Tradipitant Shows Promise in Alleviating Nausea in Gastroparesis

• Primary Outcome: The intention-to-treat (ITT) population did not show a significant difference in nausea severity change between the tradipitant and placebo groups at week 12 (P = .741).

• Exposure-Response Analysis: Post hoc analyses, considering factors such as drug exposure, rescue medications, and baseline severity inflation, revealed significant improvements in average nausea severity in subjects with high blood levels of tradipitant starting from weeks 2 through 4.

• Sensitivity Analyses: When accounting for confounding factors, tradipitant treatment demonstrated strengthened effects, with statistically significant improvements in nausea observed at week 12.

While tradipitant did not achieve significance in the ITT population, the study's exposure-response analysis indicated significant effects with adequate tradipitant exposure. Post hoc sensitivity analyses further supported the potential of tradipitant as a treatment for nausea in gastroparesis patients. These findings highlight the need for further research to explore tradipitant's efficacy in managing gastroparesis symptoms.

Reference:

Carlin, J. L., Polymeropoulos, C., Camilleri, M., Lembo, A., Fisher, M., Kupersmith, C., Madonick, D., Moszczynski, P., Smieszek, S., Xiao, C., Birznieks, G., & Polymeropoulos, M. H. The efficacy of tradipitant in patients with diabetic and idiopathic gastroparesis in phase III randomized placebo-controlled clinical trial. Clinical Gastroenterology and Hepatology: The Official Clinical Practice Journal of the American Gastroenterological Association,2024. https://doi.org/10.1016/j.cgh.2024.01.005