FDA Approves New Treatment for Schizophrenia

Alkermes plc announced that the US Food and Drug Administration has approved Aristada (aripiprazole lauroxil) extended-release injectable suspension for the treatment of schizophrenia. This atypical antipsychotic will offer once-monthly and six-week dosing options for delivering and maintaining therapeutic levels of medication in the body through an injection.

The FDA approved Aristada based on safety and efficacy data from a phase 3 clinical trial involving 623 patients with schizophrenia. According to a news release from Alkermes, “multiple dose strengths of Aristada met the primary endpoint with statistically significant and clinically meaningful reductions in Positive and Negative Syndrome Scale (PANSS) total scores at Week 12, met the key secondary endpoint and demonstrated significant improvements in schizophrenia symptoms versus placebo.”

The most common adverse events reported by patients in the trial were insomnia, akathisia and headache.

The results of the phase 3 study were published in the August 2015 issue of The Journal of Clinical Psychiatry.

According to Elliot Ehrich, MD, Chief Medical Officer of Alkermes, Aristada was “designed to offer flexibility to meet the real-world needs of patients suffering from schizophrenia and the healthcare professionals providing their care.”

In the news release announcing the approval of Aristada, David Henderson, MD, Associate Professor of Psychiatry at Massachusetts General Hospital, said, “Schizophrenia is a serious and debilitating disease where, despite the existence of many medicines, there remains significant unmet medical need and suffering. New treatment options are needed to help patients and their families better manage this illness. Long-acting therapies are rapidly evolving to the forefront of the treatment of schizophrenia as clinicians increasingly recognize the potential benefits of less frequent dosing and consider their use earlier in disease progression.”

Aristada is not approved for the treatment of patients with dementia-related psychosis. Treatment with Aristada may also be associated with increased incidence of cerebrovascular adverse reactions, such as stroke and transient ischemic attack.