FDA approves Fanapt for bipolar disorder in adults

The FDA has approved Fanapt tablets for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.

Vanda Pharmaceuticals Inc. stated in a press release that Fanapt (iloperidone) is an atypical antipsychotic agent prescribed for acute treatment of individuals with schizophrenia since its FDA approval in 2009.

"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,” Mihael H. Polymeropoulos, MD, Vanda's president, CEO and chairman of the board, stated in the release. “This FDA approval gives patients and service providers a new treatment option for managing bipolar I disorder.”

Approval of Fanapt was based on results of a multicenter, phase 3 study in which approximately 400 individuals with a history of bipolar I disorder and suffering from a current bout of mania were randomized 1:1 to receive either Fanapt or placebo for 4 weeks. The primary endpoint was change from baseline to week 4 in the Young Mania Rating Scale (YMRS), which assessed clinical severity in the core symptoms of mania at weeks 1, 2, 3 and 4. Greater improvement in the Fanapt treated group was observed compared with those given placebo at week 2. By week 4, those treated with Fanapt demonstrated a significantly larger improvement compared with those given placebo.

Additionally, per the release, the safety profile of Fanapt in this study was similar to that seen in previous studies featuring Fanapt to treat schizophrenia in adults.

Reference:

• Fanapt shown to be effective in bipolar I disorder in phase III clinical study. https://vandapharmaceuticalsinc.gcs-web.com/node/15146/pdf. Published Dec. 19, 2022. Accessed April 3, 2024.