FDA Approves Fanapt for Bipolar 1

The FDA has approved Vanda Pharmaceuticals’ Fanapt (iloperidone) tablets to treat adults with acute manic or mixed episodes associated with bipolar I disorder. An estimated 2.8% of U.S. adults had bipolar disorder in the past year, according to the National Institute of Mental Health. Bipolar 1 is the more severe illness with episodes of alternative manic and depressive states that can last for weeks.

Stahl, M.D., Ph.D.

“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, M.D., Ph.D., professor of Psychiatry at the University of California San Diego, said in a news release.

Fanapt is an atypical antipsychotic agent that has been used for the acute treatment of patients with schizophrenia since its FDA approval in 2009. For the full year 2023, Fanapt generated sales of $90.9 million, a decrease of 4% from 2022. The price for a supply of eight tablets is $261 according to Drugs.com. The company offers a $0 copay per month for those with commercial insurance.

The approval of Fanapt for use bipolar was based on a pivotal study in 414 patients who were randomized to received either Fanapt or placebo. The primary endpoint was assessed by the Young Mania Rating Scale (YMRS), a rating scale of clinical severity in the core symptoms of mania, at week four.

Patients treated with Fanapt treated patients showed a larger improvement than placebo-treated patients. Adverse events included tachycardia, dizziness, dry mouth, increased alanine aminotransferase, nasal congestion, increased weight, and somnolence.

The results were published in The Journal of Clinical Psychiatry in January 2024.

Fanapt has a boxed warning about the risk of elderly patients with dementia-related psychosis treated with antipsychotic drugs may be at an increased risk of death. Fanapt is not approved for use in patients with dementia-related psychosis. In these patients, there is a higher incidence of cerebrovascular adverse events, including death, compared with placebo-treated patients.

Additionally, Fanapt is associated with prolonged QT interval, which indicates an inregular heart rhythm. The label for Fanapt indicates that physicians consider using other psychotics first.