Otsuka Pharmaceutical (TYO:4578) and Lundbeck said last week that its extended-release injectable aripiprazole suspension, Abilify Maintena, won FDA approval as a maintenance monotherapy for adults with bipolar I disorder.
The once-monthly intramuscular formulation was created by Otsuka and co-developed and commercialized with Lundbeck, the companies reported.
A late-stage trial showed that Abilify Maintena delayed the time to recurrence of a mood episode in adults experiencing a manic episode compared to a placebo.
“Bipolar I disorder is a recurrent chronic mental illness. Abilify Maintena provides healthcare professionals a new treatment option for their patients who have established tolerability with oral aripiprazole,” Dr. Joseph Calabrese, director of the Mood Disorders Program at University Hospitals Cleveland Medical Center, said in prepared remarks. “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.”
Patients enrolled in the Phase III trial of Abilify Maintena were experiencing a manic episode at trial entry and met the criteria for bipolar I disorder. The participants also had a history of at least one previous manic or mixed episode with symptoms that required either hospitalization, treatment with a mood stabilizer and/or treatment with an anti-psychotic agent.
The 52-week trial showed significant differences between groups in delaying time to recurrence of both manic and mixed episodes, but there was no significant difference in depressive mood episodes, according to the companies.