Lundbeck Reports Positive Abilify Maintena Trial Results For Schizophrenia

Lundbeck and Otsuka reported positive results from the final analysis of a mirror-image study of Abilify Maintena (aripiprazole) in patients with schizophrenia against daily oral antipsychotics.

Once-monthly Abilify Maintena (400 mg prolonged release suspension for intramuscular injection of aripiprazole) demonstrated a ten-fold reduction in hospitalization rates when the same patients with previous standard of care with oral antipsychotics were compared in a mirror-image study design. The drug was well tolerated with a similar favorable profile as that of oral Abilify.

John M. Kane, Chairman of Psychiatry at The Zucker Hillside Hospital and investigator in the study, said, “Our ability to reduce the risk of relapse and re-hospitalization is critical in facilitating improvement in psychosocial and vocational functioning. With each relapse patients can lose hard won gains and find it more and more difficult to progress towards recovery.”

Hospitalizations related to schizophrenia are a common result of relapses. Reducing the risk of recurring relapses and readmissions early in the course of the illness may help minimize its negative impact on a patient’s long term prognosis and quality of life. Protection from relapse and hospital readmissions is a major goal in patient management. “In previous studies, long-acting injectable (LAIs) antipsychotics have demonstrated significant reductions in the risk of hospitalization compared with oral antipsychotics and may be particularly beneficial for patients with first-episode psychosis. In patients hospitalized for the first time, LAIs were shown to reduce the risk of readmission by 64 percent compared with oral formulations,” Lundbeck stated in its press release.

Aripiprazole is the only dopamine D2 partial agonist once-monthly injectable form to receive approval for maintenance treatment of schizophrenia. The drug is approved in the U.S. for treatment of schizophrenia and in several European countries, as well as in Canada for maintenance treatment of schizophrenia.

The findings were presented at the 4th Biennial Schizophrenia International Research Society (SIRS) conference in Florence, Italy this month.