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FDA approves 2-month dosing option of Aristada for schizophrenia
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The FDA today approved 2-month Aristada, an extended-release injectable suspension, to treat schizophrenia.
“We designed Aristada to offer flexibility to meet the real-world needs of patients suffering from schizophrenia and the health care professionals providing their care,” Elliot Ehrich, MD, executive vice president of research and development at Alkermes, said in a company press release. “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 individual needs of their patients.”
Aristada (aripiprazole lauroxil, Alkermes) is now available in four doses and three dosing durations, including 441 mg, 662 mg or 882 mg once monthly, 882 mg once every 6 weeks, and 1,064 mg once every 2 months.
The new dosage will be available in mid-June, according to the release.
Safety and efficacy of the 2-month dosing interval was demonstrated in a randomized, open-label trial among 140 individuals with stable schizophrenia.
Study participants received 441 mg of aripiprazole once per month, 882 mg every 6 weeks or 1,064 mg every 2 months.
Participants who received the 2-month dosage exhibited clinically relevant plasma concentrations of aripiprazole and a pharmacokinetic profile that supported dosing once every 2 months, according to a press release.
“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 health care providers, caregivers and patients,” Joseph McEvoy, MD, of Augusta University and Duke University Medical Center, said in the release. “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.”