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Vanda Pharmaceuticals announces the publication of an article on "The Efficacy of Tradipitant in Patients with Diabetic and Idiopathic Gastroparesis in Phase III Randomized Placebo-Controlled Clinical Trial" in the Clinical Gastroenterology and Hepatology Journal

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Vanda Pharmaceuticals Inc. (VNDA) announced the publication of a pivotal phase III study on the efficacy of tradipitant in treating gastroparesis in adults. The study, published in the Clinical Gastroenterology and Hepatology Journal, follows a previous study in 2021. The FDA has set a decision date for September 18, 2024, for the New Drug Application for tradipitant.
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The recent publication in the Clinical Gastroenterology and Hepatology Journal regarding Vanda Pharmaceuticals' phase III study of tradipitant signifies a critical milestone for the company and the medical community. This study's positive outcome, which is crucial for the FDA's review process, could potentially lead to the approval of a new treatment for gastroparesis, a condition characterized by delayed gastric emptying in the absence of an obstructive lesion. Gastroparesis can cause severe symptoms such as nausea, vomiting and abdominal pain and can significantly impair quality of life. Currently, treatment options are limited and the approval of tradipitant would fill a significant unmet medical need.

From a research perspective, the efficacy demonstrated by tradipitant in a rigorous phase III trial provides strong evidence to support its therapeutic potential. The study's design, a randomized placebo-controlled trial, is the gold standard for determining drug efficacy, thus enhancing the credibility of the results. If the FDA approves tradipitant based on this data, it could lead to increased research interest in similar neurokinin-1 (NK1) receptor antagonists, potentially ushering in a new class of treatments for gastrointestinal disorders.

For investors and stakeholders in Vanda Pharmaceuticals, the announcement is a significant development that could impact the company's financial trajectory. The setting of a Prescription Drug User Fee Act (PDUFA) target action date by the FDA provides a clear timeline for potential market entry. Approval of tradipitant would not only diversify Vanda's product portfolio but also open up a new revenue stream. Given the chronic nature of gastroparesis and the lack of effective treatments, there is a substantial market opportunity for tradipitant.

It is essential for investors to consider the potential market size and the competitive landscape. If tradipitant is approved, Vanda would be well-positioned to capture a significant share of the gastroparesis treatment market. However, investors should also be aware of the risks, such as potential regulatory hurdles, challenges in commercialization and the possibility of adverse events emerging in the long term. Additionally, the impact of insurance coverage and pricing strategies on market penetration will be critical factors to monitor post-approval.

From a market perspective, the successful publication of phase III trial results for tradipitant and the subsequent FDA submission is a promising development for those tracking advancements in gastrointestinal treatments. Gastroparesis affects a significant patient population, with diabetic gastroparesis being particularly prevalent due to the rising incidence of diabetes globally. An approved treatment could therefore address a growing market need.

Understanding patient demographics, current treatment satisfaction levels and the accessibility of existing therapies will be crucial in assessing tradipitant's potential market impact. The drug's success will depend on its efficacy relative to current standards of care, its safety profile and its ability to improve patient outcomes. Market acceptance will also hinge on physician awareness and the drug's inclusion in treatment guidelines, which can influence prescribing behavior. The anticipation of the FDA's decision will likely keep industry stakeholders and potential competitors vigilant, as they prepare for the implications of a new entrant in the gastroparesis therapeutics space.

WASHINGTON, Jan. 25, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced the publication of an article titled "The Efficacy of Tradipitant in Patients with Diabetic and Idiopathic Gastroparesis in Phase III Randomized Placebo-Controlled Clinical Trial" in the Clinical Gastroenterology and Hepatology Journal1 which follows a previously published study of tradipitant in the treatment of gastroparesis in 2021.2 The findings of this pivotal phase III study are included in the New Drug Application for tradipitant in the treatment of gastroparesis in adults submitted to the U.S. Food and Drug Administration (FDA) The FDA has set a Prescription Drug User Fee Act target action date of September 18, 2024 for its decision.

References

  1. Carlin, J. L., Polymeropoulos, C., Camilleri, M., Lembo, A., Fisher, M., Kupersmith, C., Madonick, D., Moszczynski, P., Smieszek, S., Xiao, C., Birznieks, G., & Polymeropoulos, M. H. (2024). The efficacy of tradipitant in patients with diabetic and idiopathic gastroparesis in phase III randomized placebo-controlled clinical trial. Clinical Gastroenterology and Hepatology. Available online: https://www.cghjournal.org/article/S1542-3565(24)00050-8/fulltext 
  2. Carlin, J. L., Lieberman, V. R., Dahal, A., Keefe, M. S., Xiao, C., Birznieks, G., Abell, T. L., Lembo, A., Parkman, H. P., & Polymeropoulos, M. H. (2021). Efficacy and Safety of Tradipitant in Patients With Diabetic and Idiopathic Gastroparesis in a Randomized, Placebo-Controlled Trial. Gastroenterology160(1), 76–87.e4. Available online: https://doi.org/10.1053/j.gastro.2020.07.029

About Vanda Pharmaceuticals Inc.

Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit www.vandapharma.com and follow us on X @vandapharma.

About Tradipitant

Tradipitant is an NK-1R antagonist licensed by Vanda from Eli Lilly and Company. Tradipitant is currently in clinical development for gastroparesis and motion sickness. The FDA has imposed a partial clinical hold on tradipitant clinical protocols of longer than 12 weeks duration.

Corporate Contact:
Kevin Moran
Senior Vice President, Chief Financial Officer and Treasurer
Vanda Pharmaceuticals Inc.
202-734-3400
pr@vandapharma.com

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/vanda-pharmaceuticals-announces-the-publication-of-an-article-on-the-efficacy-of-tradipitant-in-patients-with-diabetic-and-idiopathic-gastroparesis-in-phase-iii-randomized-placebo-controlled-clinical-trial-in-the-clinical-gastro-302045026.html

SOURCE Vanda Pharmaceuticals Inc.

FAQ

What did Vanda Pharmaceuticals announce?

Vanda Pharmaceuticals announced the publication of a pivotal phase III study on the efficacy of tradipitant in treating gastroparesis in adults.

Where was the study published?

The study was published in the Clinical Gastroenterology and Hepatology Journal.

When is the FDA decision date for the New Drug Application for tradipitant?

The FDA has set a decision date for September 18, 2024, for the New Drug Application for tradipitant.

What was the previous study about?

The previous study was about the efficacy and safety of tradipitant in patients with diabetic and idiopathic gastroparesis in a randomized, placebo-controlled trial.

Vanda Pharmaceuticals Inc.

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vanda is a specialty pharmaceutical company focused on the development and commercialization of novel therapies to address high unmet medical needs and improve the lives of patients.