Vanda Pharmaceuticals, Inc. has reported encouraging Phase III results from Study 3601 evaluating NEREUS™ (tradipitant) for prevention of vomiting induced by GLP-1 receptor agonist therapy.
The study indicated a statistically significant decrease in any vomiting episodes, with 43.0% occurrence in the NEREUS™ group compared to 58.5% in the placebo group (p=0.006). Secondary endpoints, including severe nausea and vomiting, were also notably improved.
These positive outcomes support the potential of NEREUS™ as an effective preventative treatment for GLP-1–induced vomiting. Vanda Pharmaceuticals plans to engage with the FDA regarding these results and intends to submit a supplemental New Drug Application (sNDA).