This article is more than 5 years old. Information may no longer be current.

FDA approves new injection site for Abilify Maintena to treat schizophrenia

Otsuka Pharmaceutical, Inc. and Lundbeck recently announced the FDA expanded the label of Abilify Maintena for extended-release injectable suspension for schizophrenia to include the deltoid arm muscle.

Health care providers now have the option to inject Abilify Maintena (aripiprazole, Otsuka America Pharmaceutical, Inc.) in the gluteal or deltoid muscle when treating patients with schizophrenia.

Safety and tolerability of aripiprazole administered in the deltoid muscle was evaluated in two open-label studies composed of stable patients aged 18 to 64 years currently diagnosed with schizophrenia.

In the first study — a randomized, single-dose, parallel-arm, relative bioavailability study — researchers assessed the pharmacokinetic parameters of aripiprazole.  They administered 400 mg of aripiprazole in the deltoid muscle of 17 patients and in the gluteal muscle of 18 patients. Analysis indicated approximately equal rates of injection site pain between the two groups.

In a multiple-dose, parallel-arm study, researchers evaluated the safety, tolerability and pharmacokinetic parameters of aripiprazole after five monthly injections. The cohort included 141 patients, of which 138 received at least one 400 mg dose of aripiprazole in either the deltoid (n = 71) or gluteal (n = 67) muscle, and all subsequent doses were administered in the deltoid muscle of all patients.

Results from this study indicate injections in the deltoid muscle have comparable maximal- and minimal-plasma concentrations and aripiprazole exposures compared with injections in the gluteal muscle.

The most commonly observed adverse reactions to aripiprazole were increased weight, akathisia, injection site pain and sedation, according to results from a placebo-controlled trial.

“Having more choices and flexibility in the administration of Abilify Maintena for the treatment of schizophrenia may help strengthen the patient–physician alliance for the long-term management of the disease,” study researcher David Walling, PhD, chief executive officer of Collaborative Neuroscience Network, said in a press release. “It is important to offer an administration option for the deltoid muscle, in addition to the gluteal muscle, because some patients and physicians prefer the deltoid muscle site for injection.”