Health
Iloperidone (Fanapt) for Bipolar 1 Disorder Treatment Gets FDA Okay
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The U.S. Food and Drug Administration (FDA) has approved iloperidone (Fanapt) for the acute treatment of manic or mixed episodes associated with bipolar 1 disorder in adults. Initially approved by the FDA in 2009 for the treatment of schizophrenia, iloperidone is an atypical second-generation antipsychotic.
The most recent approval came after a phase 3 randomized, double-blind, placebo-controlled trial published in the Journal of Clinical Psychiatry in January 2024, which showed that people with bipolar mania who were treated with iloperidone saw significantly better results than those receiving a placebo. Improvements in symptoms were seen as early as two weeks after participants started the medication.
The study involved 414 participants randomized 1:1 to iloperidone or placebo for four weeks.
Mania is a defining feature of bipolar 1 disorder. Mixed episodes, in which depression and mania occur simultaneously or in quick succession, are more common in bipolar 1 disorder, and are associated with a more severe illness and increased suicide risk.
“Many patients today are still unable to find suitable treatment options for effectively managing bipolar disorder. Tailoring the right treatment for the right patient is critical for effective care, and the approval of Fanapt represents an important milestone,” Stephen Stahl, MD, PhD, a professor of psychiatry at the University of California in San Diego, said in a press release.
“Fanapt possesses a well-studied safety profile, and its approval will provide patients with a new and effective option for treating a highly complex disorder,” added Dr. Stahl.
A black box warning states that iloperidone is not approved for people with dementia-related psychosis and may increase the risk of death.
The most common side effects of iloperidone for bipolar mania include racing heart rate, dizziness, dry mouth, nasal congestion, drowsiness, weight gain, faintness or lightheadedness after standing suddenly, and elevated liver enzymes.
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