Injectable schizophrenia drug gets FDA green light

FDA has approved aripiprazole lauroxil (Aristada, Alkermes) extended-release injectable suspension for the treatment of adults with schizophrenia.

Related: FDA accepts NDA for first 'digipill'

Schizophrenia is a chronic, severe and disabling brain disorder. A person with schizophrenia may have difficulty distinguishing between what is real and what is not. Schizophrenia is characterized by presence of positive symptoms such as elusions or hallucinations, as well as negative symptoms such as emotional unresponsiveness. According to the National Alliance on Mental Illness, an estimated 2.4 million American adults have schizophrenia, with men and women affected equally.

Aristada is the first injectable atypical antipsychotic with once-monthly and 6-week dosing options to treat schizophrenia in adults. The injection must be given by a healthcare professional and is administered in the arm or buttocks. Long-acting injectable antipsychotics provide patients with blood concentrations of active drug that remain within a therapeutic range for an extended period of time and help to ensure patient adherence.

Related:FDA approves cariprazine for treatment of schizophrenia

Aristada's safety and efficacy were demonstrated in a randomized, double-blind, placebo-controlled, phase 3 study that included 623 adult patients with schizophrenia. Results showed that, in patients stabilized with oral aripiprazole, Aristada produced statistically and clinically significant reductions in Positive and Negative Syndrome Scale (PANSS) total scores at week 12 as compared to placebo.

“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,” said David Henderson, MD, associate professor of psychiatry at Massachusetts General Hospital, in a press release. “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.”

Insomnia, restlessness, and headache were the most common adverse events associated with the use of Aristada in the study. Similar to other atypical antipsychotics, the drug has a boxed warning alerting healthcare professionals of the increased risk of death with use in the treatment of dementia-related psychosis in the elderly.

Alkermes is preparing to launch Aristada immediately.

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