Gastroparesis is a serious medical condition characterized by delayed gastric emptying, leading to severe symptoms such as
nausea,
vomiting, and difficulty finishing meals. This condition significantly impacts the daily lives of affected patients.
Vanda Pharmaceuticals has been working on a drug called tradipitant to alleviate these symptoms, but recent developments have thrown a wrench into their plans.
The United States Food and Drug Administration (FDA) has rejected the new drug application (NDA) submitted by Vanda Pharmaceuticals for
tradipitant as a treatment for gastroparesis symptoms. The rejection was conveyed through a complete response letter (CRL), which essentially dismisses the submitted evidence and suggests that further studies are needed. Vanda Pharmaceuticals believes that the FDA's suggested study designs and durations are inconsistent with the advice of experts and the existing scientific understanding of gastroparesis.
In December 2023, the FDA accepted the NDA for tradipitant, which was supported by evidence from two placebo-controlled studies, exposure response data from a large open-label study, and real-world experiences from patients in an expanded access program. Despite this robust backing, the FDA's CRL has called for additional studies, putting a significant hurdle in the drug's path to approval.
In a media release, Vanda Pharmaceuticals expressed their frustration, noting that the FDA's action was delayed by over 185 days, which they argue violates the Food Drug and Cosmetic Act (FDCA). According to the FDCA, the FDA is required to review a new drug application and within 180 days provide either an approval or an opportunity for a hearing. In this case, Vanda contends that the FDA has failed to fulfill either of these requirements.
Vanda Pharmaceuticals also highlighted that the tradipitant NDA meets the standard for evidence of efficacy and has a favorable benefit-risk profile for gastroparesis patients. Despite multiple requests from Vanda, the FDA declined to convene an expert advisory committee to review the application. In response to the FDA's decision, patients currently being treated with tradipitant have filed a citizen petition urging the agency to approve the treatment.
Despite this regulatory setback, Vanda Pharmaceuticals remains committed to pursuing marketing authorization for tradipitant. The company plans to continue supporting the ongoing expanded access program, which serves several dozen patients suffering from gastroparesis. Additionally, Vanda is not backing down on its overall strategy for tradipitant; the company plans to submit a separate NDA for the drug aimed at preventing vomiting due to
motion sickness by the end of 2024.
While the rejection is a significant obstacle, Vanda Pharmaceuticals is determined to overcome it and bring tradipitant to market, driven by the needs of patients suffering from gastroparesis. This ongoing struggle underscores the complexities and challenges inherent in bringing new treatments to market, especially for conditions as debilitating as gastroparesis.
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