Vanda Pharmaceuticals (NASDAQ:VNDA) has secured U.S. Food and Drug Administration approval for NEREUS™ (tradipitant), ending a four-decade drought in new pharmacological treatments for motion sickness.
The oral neurokinin-1 (NK-1) receptor antagonist is specifically indicated for the acute prevention of vomiting induced by motion in adults.
The approval, announced Tuesday, is underpinned by three pivotal trials that demonstrated a dramatic reduction in physical distress during travel.
In the "Motion Syros" study (n=365), vomiting incidence dropped to 18.3–19.5% among those taking NEREUS™, compared to 44.3% in the placebo group.
Similar results were mirrored in the "Motion Serifos" trial (n=316), where vomiting rates were as low as 10.4% versus 37.7% for placebo, representing a risk reduction of up to 70%.
The stock surged more than 20% in overnight trading following the news, as investors weighed the commercial potential of a drug targeting a condition that affects an estimated 25% of the U.S. population.
Analyst Raghuram Selvaraju of H.C. Wainwright suggested peak annual U.S. sales for this indication alone could exceed $100 million.
Vanda expects to launch NEREUS™ "in the coming months.
Beyond travel-induced illness, the company is aggressively pursuing the drug’s application for gastroparesis and as a treatment for nausea and vomiting induced by GLP-1 agonists, a rapidly growing segment of the weight-loss drug market.