Hope for Those Suffering From Gastroparesis?

Gastroparesis is a chronic medical condition that can cause unpleasant and refractory symptoms that adversely affect quality of life. Unfortunately, metoclopramide, which can cause serious side effects, is the only medication that is approved by the U.S. Food and Drug Administration (FDA) for gastroparesis. This phase II, multicenter, randomized, placebo-controlled trial evaluated the efficacy and safety of tradipitant (a new antagonist of tachykinin receptor 1 [NK1R]) compared to placebo for reducing nausea and vomiting symptoms associated with idiopathic or diabetic gastroparesis. 

For the study, 152 patients (60% with idiopathic gastroparesis vs 40% with diabetic gastroparesis) at 47 different sites were randomly assigned to receive 85 mg of oral tradipitant (n=77) or placebo (n=75) twice daily for 4 weeks. Nausea was assessed using the 5-point Gastroparesis Core Symptom Daily Diary, and overall gastroparesis symptoms were evaluated using the Gastroparesis Cardinal Symptom Index and Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index. 

In patients who received tradipitant, there was a significant improvement in nausea (nausea score decrease of 1.25) compared with placebo (nausea score decrease of 0.73) (P=.0099), as well as a significant increase in nausea-free days (28.8% vs 15.0%; P=.0160). Patients with nausea and vomiting at baseline (n=101) had an even greater decrease in nausea with tradipitant (reduction of 1.4) compared to placebo (reduction of 0.4) (P<.0001). Additionally, the tradipitant group had a significant increase in nausea-free days at week 4 (32.3% vs 7.6% on placebo; P=.0003). A greater than 1-point improvement in the Gastroparesis Cardinal Symptom Index score was observed in 46.6% of patients on tradipitant compared with 23.5% of patients on placebo (P=.0053). No life-threatening adverse events were noted.