WASHINGTON, Jan. 17, 2024 /PRNewswire/ — Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced the publication of an article titled “Efficacy and Safety of Iloperidone in Bipolar Mania: A Double-Blind, Placebo-Controlled Study” in the Journal of Clinical Psychiatry.1 The findings of this pivotal study have been submitted to the U.S. Food and Drug Administration (FDA) as part of Vanda’s supplemental New Drug Application for Fanapt® in the treatment of bipolar I disorder in adults. The FDA has set a Prescription Drug User Fee Act target action date of April 2, 2024 for its decision.
References
Torres R, Czeisler EL, Chadwick SR, et al. Efficacy and safety of iloperidone in bipolar mania: a double-blind, placebo-controlled study. J Clin Psychiatry. 2024;85(1):23m14966. Available online: https://doi.org/10.4088/JCP.23m14966
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 Twitter @vandapharma.
About Fanapt®
For full U.S. Prescribing Information for Fanapt®, including indication, Boxed Warnings and Important Safety Information, visit our Web site at www.fanapt.com.
Corporate Contact:Kevin Moran
Senior Vice President, Chief Financial Officer and Treasurer
Vanda Pharmaceuticals Inc.
202-734-3400
[email protected]
SOURCE Vanda Pharmaceuticals Inc.
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