FDA accepts NDA for tradipitant for the treatment of gastroparesis

The FDA has set September 18, 2024 as the target date for its decision under the Prescription Drug User Fee Act (PDUFA).

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.

Gastroparesis is a serious medical condition characterized by delayed gastric emptying associated with the symptoms of nausea, vomiting, bloating, fullness after meals and abdominal pain, along with significant impairment of social and occupational functioning. The estimated prevalence of gastroparesis in the U.S. is approximately 6 million patients, many of whom remain undiagnosed.

In support of this application, the FDA accepted for review Vanda's non-animal preclinical toxicology data derived from microphysiological systems that was provided by Vanda in the absence of a nine-month toxicity dog study. Vanda believes that this is an important milestone in its multi-year effort to convince the FDA to move away from animal toxicology studies and instead adopt novel and advanced human-relevant technologies.

"We are very pleased with the FDA's acknowledgment of the completeness of our application and we look forward to a substantive review. Tradipitant, if approved, will be the first novel drug for patients with gastroparesis since 1979," said Mihael H. Polymeropoulos, M.D., Vanda's President, CEO and Chairman of the Board. "We are also encouraged by the FDA's decision to accept for filing this application that includes non-animal preclinical toxicity data from advanced human-relevant microphysiological systems in the absence of a nine-month dog study."

The NDA submission includes results from clinical efficacy studies 2301 and 3301, evidence from a large 12-week open label study and data from the Expanded Access program. The safety database in this application now under review includes over 1,000 patients with exposures of up to 12-weeks, as well as data from the Expanded Access program with patient exposures of over two years.

The FDA's action on this application will mark the third NDA or supplemental New Drug Application (sNDA) decision expected by Vanda in 2024; a sNDA for Hetlioz for the treatment of insomnia characterized by difficulties with sleep initiation has a PDUFA target action date of March 4, 2024 and a sNDA for Fanapt for the acute treatment of manic or mixed episodes associated with bipolar I disorder has a PDUFA target action date of April 2, 2024.