Vanda's Motion Sickness Drug Nereus Now Available; Phase 3 GLP-1 Study Underway

Nereus (tradipitant), a substance P/neurokinin-1 receptor antagonist, is now available by prescription in retail pharmacies nationwide and directly through nereus.us for the prevention of vomiting induced by motion in adults, according to manufacturer Vanda Pharmaceuticals. The product is supplied in 85 mg capsules. Vanda has also initiated a placebo-controlled phase 3 trial, dubbed Thetis, evaluating Nereus in patients receiving a high dose of a GLP-1 agonist, with topline results expected in the fourth quarter of this year.

The FDA approval of Nereus was supported by data from phase 3 clinical trials, including two conducted on boats, that showed the treatment reduced the incidence of vomiting compared with placebo during sea-based travel in adult participants with a history of motion sickness. The recommended dosage is 85 mg or 170 mg as a single oral dose approximately 60 minutes before an event expected to cause vomiting induced by motion. Patients should take Nereus on an empty stomach, at least 1 hour prior to or 2 hours after a full meal, and the lowest effective dose should be used. The maximum dosage in a 24-hour period is a single dose of 85 mg or 170 mg. The safety of Nereus beyond more than 90 doses has not been established in clinical trials.

The most common adverse reactions associated with Nereus include somnolence, headache, and fatigue. The drug may impair the mental or physical abilities required to drive or operate heavy machinery, and certain concomitant medications, including other central nervous system depressants and strong CYP3A4 inhibitors, may increase this effect.

In the phase 2 trial that preceded Thetis, patients were pre-treated with Nereus or placebo before the addition of a 1 mg injection of Novo Nordisk's Wegovy. Results showed that 29% of patients on Nereus plus Wegovy experienced vomiting compared to 59% of those on placebo plus Wegovy, a 50% relative reduction. Among the 106 patients in the trial, the key secondary endpoint was also achieved, with 22% in the Nereus group experiencing vomiting and nausea compared to 48% in the placebo arm. The phase 3 Thetis trial's primary endpoint is the proportion of patients free from vomiting episodes.

Nereus is a neurokinin-1 (NK-1) receptor antagonist, a drug class used to prevent nausea and vomiting in patients who have had chemotherapy. Vanda's CEO stated in a release that GLP-1 receptor agonists offer significant benefits but vomiting and nausea can severely impact patient adherence and quality of life, and that Nereus has demonstrated potent antiemetic effects in prior clinical studies.