FDA Approves New Dosage for Schizophrenia Drug

The US Food and Drug Administration (FDA) has approved a new 2-month dosage for Alkermes’ aripiprazole lauroxil (Aristada), an extended-release injectable suspension for the treatment of schizophrenia.

First approved by the FDA in October 2015, the drug’s most recent 2-month dosing approval means it will be available in four total doses with three options for dosing duration — 441 mg, 662 mg, or 882 mg once per month; 882 mg once every 6 weeks; and 1064 mg once every 2 months.

“The clinical community is increasingly using long-acting atypical antipsychotic medications earlier in the treatment paradigm as recognition grows of the benefits of less frequent dosing and the resulting ability to focus on other important treatment goals for patients,” said Joseph McEvoy, MD, I. Clark Case distinguished char in psychotic disorders at Augusta University and professor emeritus of psychiatry and behavioral health at Duke University Medical Center.

For patients on daily therapy for chronic diseases, treatment adherence is a known challenge — one that schizophrenia makes even more difficult. According to Alkermes, long-acting injectable medications like aripiprazole lauroxil eliminate the burden of taking oral antipsychotic medicines on a daily basis, and can limit dosing to only six injections per year.

“Transitioning patients with schizophrenia from inpatient care to outpatient settings can be challenging. The availability of an antipsychotic that can be initiated prior to hospital discharge and provide therapeutic levels of medication for 2 months will be a welcome new treatment option for healthcare providers, caregivers, and patients,” McEvoy said.

Arpiprazole lauroxil is indicated for the treatment of schizophrenia. It is contraindicated in patients with known hypersensitivity reactions to aripiprazole. Reactions have ranged from pruritus/urticarial to anaphylaxis.

The drug increases mortality in elderly patients with dementia-related psychosis, and is not approved in those patients.

“We designed Aristada to offer flexibility to meet the real-world needs of patients suffering from schizophrenia and the healthcare professionals providing their care. As the first and only-long-acting atypical antipsychotic approved in three dosing durations and with the ability to initiate treatment at any dose or duration, Aristada provides a range of options to help clinicians tailor treatment to the individuals needs of their patients,” said Elliot Ehrich, MD, executive vice president, research and development at Alkremes.

The newest 2-month dose of aripiprazole lauroxil is expected to be available in mid-June, according to an Alkermes statement.