Results from a phase III study of tradipitant in motion sickness

The Phase III study was conducted in real-world conditions on boats in the coastal waters of the United States (U.S.).The Motion Syros study was a multicenter, randomized, double-blind, placebo-controlled study where 365 participants embarked on boat trips under varied sea conditions and received tradipitant 170 mg, tradipitant 85 mg, or placebo. Study participants had a prior history of motion sickness and were distributed across thirty-four boat trips that took place between November 2021 and April 2023. Sea conditions and participant evaluation of the symptoms of motion sickness were recorded for each trip. The primary endpoint of the study was the effect of tradipitant on vomiting induced by motion sickness.

Both 170 mg and 85 mg tradipitant doses were shown to be superior to placebo in preventing vomiting with only 18.3% and 19.5% of participants experiencing vomiting on tradipitant 170 mg and 85 mg respectively, as compared to 44.3% of participants on placebo (p < 0.0001 for both). Motion sickness remains an unmet need as various pharmacological and non-pharmacological interventions suffer from low efficacy, substantial side effects, or both.

The FDA has not approved a new medication for motion sickness in over forty years, since the approval of scopolamine, a transdermal patch placed behind the ear, in 1979. Vanda plans to continue the motion sickness clinical program and pursue FDA approval upon completion of additional efficacy and safety studies.