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
- 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
- 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. Gastroenterology, 160(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
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SOURCE Vanda Pharmaceuticals Inc.