Thursday, the FDA declined to approve Vanda Pharmaceuticals Inc.’s  New Drug Application (NDA) of tradipitant for symptoms in gastroparesis, providing Vanda with a Complete Response Letter (CRL).

Gastroparesis (means paralysis of the stomach) is a condition that slows down the stomach’s ability to empty its contents.

It is associated with severe nausea, vomiting, and difficulty finishing a normal meal.

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The FDA has approved no effective treatment in over 40 years.

Vanda’s tradipitant application included evidence from two placebo-controlled studies, the results of which were published in peer-reviewed journals.

The CRL was conclusory in nature. It generally disregarded the evidence provided and instead suggested that Vanda conduct additional studies with a design and duration inconsistent with the advice of key experts in the field and not appropriate based on the scientific understanding and natural course of the disorder. 

Furthermore, the FDA’s action was delayed by more than 185 days and failed to satisfy the Food Drug and Cosmetic Act (FDCA) requirements.

The FDCA requires that the FDA review a new drug application and provide either an approval or an opportunity for a hearing within 180 days of submission. In this case, the FDA failed to do either.

Despite the FDA’s disappointing action, Vanda believes that the tradipitant application has met the substantial evidence of efficacy standard and has a favorable benefit-risk profile for gastroparesis patients. 

While Vanda has repeatedly requested that the FDA convene an expert advisory committee to review the application and advise the Commissioner on its approvability, the FDA has refused to do so.

The company added that several patients currently treated with tradipitant have filed a Citizen Petition urging the FDA to approve tradipitant for gastroparesis.

Vanda will continue to pursue the marketing authorization for tradipitant and support the expanded access program.

Vanda plans to submit a separate NDA for tradipitant to prevent vomiting in motion sickness later this year.

Price Action: VNDA stock is down 7.68% at $4.57 at the last check on Thursday.

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