signals from the eyes, inner ear, and body sensors. This condition commonly affects people during travel activities such as boating, driving, or flying and has long relied on older treatment options with limited innovation.

The FDA’s approval of Nereus was supported by two late-stage clinical trials involving a total of 681 patients. Results from these studies showed that tradipitant significantly reduced episodes of vomiting compared to placebo. The drug works by blocking a specific brain receptor associated with nausea and vomiting, offering a targeted and modern approach to treatment.

According to H.C. Wainwright analyst Raghuram Selvaraju, peak annual sales of tradipitant for motion sickness alone could exceed $100 million in the U.S., highlighting its strong commercial potential. Currently available motion sickness treatments include Viatris’ scopolamine patch Transderm Scop, WellSpring Pharmaceutical’s Bonine, and Prestige Consumer Healthcare’s Dramamine, many of which have been on the market for decades.

Tradipitant’s regulatory journey faced challenges in the past. In December 2018, the FDA placed a partial clinical hold on the drug, requesting additional long-term toxicity studies in dogs after classifying motion sickness as a chronic condition. However, the agency reversed its stance, reclassifying motion sickness as an acute condition and lifting the clinical hold on December 4, eliminating the need for further studies.

Vanda licensed tradipitant from Eli Lilly in 2012 and continues to study the drug for multiple indications, including gastroparesis and nausea linked to certain diabetes medications. The company has not yet disclosed pricing details for Nereus.