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FDA approves Abilify for bipolar I disorder maintenance monotherapy
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Otsuka Pharmaceutical Co. Ltd. and Lundbeck recently announced the FDA approved extended-release injectable suspension Abilify Maintena for maintenance monotherapy of bipolar I disorder in adults.
"The study was conducted in Otsuka and Lundbeck’s commitment to continued research in serious mental illness and bringing new treatment options to patients," Robert McQuade, chief strategic officer of Otsuka Pharmaceutical, told Healio/Psychiatry. "The approval of Abilify Maintena for maintenance monotherapy treatment for bipolar I disorder in adults represents the first once-monthly injectable formulation of an antipsychotic to be approved for this patient population. The only other long-acting injectable atypical antipsychotic approved by the FDA for the maintenance treatment of [bipolar I disorder] requires administration every 14 days. This approval provides patients with bipolar I disorder with an important new treatment option for the maintenance monotherapy treatment of their disease."
Abilify Maintena (aripiprazole, Otsuka America Pharmaceutical Inc., Lundbeck) is a once-monthly injectable formulation for intramuscular use.
The approval is based on phase 3 findings that indicated Abilify Maintena delayed time to recurrence of mood episode in adults with manic episodes.
To assess efficacy and safety of once-monthly Abilify Maintena for maintenance treatment of bipolar I disorder, researchers conducted a 52-week, phase 3, double-blind, randomized withdrawal trial among adults with bipolar I disorder who experienced a manic or mixed episode that required hospitalization.
Overall, study participants who received aripiprazole had significantly longer times to recurrence of any mood episode, compared with placebo (HR = 0.451; 95% CI, 0.299-0.678; P < .0001).
During the randomized phase, there was a significantly lower proportion of participants with recurrence of any mood episode in the aripiprazole group (26.5%) vs. the placebo group (51.1%), due to reductions in manic recurrences.
Participants who received aripiprazole exhibited statistically significant improvement in Clinical Global Impression-Bipolar Version-Severity mania scores (P = .0011) and time to hospitalization was significantly longer, compared with placebo (P = .0002).
During the stabilization phase, treatment-emergent adverse events included akathisia (17.4%), weight increase (11.1%), insomnia (9.6%), anxiety (7.1%), restlessness (5.6%), fatigue (5.2%), and nasopharyngitis (5.2%).
Abilify Maintena is not approved for treatment among individuals with dementia-related psychosis.
"Abilify Maintena, the first FDA approved, once-monthly, long-acting injectable for the maintenance monotherapy treatment of adult bipolar I disorder patients, impacts the psychiatric clinical practice as it provides healthcare professionals a new treatment option for patients with bipolar I disorder, a highly recurrent chronic mental illness," Joseph Calabrese, MD, of University Hospitals Cleveland Medical Center, and Case Western Reserve University School of Medicine told Healio/Psychiatry. "For patients, the impact of this approval means that those receiving Abilify Maintena each month, as prescribed and administered by a healthcare professional, have the 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."