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
January 25, 2024 at 01:09 pm EST
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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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Vanda Pharmaceuticals Inc. is a biopharmaceutical company, which is focused on the development and commercialization of therapies to address high unmet medical needs and improve the lives of patients. The Companyâs commercial portfolio is comprised of three products: HETLIOZ for the treatment of non-24-hour sleep-wake disorder (Non-24) and for the treatment of nighttime sleep disturbances in smith-magenis syndrome (SMS), Fanapt (iloperidone) for the treatment of bipolar I disorder and a long acting injectable (LAI) formulation for the treatment of schizophrenia, and PONVORY (ponesimod) for the treatment of inflammatory/autoimmune disorders, including ulcerative colitis, psoriasis, Crohn's disease, atopic dermatitis, eosinophilic esophagitis and alopecia areata. The Company also has a range of drugs in development, including Tradipitant (VLY-686), VHX-896, VSJ-110, VPO-227, VTR-297, VQW-765, VCA-894A and Type 2S (CMT2S).
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