Bipolar 1 Disorder: FDA Approves Iloperidone

Iloperidone (Fanapt) has received FDA approval for the acute treatment of bipolar 1 disorder, according to a statement from Vanda Pharmaceuticals.

According to a statement made by Vanda Pharmaceuticals, iloperidone (Fanapt) has been approved by the FDA for the acute treatment of manic or mixed episodes associated with bipolar 1 disorder in adults.

Atypical antipsychotic medication of the second generation, iloperidone, is used to treat bipolar mania symptoms. The FDA approved iloperidone in 2009 for the treatment of schizophrenia in adults; however, the label cautions that iloperidone increases the risk of death in older patients with psychosis associated with dementia.

“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, professor of Psychiatry at the University of California San Diego, said in the statement.1 “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.”

Vanda released the phase 3 clinical trial results in January and included them with the supplemental new drug application for iloperidone used to treat adult bipolar 1 disorder. When compared to the placebo group, the findings showed a significant improvement in both primary and secondary endpoints for the patients who received iloperidone.

The Young Mania Rating Scale (YMRS) total score change from baseline to week 4 in comparison with placebo was the study’s main goal. Changes in the Clinical Global Impressions-Severity and Clinical Global Impression of Change ratings were examples of secondary efficacy objectives.

Adults with a diagnosis of bipolar mania participated in a randomized, double-blind, placebo-controlled trial that took place between April 2021 and September 2022 at 27 locations in the US and abroad. Over four weeks, participants were randomized to receive either a placebo or iloperidone at doses up to 24 mg/day administered twice daily.

By week four, iloperidone significantly outperformed placebo in terms of both primary and secondary end goals. A significant decrease in YMRS total scores was found by the study, with a difference in least-squares mean of -4.0 (95% CI, −5.70 to −2.25; P =.000008).

A total of 414 subjects were given a placebo (n = 208) or iloperidone (n = 206) at least once. With 18 patients receiving iloperidone and 11 patients receiving placebo dropping out owing to adverse events, 67.1% of iloperidone patients and 72.9% of placebo patients finished the trial.

Tachycardia, vertigo, dry mouth, elevated alanine aminotransferase, nasal congestion, weight gain, and somnolence were among the frequent side effects. The incidence of extrapyramidal symptom-related treatment-emergent adverse events and akathisia remained minimal, according to the study investigators.

There were no new safety concerns, and the safety profile seen in the trial was consistent with earlier clinical studies involving patients with schizophrenia.

“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,” Michael H. Polymeropoulos MD, President, CEO, Vanda said in the statement.1 “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.”

Source Link