Extended-Release Abilify Approved for Bipolar Disorder

Ostuka Pharmaceutical Co and H Lundbeck A/S recently announced the approval of aripiprazole (Abilify Maintena) extended-release injectable suspension for the treatment of bipolar 1 disorder (BP-1), according to a press release. Aripiprazole received approval as a maintenance monotherapy for BP-1.

Aripiprazole is a monthly injection that is administered intramuscularly. It was created by Otsuka and co-developed and co-commercialized with Lundbeck, according to the release.

The approval is the result of positive findings from a phase 3 clinical trial that showed aripiprazole delayed mood episodes in adults with BP-1 compared with placebo.

Included in the study were patients who experienced a manic episode at baseline and had BP-1. All patients included had at least 1 previous manic or mixed episode with manic symptoms that required hospitalization, treatment with a mood stabilizer, and/or treatment with an antipsychotic.

The authors noted a substantial delay in the onset of mood episodes during the 52-week study. Additionally, the investigators found significant differences between treatment groups in time to recurrence of manic and mixed episodes; however, there was no significant difference in depressive mood episodes, according to the release.

Otsuka warns that elderly patients with dementia-related psychosis taking an antipsychotic may be at an increased risk of death. For this reason, aripiprazole is not approved to treat patients with this condition.

Aripiprazole was first approved in 2013 to treat schizophrenia. Common adverse events for these patients include weight gain, akathisia, injection site pain, and sedation, according to the release.

“Bipolar I disorder is a recurrent chronic mental illness. Abilify Maintena provides healthcare professionals (HCPs) a new treatment option for their patients who have established tolerability with oral aripiprazole,” said Joseph Calabrese, MD, director of the Mood Disorders Program at University Hospitals Cleveland Medical Center, and professor of psychiatry at Case Western Reserve University School of Medicine. “Receiving Abilify Maintena each month as prescribed and administered by a HCP, provides patients an opportunity to be free from taking their daily antipsychotic for bipolar I disorder; it is important to note that concomitant oral antipsychotic must be administered for 14 days after the first injection.”