2 July 2018 - Novel regimen enables physicians to fully dose up to two months of Aristada treatment on day one.

Alkermes today announced that the U.S. 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.

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.

Read Alkermes press release