Tradipitant Effective in Preventing Motion Sickness

About this update from Vanda Pharmaceuticals Inc.

[{"type":"text","content":"WASHINGTON, July 16, 2019 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that tradipitant, a neurokinin-1 receptor antagonist, was effective in treating motion sickness in a clinical study conducted in the Pacific Ocean.\nThe clinical efficacy results reported today are from the Motion Sifnos Phase II clinical study. In this study, 126 people with a prior history of motion sickness were subjected to sea travel in the Pacific Ocean. Study participants were randomized to receive either tradipitant or placebo in a blinded fashion.\nThe study had two primary endpoints: percentage of participants vomiting, and Motion Sickness Severity Scale (MSSS) Worst score.\nIn the overall population, a significantly higher percentage of participants experienced vomiting in the placebo arm as compared to the tradipitant arm, 39.7% versus 17.5% respectively, p value = 0.0039. The MSSS Worst score endpoint also favored tradipitant, but the difference did not reach statistical significance, 3.75 versus 3.4, p value = 0.293 (Table 1).\nAn exploratory analysis was also performed to evaluate the effects of tradipitant under \"calm\" and \"rough\" seas. Under \"calm\" sea conditions, only a small percentage of participants in either arm experienced vomiting, 26.7% versus 18.2% for placebo and tradipitant respectively (not significant). A similar MSSS Worst score was seen between the two groups, 3.32 and 3.40, for placebo and tradipitant respectively (not significant). \nUnder \"rough\" sea conditions, 72.2% of the placebo treated patients vomited as compared to 15.8% of those treated with tradipitant, p value = 0.0009. A significant effect was also seen under \"rough\" conditions in the MSSS Worst score, 4.57 and 3.19 for placebo and tradipitant respectively, p value = 0.0235 (Table 1). \nVanda intends to initiate a Phase III program in Motion Sickness, with a plan to file for marketing authorization in 2020.\nTable 1: Results of Motion Sifnos study for the Overall population and for the Calm and Rough Sea sub-populations.\n* ITT = Intent To Treat\nMotion Sickness\nMotion Sickness is a disorder that arises often as a response to real or perceived movement, as occurring during vehicular travel. Vomiting is the most disturbing symptom of motion sickness, although the disorder is often accompanied by a constellation of sym...

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