Tuesday, June 6, 2017

FDA Approves Two-Month Dose of Aristada for Treatment of Schizophrenia

Clinicians will soon be able to offer patients with schizophrenia the option to extend the amount of time between injections of the atypical antipsychotic Aristada (aripiprazole lauroxil). The Food and Drug Administration (FDA) yesterday approved a two-month dose of Aristada for the treatment of schizophrenia.

Aristada, manufactured by Alkermes, was first approved by the FDA in October 2015, with dosages for use every four to six weeks. In August 2016, Alkermes submitted a supplemental New Drug Application (sNDA) to the FDA for a two-month dosing interval of Aristada. The application was based on the results of an open-label trial that compared outcomes in 140 patients with stable schizophrenia who were randomized to receive 441 mg aripiprazole once per month, 882 mg aripiprazole every six weeks, or 1,064 mg aripiprazole every two months.

“Results from the study showed that the 1,064-mg dose of aripiprazole achieved therapeutically relevant plasma concentrations of aripiprazole with a PK [pharmacokinetics] profile that supports dosing once every two months. The most common adverse event for the two-month dosing interval was injection site pain,” the company reported at the time.

“Aristada is now FDA approved in four doses and three dosing-duration options (441 mg, 662 mg, or 882 mg once monthly; 882 mg once every six weeks; and 1,064 mg once every two months) and can be initiated at any dose or interval, offering an unprecedented range of flexibility to patients and health care providers,” according to a press release issued by Alkermes today.

“The availability of an antipsychotic that can be initiated prior to hospital discharge and provide therapeutic levels of medication for two months will be a welcome new treatment option for health care providers, caregivers, and patients,” Joseph McEvoy, M.D., the I. Clark Case Distinguished Chair in Psychotic Disorders at Augusta University and professor emeritus of psychiatry and behavioral health at Duke University Medical Center, said in the Alkermes press release.

According to Alkermes, the two-month dose of the medication is expected to be available in mid-June.

For related news, see the Psychiatric News article “Study Finds Aripiprazole Lauroxil Carries Low Risk of Metabolic Side Effects.”

For related information on long-acting injectables, see the Psychiatric Services article “Hospital Readmission Rates Among Patients With Schizophrenia Treated With Long-Acting Injectables or Oral Antipsychotics.”

(Image: iStock/Ca-ssis)


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