Tradipitant

Vanda announced that the FDA has accepted the filing of Vanda's New Drug Application (NDA) for tradipitant for the treatment of symptoms of gastroparesis. If approved, tradipitant will be the first novel drug to be approved by the FDA for the treatment of gastroparesis in over 40 years and to be accepted for review by the FDA for gastroparesis in over 30 years. Tradipitant is an NK-1R antagonist. It works by blocking substance P, a small signaling molecule. Tradipitant can affect gastric peristalsis and directly affect neurotransmission in the brain area responsible for nausea and vomiting, thus playing a role in the treatment of symptoms of gastroparesis. This NDA is mainly based on the results of the Phase II VP-VLY-686-2301 study and the Phase III VP-VLY-686-3301 study.