FDA Approves Long-Acting Schizophrenia Treatment

The FDA has approved Alkermes’ extended-release aripiprazole lauroxil injection (Aristada) for the treatment of schizophrenia in adults.

Aristada is the first atypical antipsychotic with once-monthly and 6-week dosing options, allowing the drug to maintain its therapeutic benefits for an extended period of time and enabling healthcare providers to better track patient adherence.

“Long-acting medications to treat schizophrenia can improve the lives of patients,” said Mitchell Mathis, MD, director of the FDA’s Division of Psychiatry Products, in a press release. “Having a variety of treatment options and dosage forms available for patients with mental illness is important so that a treatment plan can be tailored to meet the patient’s needs.”

The agency based its nod on data from a phase 3 study in which the safety and efficacy of Aristada were demonstrated in 622 patients with acute schizophrenia who had been stabilized with oral aripiprazole. Trial researchers found that multiple dose strengths of the drug successfully reduced schizophrenia symptoms at 12 weeks compared with placebo.

The most common adverse events reported by trial participants treated with the drug include akathisia, insomnia, and headache. Like other atypical antipsychotics, Aristada is not indicated for the treatment of dementia-related psychosis, and includes a Boxed Warning alerting health care professionals about the increased risk of death associated with this off-label use.

Aristada is the second schizophrenia treatment receive the FDA’s approval in the past month, as the agency previously gave its nod to Forest Laboratories’ cariprazine (Vraylar). Generic versions of extended-release paliperidone (Invega), another atypical antipsychotic, were also recently launched by Allergan and Mylan.