FDA Approves Vanda's Nereus, Ending 40-Year Drought in Motion Sickness Treatments

The U.S. Food and Drug Administration (FDA) has granted approval to Vanda Pharmaceuticals' Nereus (tradipitant), marking the first new pharmacologic treatment for motion sickness in over four decades. This milestone approval comes amid a flurry of regulatory actions in the pharmaceutical industry, signaling potential shifts in treatment landscapes for various conditions.

Nereus: A New Era in Motion Sickness Prevention

Vanda's oral neurokinin-1 receptor antagonist, Nereus, has been approved specifically for the prevention of vomiting induced by motion. The drug demonstrated significant efficacy in two Phase III real-world provocation studies conducted on boats, with vomiting incidence reduced to 18.3% to 19.5% with Nereus, compared to 44.3% with placebo in one trial, and 10.4% to 18.3% versus 37.7% in the second study.

Jefferies analysts note that Nereus' label distinguishes it from existing over-the-counter options like dramamine by focusing on vomiting prevention rather than broader motion sickness symptoms. The drug's administration guidelines allow patients to take Nereus approximately 60 minutes before an event expected to cause motion-induced vomiting, on an empty stomach.

Market Potential and Launch Strategy

Vanda estimates a substantial market opportunity, with two to three million U.S. patients currently using dramamine monthly. The company plans a consumer-centric launch strategy, emphasizing digital advertising and direct-to-consumer outreach rather than building a large prescriber-focused sales force.

Mihael Polymeropoulos, Vanda's CEO, outlined the approach: "We're developing a quite elaborate strategy that will become very consumer-centric, focusing on concierge service for supplying the drug to both [Nereus and jet lag drug Hetlioz]."

While the list price for Nereus has not been disclosed, analysts expect it to be priced at a premium compared to existing OTC treatments. The company aims to be well-prepared for launch ahead of the 2026 summer season.

Additional FDA Approvals and Label Expansions

The FDA's recent actions extend beyond Vanda's success. Agios Pharmaceuticals received approval for Aqvesme, a treatment for anemia in adults with alpha- or beta-thalassemia. Additionally, the agency expanded the labels of Roche's cancer drug Lunsumio and Boehringer Ingelheim's pulmonary fibrosis medicine Jascayd.

These developments, occurring over the holiday period, reflect ongoing advancements across various therapeutic areas in the pharmaceutical industry.