Vanda Pharma Launches First New Motion Sickness Drug in 40 Years

The U.S. Food and Drug Administration (FDA) has approved Nereus (tradipitant), marking the first new pharmacological treatment for motion sickness in nearly four decades. This significant decision provides a sense of optimism for Vanda Pharma, especially as it comes after a previous setback when the FDA declined to approve tradipitant for delayed gastric emptying (gastroparesis) in 2022.

The approval for Nereus aims specifically at preventing vomiting induced by motion, a condition that affects a considerable portion of the population. According to Vanda’s estimates, between 25% and 30% of adults, or approximately 65–78 million people in the United States, experience symptoms of motion sickness while traveling by car, plane, boat, and other forms of transport. Although most cases are mild, around 15% of individuals suffer from severe and recurrent symptoms that can significantly diminish their quality of life.

The FDA’s recent decision comes after the agency lifted a partial clinical hold on tradipitant, agreeing that the drug’s potential use as an acute treatment for motion sickness eliminated the need for a lengthy six-month toxicity study. This improvement paves the way for clinical trials that may broaden its applications in the future.

Vanda Pharma expressed its satisfaction with the approval, stating that it represents “a significant advancement in the understanding and management of this debilitating physiologic response.” The company believes that Nereus could provide relief for individuals who find little comfort in existing therapies or who avoid traveling due to their severe symptoms.

Analysts anticipate that sales of Nereus could reach $100 million annually in the United States. The approval is based on two late-stage studies involving a total of 681 patients exposed to motion on boats, which demonstrated that the preventative use of tradipitant notably reduced vomiting incidents.

This regulatory green light offers Vanda an opportunity to enhance its sales growth. Currently, the company’s revenue is driven by several products, including Fanapt (iloperidone) for schizophrenia and bipolar disorder, Hetlioz (tasimelteon) for sleep disorders, and Ponvory (ponesimod) for multiple sclerosis. Together, these products generated $56 million in sales during the third quarter.

Additionally, Hetlioz is under review for treating jet lag disorder. This application, initially rejected by the FDA in 2019, was re-evaluated following a lawsuit filed by Vanda earlier this year. A new decision is expected by January 7, 2024.

As Vanda Pharma moves forward with Nereus, the company aims to address a long-standing issue affecting many travelers, potentially transforming the experience for those who suffer from motion sickness.