FDA approves expanded label of Abilify Maintena

Otsuka America Pharmaceutical Inc. and Lundbeck said the FDA has approved the expanded label of Abilify Maintena® (aripiprazole) for extended-release injectable suspension. The new deltoid injection site is for caregivers administering Abilify Maintena to patients with schizophrenia.

The medication is the only once-monthly injection of a dopamine D2 partial agonist for patients with schizophrenia. Previously the only allowed injection site as in the gluteal area.

“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,” said study investigator David Walling, Ph.D., chief executive officer and principal investigator, CNS Network. “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.”

This new deltoid administration offering for Abilify Maintena is scheduled to be available in the fall.