FDA Approves Aristada Initio for Same-Day Schizophrenia Treatment

The new formulation allows patients with schizophrenia to begin treatment with just one oral dose of aripiprazole, achieving relevant levels in 4 days.

The US Food and Drug Administration has approved aripiprazole lauroxil (Aristada Initio, Alkermes) for the initiation of Aristada, a different formulation of aripiprazole lauroxil. Aristada Initio, taken in combination with a single 30 mg oral dose of aripiprazole, allows physicians to initiate patients onto any dose of Aristada immediately.

Aripiprazole lauroxil was first approved by the FDA for the treatment of schizophrenia in October 2015 at monthly and 6-week dosing options. In June 2017, the FDA extended the approval to a new 2-month dosage of the injectable schizophrenia drug.

Though the drug itself is not novel, the company’s nanocrystal technology is used in Aristada Initio to provide an extended-release formulation with a smaller particle size. The nanocrystal particles allow for a more rapid dissolution compared to Aristada that leads to appropriate levels of aripiprazole more quickly.

Instead of the standard initiation regimen of 21 days of oral aripiprazole beginning with the Aristada injection, Aristada Initio requires only 1 oral dose that can be given the same day as the injection. The Aristada Initio initiation regimen allows for relevant levels of aripiprazole within 4 days.

"The approval of Aristada Initio makes Aristada the first and only long-acting atypical antipsychotic that can be initiated on day one, 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.

Aristada Initio may be used to initiate a patient onto any dose of Aristada (441 mg, 662 mg or 882 mg monthly, 882 mg once every six weeks and 1064 mg once every two months). The first dose of Aristada can be injected on the same day as Aristada Initio or up to 10 days later.

"Long-acting injectable atypical antipsychotics have an increasingly recognized role in the treatment of schizophrenia. The ability to initiate Aristada on day one may be particularly useful in the hospital setting, where more than one-third 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.

At the American Psychiatric Association’s annual meeting in May 2018, Walling spoke of the Aristada Initio nanocrystal delivery system and how important the same-day initiation option is for patients with schizophrenia who may have challenges in taking a daily oral medication while initiating Aristada.

“I think that what we did is exciting because it gives you comfort in knowing that your subject is getting the medication that they need prior to them leaving the hospital,” said Walling. Read the full transcript of Walling’s discussion here.

"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,” added Walling in the statement.

The company expects that Aristada Initio will be available beginning in mid-July 2018.