Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) shares are trading higher Wednesday after the company announced it received FDA approval of NEREUS for the prevention of vomiting induced by motion.
- Vanda Pharmaceuticals shares are testing new highs. Why is VNDA stock breaking out?
Trial Results Highlight NEREUS Efficacy
Vanda said the FDA approved NEREUS (tradipitant), an oral neurokinin-1 (NK-1) receptor antagonist, for the prevention of vomiting induced by motion. The approval marks the first new pharmacologic treatment for motion sickness in more than 40 years, according to the company.
The FDA decision was supported by data from three clinical studies, including two Phase 3 real-world provocation trials conducted on boats, Motion Syros and Motion Serifos, as well as an additional supporting study. All trials enrolled participants with documented histories of motion sickness.
In the Motion Syros trial, vomiting incidence ranged from 18.3% to 19.5% among patients treated with NEREUS, compared with 44.3% in the placebo group. In the Motion Serifos study, vomiting rates ranged from 10.4% to 18.3% with NEREUS versus 37.7% with placebo. The company said both studies met statistical significance.
Vanda said NEREUS demonstrated consistent reductions in vomiting across the clinical program and showed a favorable safety profile aligned with acute use.
The company noted that motion sickness affects a substantial portion of the population and has historically impacted military operational readiness. Vanda said the approval validates the drug’s pharmacological profile targeting substance P and NK-1 receptors involved in nausea and vomiting.
Vanda said it expects to launch NEREUS for the prevention of vomiting induced by motion in the coming months. The company is also advancing tradipitant in clinical development for other indications involving nausea and vomiting, including gastroparesis and GLP-1 receptor agonist-induced nausea and vomiting.
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VNDA Price Action: At the time of writing, Vanda shares are trading 27.45% higher at $8.95, according to data from Benzinga Pro.
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