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FDA Approves Iloperidone for Bipolar I Disorder

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FDA,Iloperidone,Bipolar I Disorder

The FDA has approved iloperidone for the treatment of bipolar I disorder based on positive results from a phase 3 trial. Patients treated with iloperidone showed significant improvement in symptoms compared to those who received a placebo.

The latest approval was based on results of a phase 3 randomized, double-blind, placebo-controlled trial showing that patients with treated with iloperidone had significantly better outcomes vs those who received placebo, with symptom improvement as early as 14 days after the initial dose. "Manic or mixed episodes associated with bipolar I disorder are highly complex conditions, which require a host of trusted options to meet individual patient needs.

With over 100,000 patient years of experience, Fanapt is a familiar therapeutic agent that offers flexible dosing with a well-known safety profile. This FDA approval gives patients and service providers a new treatment option for managing bipolar I disorder," Mihael H. Polymeropoulos, MD, president, CEO, and chair of the board of the drug manufacturer Vanda Pharmaceuticals, said in a press releas

 

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