FDA approves Aristada Initio for schizophrenia

David P. Walling

The FDA has approved Aristada Initio for the initiation of Aristada, a long-acting injectable atypical antipsychotic medication, to treat adults with schizophrenia, according to a press release.

In combination with a single 30-mg dose of oral aripiprazole, Aristada Initio (aripiprazole lauroxil, Alkermes) enables physicians to fully dose up to 2 months of Aristada (aripiprazole lauroxil, Alkermes) on day one of treatment with an alternative regimen, the release said.

According to the release, Aristada Initio is anticipated to be available in mid-July.

"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," David P. Walling, PhD, CEO and principal investigator of the Collaborative Neuroscience Network, said in the press release.

The Aristada Initio regimen delivers relevant levels of aripiprazole to patients within 4 days of beginning treatment, which may present an alternative to the 21-day initiation period required before beginning long-term Aristada therapy and gives health care professionals another tool to help patients during this time in treatment, according to the release.

“I think one of the things that we as clinicians worry about is whether or not patients are taking their medications, particularly during an acute episode,” Walling told Healio Psychiatry. “Most of the long-acting injectables on the market require an overlap with an oral medication in order to get subjects to therapeutic blood levels.”

Using Alkermes plc’s NanoCrystal technology, Aristada Initio provides an extended-release formulation via a smaller particle size of aripiprazole lauroxil than what is used in Aristada, thus enabling rapid dissolution, according to the release. 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 1,064 mg once every 2 months), and the first Aristada dose can be administered on the same day as Aristada Initio or up to 10 days later, per the release.

“The approval of Aristada Initio means that clinicians can be assured that patients rapidly get to therapeutic levels through the addition of an additional injection and a single 30mg tablet of [oral aripiprazole],” Walling told Healio Psychiatry. “In my mind, it takes the worry out of starting a subject on a long-acting injectable medication and also simplifies things for patients and their caregivers.” – by Savannah Demko

Disclosures: Walling reports grant/research support from Abbvie, Alkermes, Allergan, Avanir, Boehringer Ingelheim, CoMentis, IntraCellular, Janssen, J&J PRD, Lundbeck, Lupin, Novartis, Omeros, Otsuka, Pfizer, Roche, Sunovion, Takeda and Zogenix. He also reports consulting for Acadia, Janssen and Otsuka.