The Food and Drug Administration has approved a monthly injectable formulation of aripiprazole, (Abilify Maintena) , for a maintenance monotherapy treatment of bipolar I disorder for adults, Otsuka and Lundbeck have announced .

Patients treated with the injectable formulation of the atypical antipsychotic must continue to take a daily oral antipsychotic for the first 14 days. After that, however, the long-acting injectable (LAI) – which must be administered by a health care professional – can replace the daily medication.

The approval is based on phase 3 study data showing that the formulation was effective and safe. The 52-week, double-blind, placebo-controlled, randomized withdrawal trial compared continued use of aripiprazole with placebo in adults aged 18-65 years with bipolar I and a history of at least one manic or mixed episode requiring hospitalization, treatment with a mood stabilizer, and/or treatment with an antipsychotic agent. Aripiprazole delayed the time to recurrence of manic and mixed episodes, though not depressive episodes, compared with placebo.

Joseph R. Calabrese, MD , director of the mood disorders program at University Hospitals Cleveland Medical Center, said in the July 28 announcement that the LAI is a new treatment option for bipolar I patients “who have established tolerability with oral aripiprazole.”

The drug label includes a warning that elderly patients with dementia-related psychosis who are treated with antipsychotics are at a higher mortality risk. Adverse reactions that have been associated with treatment with aripiprazole include weight gain, akathisia, injection site pain, sedation, and certain compulsive behaviors.

Created by Otsuka, and marketed by Otsuka and Lundbeck, the LAI was approved in the United States for treating adults with schizophrenia in 2013.

dwatson@frontlinemedcom.com

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