Court Rules in Favor of FDA Over Partial Clinical Hold of Vanda’s Tradipitant Study

A U.S. court ruled in favor of the FDA in a case filed by Vanda Pharmaceuticals alleging the agency didn’t provide an adequate scientific reason for a partial clinical hold issued for the company’s long-term study of tradipitant for treatment of gastroparesis.

Vanda’s suit questions the FDA’s regulatory authority for placing the hold while requiring the company to conduct nine-month nonrodent toxicity studies, claiming FDA guidances do not have the force of law.

The agency responded that “existing tradipitant studies in nonrodents contain sufficient troubling indications of toxicity such that — while shorter-term human studies may be safe enough to proceed — FDA needs to see if those toxicity markers increase during long-term nonrodent studies before allowing long-term human studies.” The U.S. District Court in the District of Columbia agreed.

Currently, a 12-week phase 3 trial is in progress while Vanda determines the appropriate next steps in response to the ruling.