Vanda Pharmaceuticals has received approval from the U.S. Food and Drug Administration (FDA) for its drug tradipitant, which will be marketed as Nereus, for the prevention of vomiting caused by motion. This marks the first time in more than 40 years that a new pharmacological treatment for motion sickness has been introduced to the market.
The FDA’s decision follows two Phase III studies conducted by Vanda on boats, where Nereus showed a significant reduction in vomiting compared to placebo. In one trial, patients taking Nereus had a vomiting incidence between 18.3% and 19.5%, while those on placebo experienced a rate of 44.3%. In another study, rates were between 10.4% and 18.3% with Nereus versus 37.7% with placebo.
Nereus is expected to compete with dramamine, an over-the-counter antihistamine used to prevent and treat symptoms such as nausea, vomiting, and dizziness associated with motion sickness. Jefferies analysts noted a distinguishing aspect of Nereus’ approval: “Encouragingly, Nereus’ label is for the prevention of vomiting caused by motion, rather than the symptoms of motion sickness (e.g., nausea, vomiting, and dizziness) like dramamine,” they said in a note to investors.
Patients are advised to take Nereus about an hour before exposure to conditions likely to cause motion-induced vomiting and must do so on an empty stomach—either at least one hour before or two hours after eating a full meal. Analysts described the medication’s labeling as straightforward.
According to Vanda’s market analysis cited by Jefferies analysts, there are approximately two to three million people in the United States who use dramamine each month. The long period without innovation in this field may lead some patients to seek alternatives such as Nereus.
“We envision a steady launch curve as awareness builds over time, with some contribution from patients who have been waiting for an alternative to existing therapies,” said Jefferies analysts. “A modest penetration among dissatisfied users or patients who currently avoid travel (due to inadequate symptom control) could drive meaningful sales in theory.”
While Vanda has not disclosed pricing details for Nereus yet, Jefferies expects it will be priced higher than current over-the-counter treatments. The company aims to be ready for launch ahead of summer 2026 and plans marketing efforts focused on digital advertising and direct-to-consumer outreach instead of expanding its prescriber-focused sales force.
Vanda CEO Mihael Polymeropoulos commented on the company’s approach during an earnings call in October 2025: “We’re developing a quite elaborate strategy that will become very consumer-centric, focusing on concierge service for supplying the drug to both of them,” referring also to their jet lag drug Hetlioz. He added: “Our recent experiences with direct-to-consumer campaigns, but also the elevation of brand awareness of the company, are going to be very important and have been strategically designed to be in place in advance of those launches.”
The FDA is expected soon to make a decision regarding Hetlioz for jet lag treatment after recently resolving disputes between Vanda and the agency that included litigation earlier this year and lifting previous restrictions on tradipitant last month.
In addition to Vanda’s authorization over the holiday period, other recent FDA approvals include Agios Pharmaceuticals’ Aqvesme for anemia related to thalassemia and expanded indications for Roche’s Lunsumio cancer therapy and Boehringer Ingelheim’s Jascayd pulmonary fibrosis medication.
