S3122 Responder Analysis for the Efficacy of Tradipitant in Idiopathic and Diabetic Gastroparesis

Introduction: Tradipitant is a novel NK1R antagonist studied in diabetic and idiopathic gastroparesis. This report presents a nausea responder analysis from the open-label arm of a multicenter, randomized, double-blind, placebo-controlled study (VP-VLY-686-3301) assessing the efficacy of tradipitant in relieving symptoms of gastroparesis. Methods: Overall, 531 idiopathic and diabetic gastroparesis patients with delayed gastric emptying received open label 85 mg tradipitant twice per day for 12 weeks. Symptoms were assessed using the 5-point Gastroparesis Core Symptom Daily Diary (GCSDD). A nausea responder (n = 267) was defined as having ≤1 average nausea severity at week 12 using the GCSDD. Gastroparesis symptoms were assessed every 2 weeks in clinic using the Gastroparesis Cardinal Symptom Index. Results: Nausea responders improved average nausea score significantly from baseline after 12 weeks tradipitant (improvement of -1.40 vs 1.67 at baseline; P < 0.0001). A significant improvement was also seen in the percent of nausea free days (an addition of 49.32% of days for tradipitant vs 28.57% at baseline; P < 0.0001). Significant improvement was also seen in other cardinal gastroparesis symptoms including average times vomited in the past 24 hours (improvement of -0.32 vs 0.40 at baseline; P < 0.0001), stomach fullness (improvement of -1.48 vs 2.86 at baseline; P < 0.0001), not being able to finish a normal-sized meal (improvement of -1.45 vs 2.47 at baseline; P < 0.0001), bloating (improvement of -1.36 vs 2.70 at baseline; P < 0.0001), and upper abdominal pain (improvement of -1.25 vs 1.99 at baseline; P < 0.0001). Conclusion: Tradipitant demonstrated statistically significant improvement from baseline in average nausea severity in this 12-week open-label study in both idiopathic and diabetic gastroparesis subjects. Notably, nausea responders on tradipitant also significantly improved in all cardinal gastroparesis symptoms including those unrelated directly to nausea such as abdominal pain. These results suggest tradipitant has the potential for comprehensive gastroparesis symptom relief in tradipitant responders.