FDA Rejects Vanda Pharma's Application for Gastroparesis Drug Tradipitant

By Colin Kellaher

The Food and Drug Administration has turned away a proposed drug from Vanda Pharmaceuticals to treat the stomach disorder gastroparesis.

Vanda on Thursday said the FDA has issued a so-called complete response letter for the drug, tradipitant, indicating the agency won't approve the application in its current form, and called for additional studies.

The Washington biopharmaceutical company said it believes the FDA "generally disregarded" evidence from two placebo-controlled trials, and that the additional studies the agency suggested include "a design and duration inconsistent with the advice of key experts in the field and not appropriate based on the scientific understanding and natural course of the disorder."

Vanda said it will continue to pursue approval of tradipitant in gastroparesis, a condition that affects the stomach muscles and prevents proper stomach emptying, and that it plans to file a separate application later this year seeking a green light for the drug for the prevention of vomiting in motion sickness.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

September 19, 2024 07:47 ET (11:47 GMT)

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