Schizophrenia Regimen Approved by FDA


Officials with the FDA have approved an Alkermes aripiprazole lauroxil (Aristada Initio) extended-release product for the treatment of schizophrenia in adults, according to the company.

Officials with the FDA have approved an Alkermes aripiprazole lauroxil (Aristada Initio) extended-release product for the treatment of schizophrenia in adults, according to the company. Aristada Initio leverages proprietary NanoCrystal technology, and the drug utilizes a smaller particle size than Alkermes’ Aristada, an injectable atypical antipsychotic medication that also contains aripiprazole lauroxil.

Although Aristada and Aristada Initio both contain aripiprazole lauroxil, the 2 medications are not interchangeable because of differing pharmacokinetic profiles. Aristada Initio provides faster dissolution, and leads to more rapid achievement of relevant levels of aripiprazole. Aristada Initio is expected to be available in mid-July.

Previously, the standard initiation regimen for Aristada included 21 consecutive days of oral aripiprazole starting with the first dose. The Aristada Initio regimen provides patients with relevant levels of aripiprazole within 4 days of initiation. The result is an alternative initiation regimen that gives health care providers an additional tool to support patients during this critical time in their treatment journey, according to the company.

"The approval of Aristada Initio makes Aristada the first and only long-acting atypical antipsychotic that can be initiated on day 1, representing an important addition to the treatment paradigm for the complex illness of schizophrenia," said David Walling, PhD, Chief Executive Officer and Principal Investigator of the Collaborative Neuroscience Network, in a statement released by Alkermes. "For physicians and caregivers alike, the Aristada Initio regimen provides a level of confidence that patients can walk out the door with up to two months of coverage with a proven medication in their system. This supports continuity of care for patients and allows the care team to focus their efforts on other aspects of the treatment paradigm that contribute to long-term positive outcomes."

Aristada Initio can be used for initiation onto any dose of Aristada (441 mg, 662 mg or 882 mg monthly, 882 mg once every 6 weeks and 1064 mg once every 2 months), offering a wide range of flexible dosing options for patients, and health care providers. The first Aristada dose may be administered on the same day as Aristada Initio or up to 10 days thereafter.

"Long-acting injectable atypical antipsychotics have an increasingly recognized role in the treatment of schizophrenia. The ability to initiate Aristada on day 1 may be particularly useful in the hospital setting, where more than 1/3 of patients initiate onto long-acting therapies," said Craig Hopkinson, MD, Chief Medical Officer and Senior Vice President of Medicines Development and Medical Affairs at Alkermes, in a statement. "The approval of Aristada Initio adds an important new option to our growing schizophrenia portfolio and reaffirms Alkermes' commitment to developing innovative treatments that address the real-world needs of people living with schizophrenia."


FDA Approves ARISTADA INITIO™ for the Initiation of ARISTADA® for Schizophrenia [news release]. Dublin: July 2, 2018; Alkermes website. Accessed July 2, 2018.

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