Vanda Pharmaceuticals Inc (Nasdaq:VNDA), a US-based global biopharmaceutical company, announced on Tuesday that it has received approval from the US Food and Drug Administration (FDA) for NEREUS (tradipitant), an oral neurokinin-1 (NK-1) receptor antagonist, for the prevention of vomiting induced by motion.
This approval marks the first new pharmacologic treatment in motion sickness in over four decades, the company said.
The product's efficacy is supported by positive data from three pivotal clinical trials -- two Phase 3 real-world provocation studies carried out on boats (Motion Syros and Motion Serifos) and one additional supporting study -- with participants who had documented histories of motion sickness.
Vanda is planning to launch NEREUS in the coming months.
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