FDA Approves Extended-Release Aripiprazole Injected Monthly to Prevent Manic and Mixed Episodes in Bipolar I
In 2017 the US Food and Drug Administration approved a monthly injectable form of the atypical antipsychotic drug aripiprazole, Abilify Maintena, for the prevention of manic and mixed episodes in bipolar I disorder. The intramuscular injections are available for monotherapy in preparations of 300 mg or 400 mg. Maintena did not prevent depressive episodes.
Maintena is already FDA-approved for the treatment of schizophrenia and Tourette’s syndrome in adults.
The approval for bipolar I disorder follows a 52-week phase 3, double-blind, placebo-controlled randomized trial. Participants were experiencing a manic episode during screening for the study, met the criteria for bipolar I disorder, and had had at least one prior manic or mixed episode severe enough to require treatment.
Compared to placebo, Maintena in once-a-month injections delayed the recurrence of any mood episode following the initial manic episode at screening. When the researchers separated their analysis based on type of episode, Maintena reduced manic and mixed episodes compared to placebo, but did not do a better job than placebo at preventing depressive episodes.
An oral antipsychotic must be administered for 14 days following the first injection of Maintena. The extended-release injection is available as 300 mg– or 400 mg–strength powder that may be reconstituted, or as prefilled syringes.
Editor’s Note: Because Maintena is delivered as a once-a-month injection, it may be helpful for patients who struggle to take daily oral medications.
Saphris Reformulated for Kids with Bipolar I
The atypical antipsychotic asenapine has been reformulated for bipolar I disorder in children aged 10–17. The drug (trade name Saphris) was approved by the Food and Drug Administration (FDA) in 2009 for adults with schizophrenia and bipolar disorder. It is sometimes used as a treatment for mixed episodes (depression with some symptoms of mania).
The new formulation consists of 2.5mg tablets that are taken sublingually (under the tongue), and are available in a black cherry flavor. These can be prescribed as monotherapy for the acute treatment of manic or mixed episodes in children and teens.
