Vanda : Phase III Study Of Tradipitant In Gastroparesis Fails To Meet Prespecified Primary Endpoint

(RTTNews) - Vanda Pharmaceuticals Inc. (VNDA) said Friday that phase III Study of Tradipitant in Gastroparesis 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.

The Phase III clinical study, VP-VLY-686-3303, evaluated the efficacy and safety of tradipitant in treating the symptoms of gastroparesis.

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.

Vanda said it plans to continue the analysis of the data of the study and prepare the results for submission to peer review journals as well as prepare the data for submission to regulatory authorities.

In Friday pre-market trade, VNDA was trading at $12.50, down $2.15 or 14.68%.