Smooth sailing for Vanda’s tradipitant in late-stage motion-sickness study
Clinical ResultPhase 3AcquisitionNDADrug Approval
Vanda Pharmaceuticals on Wednesday reported positive findings from a real-world Phase III trial demonstrating the effectiveness of the neurokinin-1 receptor (NK-1R) antagonist tradipitant in preventing vomiting associated with motion sickness, consistent with results from two earlier studies.
The Motion Serifos trial enrolled 316 participants with a history of motion sickness who were, randomised to receive either tradipitant 170mg, 85mg, or placebo during 20 boat trips in the US under varied sea conditions. The study’s primary endpoint was the effect of tradipitant 170mg on vomiting, while key secondary goals included the effect of the 85mg dose on vomiting and its ability to prevent severe nausea and vomiting.
Results showed that the higher dose of tradipitant outperformed placebo — reducing the risk of vomiting by over 70% — whereas the lower dose cut the risk by over 50% compared with placebo. Moreover, both tradipitant doses showed significant effectiveness in preventing severe nausea and vomiting, with 13.3% of participants affected in the tradipitant groups versus 33.0% in the placebo arm.
With approximately 30% of the general population susceptible to motion sickness, the drug represents a significant market opportunity for Vanda, which is eyeing an FDA filing in the fourth quarter. The company noted that if approved, tradipitant would be the first motion-sickness medication to hit the US market in over 40 years, since the transdermal scopolamine patch in 1979.
Tradipitant, which was acquired from Eli Lilly in 2012 for an initial license fee of just $1 million, is also being developed for the treatment of symptoms of gastroparesis, with a filing under review by the FDA. The agency is due to issue a decision on the application by September 18.
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