FDA approves Aristada Initio for use as therapy with Aristada in schizophrenia.- Alkermes.

Alkermes announced that the FDA has approved Aristada Initio (aripiprazole lauroxil) for the initiation of Aristada (aripiprazole lauroxil), a long-acting injectable atypical antipsychotic for the treatment of schizophrenia in adults. For the first time, Aristada Initio, in combination with a single 30 mg dose of oral aripiprazole, provides physicians with an alternative regimen to initiate patients onto any dose of Aristada on day one. Aristada Initio is expected to be available in mid-July.

For people living with schizophrenia, medication compliance and continuity of care can be challenging and the transition from inpatient care to outpatient settings can be an especially vulnerable time. Previously, the standard initiation regimen for Aristada included 21 consecutive days of oral aripiprazole starting with the first Aristada dose. The Aristada Initio regimen provides patients with relevant levels of aripiprazole within four days of initiation. The result is an alternative initiation regimen that gives healthcare providers an additional tool to support patients during this critical time in their treatment journey.

Aristada and Aristada Initio both contain aripiprazole lauroxil; however, the two medications are not interchangeable because of differing pharmacokinetic profiles. Aristada Initio leverages the company's proprietary NanoCrystal technology and is designed to provide an extended-release formulation using a smaller particle size of aripiprazole lauroxil compared to Aristada, thereby enabling faster dissolution and leading to more rapid achievement of relevant levels of aripiprazole. Aristada Initio can be used for initiation 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), offering a wide range of flexible dosing options for patients and healthcare providers. The first Aristada dose may be administered on the same day as Aristada Initio or up to 10 days thereafter.