Jefferies analysts envision a steady launch curve that could ultimately drive meaningful sales from people who are dissatisfied with existing treatments.
The FDA has approved Vanda Pharmaceuticals’ tradipitant for the prevention of vomiting induced by motion.
The company filed for FDA approval after linking the oral neurokinin-1 receptor antagonist, which Vanda will sell as Nereus, to significant reductions in vomiting in two Phase III real-world provocation studies conducted on boats. In one trial, vomiting incidence was 18.3% to 19.5% with Nereus versus 44.3% with placebo. Vomiting rates were 10.4% to 18.3% with Nereus versus 37.7% on placebo in the second study.
Vanda said the approval marks the first time in over 40 years that a new pharmacologic treatment for motion sickness has come to market. Nereus will compete with dramamine, an over-the-counter antihistamine drug that prevents and treats motion sickness symptoms including nausea, vomiting and dizziness. Jefferies analysts identified a detail of the approval that could differentiate Nereus.
“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,” the analysts said in a note to investors.
The label permits patients to take Nereus around 60 minutes before an event expected to cause vomiting induced by motion. Patients need to take the medicine on an empty stomach, meaning at least one hour before or two hours after a full meal, but otherwise analysts said the “front page label looks clean/simple.”
Vanda’s assessment of the market opportunity for Nereus includes two to three million U.S. patients who take dramamine every month, the analysts said. The lack of innovation in the motion sickness drug field means there may be some pent-up demand for 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,” the analysts said. “A modest penetration among dissatisfied users or patients who currently avoid travel (due to inadequate symptom control) could drive meaningful sales in theory.”
Vanda is yet to share the list price for Nereus, but Jefferies analysts expect a premium over existing OTC treatments. The company hopes to be well prepared for launch ahead of the 2026 summer season, the analysts said, and plans to focus on digital advertising and direct-to-consumer outreach rather than building a large prescriber‑focused sales force.
The analysts’ overview of the launch plan aligns with comments by Vanda CEO Mihael Polymeropoulos. On an earnings call in October 2025, Polymeropoulos described the strategy for both Nereus and jet lag drug Hetlioz.
“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,” Polymeropoulos said. “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 could rule on Hetlioz in jet lag by Jan. 7. The back-to-back regulatory actions follow the creation of a collaborative framework to resolve disputes between the FDA and Vanda, which sued the agency in April amid rejections, a partial hold and other setbacks. The FDA lifted the partial hold on tradipitant last month.
Vanda’s approval was one of a clutch of authorizations over the holiday period. The FDA also approved Agios Pharmaceuticals’ Aqvesme for the treatment of anemia in adults with alpha- or beta-thalassemia, and expanded the labels of Roche’s cancer drug Lunsumio and Boehringer Ingelheim’s pulmonary fibrosis medicine Jascayd.
