Vanda Pharmaceuticals Inc (NASDAQ:VNDA) shares are plunging after the company announced Phase 3 trial data of tradipitant in treating the symptoms of gastroparesis.
Gastroparesis is a condition that reduces the ability of the stomach to empty its contents. It does not involve a blockage (obstruction).
The study did not meet its prespecified primary endpoint, the difference between drug and placebo on the severity of nausea from baseline at week 12 of treatment.
Both treatment arms showed significant improvements from baseline on nausea and 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 2 study of tradipitant, including a baseline imbalance of rescue medication use between the two treatment arms.
Also, the company says that it observed poor compliance with study drug for some patients in the study.
When restricting the analysis to patients who did not use rescue medications and adjusting for poor compliance, Vanda identified drug effects, including a significant effect at the prespecified primary endpoint of nausea change at week 12.
The Phase 3 study also demonstrated that tradipitant is safe and well-tolerated.
Patients on tradipitant experienced similar treatment-emergent adverse events as patients receiving placebo.
The most common adverse event where tradipitant frequency was higher than placebo was diarrhea.
VNDA shares are down $3.19, or 21.8% at $11.46 early Friday.
