Novel Drug Tradipitant Effective, Safe for Treatment of Nausea in Gastroparesis

Tradipitant appears to be an effective and safe treatment option for gastroparesis symptoms, according to research presented at the American College of Gastroenterology (ACG) 2021 Annual Meeting, held from October 22 to 27, 2021, in Las Vegas, Nevada and virtually.

The present analysis used data from the open-label extension (OLE) phase of a 4-week, phase 2 trial of tradipitant for the treatment of moderate to severe nausea in idiopathic or diabetic gastroparesis. Patients who completed the 4-week placebo-controlled phase were invited to enter the OLE phase, in which they received 85 mg tradipitant, twice daily, for an additional 8 weeks. Clinical symptoms were captured with the Gastroparesis Core Symptom Daily Diary and the Gastroparesis Cardinal Symptom Index questionnaire. Symptom improvements from baseline were calculated throughout the OLE phase.

The combined mean change in average daily nausea from baseline to week 8 of the OLE phase was -1.74 points (SD, 1.26; P <.0001). The mean change was comparable between patients who received tradipitant in the randomized phase and patients who received placebo (-1.78 [SD, 1.12] vs -1.71 [SD, 1.39], respectively).

Mean change in weekly proportion of nausea-free days from baseline to week 8 was 43.8% (SD, 39.3%; P <.0001). This change was numerically higher in patients who initially received tradipitant vs placebo (48.1% [SD, 36.6%] vs 40.2% [SD, 41.6%], respectively).

The efficacy and safety of tradipitant established during the 4-week randomization phase were maintained in the OLE phase. The drug was well-tolerated by patients and may present new means of symptom management for gastroparesis.   

Disclosure: All study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures. 

Reference

Carlin J, Fisher M, Bagger M, et al. Tradipitant, a novel neurokinin-1 receptor antagonist, showed continued improvement in nausea and other symptoms associated with gastroparesis in an open-label extension of a phase II clinical trial. Presented at: ACG 2021 Annual Meeting; October 22-27, 2021; Las Vegas, NV and virtual. Abstract P2032.