Tradipitant

FDA declines Vanda's tradipitant NDA for gastroparesis, citing need for additional studies despite evidence of efficacy. Vanda plans to pursue marketing authorization and submit an NDA for motion sickness prevention.

Evoke Pharma reaffirms commitment to improving diabetic gastroparesis treatment with Gimoti nasal spray after FDA's rejection of Vanda Pharmaceuticals' Tradipitant.

The FDA denied Vanda Pharmaceuticals’ application for tradipitant, an NK-1R antagonist for gastroparesis, citing a need for additional studies. Vanda criticized the FDA's decision, arguing the agency disregarded evidence and delayed the verdict. The company plans to continue seeking approval and is working on a separate application for tradipitant to prevent motion sickness-induced vomiting.

FDA declined Vanda Pharmaceuticals' NDA for tradipitant in gastroparesis treatment, citing need for additional studies. Vanda criticized the decision, noting delays and lack of FDA advisory committee review. Tradipitant showed efficacy in reducing nausea in clinical trials, with plans for further submissions and continued support for its expanded access program.

Vanda Pharmaceuticals Inc. announced the FDA declined approval for tradipitant to treat gastroparesis, citing insufficient evidence despite Vanda's submission of two placebo-controlled studies and real-world data. Vanda disputes the FDA's decision, plans to continue pursuing approval, and supports an expanded access program for patients. A separate NDA for tradipitant for motion sickness is planned.

FDA rejected Vanda Pharmaceuticals' tradipitant for gastroparesis, citing insufficient evidence. Vanda disputes the decision, arguing tradipitant's efficacy and safety, and plans to seek approval again while continuing its expanded access program.

Vanda Pharmaceuticals Inc. announced the FDA declined approval for tradipitant, aimed at treating gastroparesis symptoms, citing insufficient evidence. Despite supporting studies and patient advocacy, the FDA requested further research. Vanda plans to continue pursuing approval and supports an expanded access program for patients.

FDA issued a Complete Response Letter to Vanda Pharmaceuticals regarding the NDA for tradipitant for gastroparesis treatment, requesting additional studies. Despite statistically significant improvements in nausea and other symptoms observed in trials, the application could not be approved in its current form.