Vanda Pharmaceuticals reports results from the phase III study of tradipitant in gastroparesis.

The study did not meet its prespecified primary endpoint which was the difference between drug and placebo on the change of the severity of nausea from baseline at week 12 of treatment. Both treatment arms showed significant improvements from baseline on nausea as well as the other core symptoms of gastroparesis. Initial exploratory analysis has identified potential confounders that may have masked the beneficial effect of the drug previously observed in the Phase II study of tradipitant, which include a baseline imbalance of rescue medication use between the two treatment arms as well as an observed poor compliance with study drug for some patients in the study. When restricting the analysis in the group of patients that used no rescue medications at baseline and adjusting for poor compliance, Vanda identified strong evidence of a drug effect across a number of symptoms and across the duration of the study, including a significant and meaningful effect at the prespecified primary endpoint of nausea change at week 12.

The Phase III study also continued to demonstrate that tradipitant is safe and well-tolerated, as seen in previous studies over the 12 weeks of treatment. Patients on tradipitant experienced a similar number of treatment emergent adverse events as patients receiving placebo. The most common adverse event where tradipitant frequency was higher than placebo was diarrhea. Patients that participated in the clinical program also had the opportunity to seek expanded access to tradipitant based on the benefit in the study and their individual unmet medical needs. Ten patients have received more than 3 months of tradipitant treatment, 6 of whom have received at least 1 year of tradipitant treatment.

"While disappointed that the study did not meet its prespecified outcome, we are encouraged by the evidence that is emerging from further analysis that confirms observations made in the prior clinical study," said Mihael H. Polymeropoulos , M.D., Vanda's President, CEO and Chairman of the Board."We are committed to completing our analysis and working to bring tradipitant to patients with gastroparesis to fill a significant unmet medical need." Vanda plans to continue the analysis of thebdata of this study and prepare the results for submission to peer review journals as well as prepare the data for submission to regulatory authorities.