US FDA Clears Vanda Pharma’s Motion Sickness Drug

The U.S. health agency authorized Vanda Pharmaceuticals’ medication on Tuesday to prevent motion-induced vomiting, making it the first treatment for the ailment to be approved in almost 40 years.

In the upcoming months, the business plans to introduce the medication, Nereus, targeting patients who experience frequent or severe motion sickness during travel and daily activities.

When engaging in activities like driving, flying, or boating, confused signals from the eyes, inner ear, and body sensors might cause motion-induced vomiting, leading to discomfort and reduced quality of life for millions worldwide.

The medication, also known as tradipitant, dramatically decreased vomiting in two late-stage trials involving 681 patients, which served as the basis for the U.S. Food and Drug Administration’s clearance.

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Clinical Effectiveness and FDA Approval Basis

It functions by blocking a brain receptor associated with nausea and vomiting, offering a novel mechanism compared to existing motion sickness therapies.

“Sales of tradipitant alone in this indication may exceed $100 million annually at peak in the U.S. alone,” stated Raghuram Selvaraju, an analyst at H.C. Wainwright, highlighting strong commercial potential.

The prescription scopolamine patch from Viatris, Transderm Scop, Bonine from WellSpring Pharmaceutical, and Dramamine from Prestige Consumer Healthcare are further approved therapies to avoid motion sickness, though many patients report limited effectiveness or side effects.

Because motion sickness is classified as a chronic disease, the FDA initially put a partial clinical hold on Vanda’s tradipitant in December 2018, claiming the need to conduct further six-month chronic toxicity studies in dogs.

Regulatory History and Broader Development Plans

On December 4, the agency removed the research requirement and declared motion sickness to be an urgent disease, lifting the clinical hold and clearing the path for approval.

In 2012, Vanda received a license from Eli Lilly to test tradipitant for several conditions, such as motion sickness, gastroparesis, a gastrointestinal condition, and nausea brought on by some diabetes medications, signaling broader long-term development opportunities for the drug.