Vanda Pharmaceuticals has reported positive outcomes from its second Phase III clinical trial of tradipitant, aimed at treating motion sickness.
Dubbed Motion Serifos, the double-blind, randomised, multicentre, placebo-controlled trial involved 316 participants with a history of motion sickness.
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The study was conducted on boats in the coastal waters of the US.
Participants embarked on boat trips under varied sea conditions were given either 170mg or 85mg tradipitant, or placebo.
The impact of tradipitant in preventing vomiting was the trial’s primary endpoint.
Key secondary endpoints included the impact of the 85mg dose on vomiting and the drug’s ability to prevent severe nausea and vomiting.
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By GlobalDataThe study’s findings reinforced previous results from two trials, demonstrating tradipitant’s effectiveness in preventing severe nausea and vomiting associated with motion sickness.
Results also showed that both doses of tradipitant were significantly more effective than the placebo.
In the trial, only 10.4% and 18.3% of the subjects reported vomiting on the 170mg and 85mg doses, respectively, compared to 37.7% in the placebo arm.
This translates to a vomiting risk reduction by over 70% for the 170mg group and more than 50% for the 85mg group.
Furthermore, both doses of tradipitant were successful in achieving the secondary endpoint of preventing severe nausea and vomiting.
With these encouraging results, Vanda anticipates filing a new drug application for tradipitant, for prevention of vomiting induced by motion, with the US Food and Drug Administration in the fourth quarter of this year.
In December 2022, Vanda Pharmaceuticals reported data from a Phase II clinical trial of VQW-765 for the treatment of acute performance anxiety.
The placebo-controlled, randomised, multicentre, double-blind assessed VQW-765’s efficacy and safety in performance anxiety patients.
