Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announced the U.S. Food and Drug Administration (FDA) has approved ABILIFY MAINTENA™ (aripiprazole) for extended- release injectable suspension, an intramuscular (IM) depot formulation indicated for the treatment of schizophrenia.
ABILIFY MAINTENA is the first dopamine D2 partial agonist approved as a once- monthly injection. It contributes a new treatment option to address the ongoing need for relapse prevention in patients with schizophrenia - a chronic, debilitating disease.
Efficacy was demonstrated in a 52-week, placebo-controlled, double-blind, randomized-withdrawal, Phase 3 maintenance trial of ABILIFY MAINTENA in patients with schizophrenia. The time to relapse was the primary endpoint. In the trial, ABILIFY MAINTENA>1 In a key secondary endpoint, the percentage of subjects experiencing relapse (i.e., meeting clinical trial criteria for exacerbation of psychotic symptoms/relapse) was also significantly lower with ABILIFY MAINTENA compared to placebo at the end of the study (10% vs. 40%, respectively; p<0.0001). Additional support for efficacy was derived from oral aripiprazole trials.
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ABILIFY MAINTENA is not approved for the treatment of patients with dementia-related psychosis. ABILIFY MAINTENA is contraindicated in patients with a known hypersensitivity reaction to aripiprazole. Reactions have ranged from pruritus/urticaria to anaphylaxis (see Important Safety Information below).
ABILIFY MAINTENA will be the first commercialized product from the long-term global alliance between Otsuka and Lundbeck to develop CNS medicines worldwide. The companies expect the product will start becoming available in the U.S. on March 18.
"Protection from relapse of schizophrenia is important for patients, their families and the communities in which they live," said study investigator John M. Kane, M.D., Chairman of Psychiatry, The Zucker Hillside Hospital, and Vice President, Behavioral Health Services, North Shore-LIJ Health System. "As a strong believer in long-acting therapies for schizophrenia, I think it is important for physicians to have a new and effective once-monthly treatment option that can help reduce the risk of relapse and manage symptoms in patients."
Results from the clinical trial of ABILIFY MAINTENA were published in the Journal of Clinical Psychiatry and first presented in four poster presentations at the 2012 American Psychiatric Association Annual Meeting in May 2012.
The trial included adult patients who met DSM-IV-TR criteria for schizophrenia and who were being treated with at least one antipsychotic medication. Patients had at least a 3-year history of illness and a history of relapse or symptom exacerbation when not receiving antipsychotic treatment. Patients in the study received injections of ABILIFY MAINTENA or placebo once every four weeks; the first injection was accompanied by two weeks of concomitant administration of oral aripiprazole. The trial included a pre-planned interim analysis which demonstrated a significantly longer time to relapse (p<0.001) in patients randomized to the ABILIFY MAINTENA group compared to placebo-treated patients. The trial was subsequently terminated early by an independent data monitoring committee because maintenance of efficacy was demonstrated. The final analysis demonstrated a statistically significantly longer time to relapse in patients randomized to the ABILIFY MAINTENA group than compared to placebo- treated patients (log-rank test p<0.0001).