Drug maker sues FDA over a dog study — and its stock goes into a tailspin

Is Vanda Pharmaceuticals (VNDA) barking up the wrong tree?

The drug maker filed a lawsuit against the Food and Drug Administration for placing a partial clinical hold on a stomach medicine it’s testing and requiring a nine-month study in dogs in order to provide dosing in humans for more than 12 weeks.

The move caps a yearlong dispute with the agency over the need for such testing. The company hopes to win approval to use the medicine, called tradipitant, to treat gastroparesis, although toxicology data from a nine-month study in dogs would presumably provide greater insight into the extent to which further testing in humans would pose any risks.

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