Vanda comes up short in lawsuit with FDA over tradipitant

Vanda Pharmaceuticals (NASDAQ:VNDA) is “determining the appropriate next steps” after the U.S. District Court for the District of Columbia ruled in favor of the FDA in a lawsuit brought by the company prompted by a dispute over the development of tradipitant (VLY-686) for the treatment of gastroparesis.

The disagreement arose over the proposed treatment duration. In April 2018, the company submitted a protocol for a 52-week open-label extension (OLE) study for patients who had completed a Phase 2 clinical trial (four weeks of therapy). A month later, based on agency feedback, it amended the protocol of the Phase 2 to a three-month treatment duration while it continued talks over a 52-week duration. In September 2018, it submitted a protocol for a new 52-week OLE study.

In December 2018, the FDA instituted a partial clinical hold (suspends enrollment but allows currently enrolled patients to continue treatment) on the two proposed studies, adding that toxicity testing in dogs, monkeys or pigs had to be done before it would consider signing off on treatment beyond 12 weeks. The company filed suit in February 2019 (10-K, page 51).

A Phase 3 trial assessing a 12-week treatment duration is in process.

https://seekingalpha.com/news/3537088-vanda-comes-up-short-in-lawsuit-fda-over-tradipitant