Vanda Pharmaceuticals has received approval from the FDA for Nereus (tradipitant), an oral drug that prevents motion-induced vomiting.
A neurokinin-1 (NK-1) receptor antagonist, Nereus is the first motion sickness treatment to receive FDA approval in more than 40 years.
The approval is based on two phase 3 real-world provocation studies carried out on boats along with a supporting study. All three clinical trials used patients with histories of motion sickness. The vomiting incidence when taking the drug was between 10.4% and 19.5% compared to between 37.7% and 44.4% with the placebo, which was a risk reduction of between 50% and 70%.
The drug is also in clinical development for various other indications, including gastroparesis and prevention of nausea and vomiting when taking GLP-1 agonists. In September 2024, the FDA declined to approve the drug for the treatment of symptoms in gastroparesis, handing Vanda a complete response letter.
Vanda picked up the global development rights to tradipitant from Eli Lilly in 2012. Under the terms of the deal, Vanda paid an initial $1 million, with Lilly eligible to receive additional payments up to $99 million based upon achievement of specified development and commercialization milestones.