Vanda Pharmaceuticals announces the publication of Efficacy and Safety of Iloperidone in Bipolar Mania: A Double-Blind, Placebo-Controlled Study in the Journal of Clinical Psychiatry
Wednesday, January 17, 2024 1 min read
Key Takeaway: Vanda Pharmaceuticals has published a pivotal study on the efficacy and safety of Iloperidone for treating bipolar mania in the Journal of Clinical Psychiatry. The findings are part of a supplemental New Drug Application for Fanapt® recently submitted to the FDA. The regulatory body has set an action date of April 2, 2024, for the review of this application, which highlights the potential significance of Iloperidone in addressing bipolar I disorder in adults.
Market Sentiment Analysis
POSITIVE FACTORS
Publication in a reputable journal validates the study's findings.
The study supports the use of Iloperidone for treating bipolar I disorder.
FDA's interest indicated by the set action date for the application.
Full Press Release Details
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.
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.
For full U.S. Prescribing Information for Fanapt®, including indication, Boxed Warnings and Important Safety Information, visit our Web site at www.fanapt.com.
Senior Vice President, Chief Financial Officer and Treasurer
Vanda Pharmaceuticals Inc.
SOURCE Vanda Pharmaceuticals Inc.
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Frequently Asked Questions
What study did Vanda Pharmaceuticals publish?
Vanda published a study on iloperidone's efficacy and safety in bipolar mania.
Where was the iloperidone study published?
The study was published in the Journal of Clinical Psychiatry.
What is Vanda's FDA application about?
It concerns the use of Fanapt® for treating bipolar I disorder in adults.
When is the FDA's action date for Vanda's application?
The FDA's target action date is April 2, 2024.
Who were the authors of the iloperidone study?
The study was authored by Torres R, Czeisler EL, Chadwick SR, et al.