Vanda Ends 40-12 months Movement Illness Drug Drought with FDA Approval for Nereus

The FDA has authorised Vanda Prescribed drugs’ tradipitant for the prevention of vomiting induced by movement.

The corporate filed for FDA approval after linking the oral neurokinin-1 receptor antagonist, which Vanda will promote as Nereus, to important reductions in vomiting in two Part III real-world provocation research carried out on boats. In a single trial, vomiting incidence was 18.3% to 19.5% with Nereus versus 44.3% with placebo. Vomiting charges have been 10.4% to 18.3% with Nereus versus 37.7% on placebo within the second research.

Vanda stated the approval marks the primary time in over 40 years {that a} new pharmacologic remedy for movement illness has come to market. Nereus will compete with dramamine, an over-the-counter antihistamine drug that forestalls and treats movement illness signs together with nausea, vomiting and dizziness. Jefferies analysts recognized a element of the approval that might differentiate Nereus.

“Encouragingly, Nereus’ label is for the prevention of vomiting attributable to movement, relatively than the signs of movement illness (e.g. nausea, vomiting, and dizziness) like dramamine,” the analysts stated in a notice to buyers.

The label permits sufferers to take Nereus round 60 minutes earlier than an occasion anticipated to trigger vomiting induced by movement. Sufferers must take the medication on an empty abdomen, that means not less than one hour earlier than or two hours after a full meal, however in any other case analysts stated the “entrance web page label appears to be like clear/easy.”

Vanda’s evaluation of the market alternative for Nereus consists of two to 3 million U.S. sufferers who take dramamine each month, the analysts stated. The shortage of innovation within the movement illness drug area means there could also be some pent-up demand for Nereus.

“We envision a gradual launch curve as consciousness builds over time, with some contribution from sufferers who’ve been ready for a substitute for current therapies,” the analysts stated. “A modest penetration amongst dissatisfied customers or sufferers who at present keep away from journey (as a result of insufficient symptom management) might drive significant gross sales in idea.”

Vanda is but to share the checklist worth for Nereus, however Jefferies analysts count on a premium over current OTC remedies. The corporate hopes to be properly ready for launch forward of the 2026 summer time season, the analysts stated, and plans to concentrate on digital promoting and direct-to-consumer outreach relatively than constructing a big prescriber‑targeted gross sales drive.

The analysts’ overview of the launch plan aligns with feedback by Vanda CEO Mihael Polymeropoulos. On an earnings name in October 2025, Polymeropoulos described the technique for each Nereus and jet lag drug Hetlioz.

“We’re creating a fairly elaborate technique that can develop into very consumer-centric, specializing in concierge service for supplying the drug to each of them,” Polymeropoulos stated. “Our latest experiences with direct-to-consumer campaigns, but additionally the elevation of brand name consciousness of the corporate, are going to be crucial and have been strategically designed to be in place prematurely of these launches.”

The FDA might rule on Hetlioz in jet lag by Jan. 7. The back-to-back regulatory actions comply with the creation of a collaborative framework to resolve disputes between the FDA and Vanda, which sued the company in April amid rejections, a partial maintain and different setbacks. The FDA lifted the partial maintain on tradipitant final month.

Vanda’s approval was considered one of a clutch of authorizations over the vacation interval. The FDA additionally authorised Agios Prescribed drugs’ Aqvesme for the remedy of anemia in adults with alpha- or beta-thalassemia, and expanded the labels of Roche’s most cancers drug Lunsumio and Boehringer Ingelheim’s pulmonary fibrosis medication Jascayd.