Otsuka and Lundbeck announced that the Food and Drug Administration (FDA) has approved Abilify Maintena (aripiprazole) extended-release injectable suspension for the maintenance monotherapy treatment of bipolar I disorder (BP-I) in adults.
Abilify Maintena contains an atypical antipsychotic for intramuscular injection given once monthly. It is already approved to treat schizophrenia and Tourette’s disorder in adult patients. Its efficacy, while unknown, may be mediated through a combination of partial agonist activity at dopamine D2 and serotonin 5-HT1A receptors and antagonist activity at 5-HT2A receptors.
Data from the 52-week, Phase 3, double-blind, placebo-controlled, randomized withdrawal study supported the FDA approval for maintenance monotherapy for the treatment of BP-I. The study enrolled patients who were experiencing a manic episode at screening and met the DSM-IV-TR criteria for BP-I. Patients also had a history of ≥1 previous manic or mixed episode with manic symptoms severe enough to require one of the pre-specified interventions.
The study’s primary endpoint showed Abilify Maintena significantly delayed the time to recurrence of any mood episode in adults having a manic episode at screening vs. placebo. Significant differences were observed between treatment arms in delaying time to recurrence of both manic and mixed episodes. No substantial differences, however, were seen for depressive mood episodes.
“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,” stated Joseph Calabrese, MD, Director of the Mood Disorders Program at University Hospitals Cleveland Medical Center.
Abilify Maintena is available as 300mg and 400mg strength powder for reconstitution in vials or as pre-filled syringes.
For more information call (800) 438-9927 or visit AbilifyMaintena.com.