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FDA Approves Initiation Drug for Schizophrenia

Alkermes plc news release; 2018 Jul 2

Alkermes plc has announced that the US Food and Drug Administration (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 1. Alkermes plc is headquartered in Dublin, Ireland.

Indications: Aristada Initio, in combination with oral aripiprazole, is indicated for the initiation of Aristada when used for the treatment of schizophrenia in adults.

Dosage/administration: The recommended dosage is 1 675 mg injection of Aristada Initio and 1 30 mg dose of oral aripiprazole in conjunction with the first Aristada injection. Aristada Initio is only to be used as a single dose and is not for repeated dosing. It should be administered by intramuscular injection in either the deltoid or gluteal muscle by a healthcare professional. For patients naïve to aripiprazole, tolerability with oral aripiprazole prior to initiating treatment with Aristada Initio should be established.

Adverse reactions: The most commonly observed adverse reaction (incidence ≥5% and at least twice that for placebo) was akathisia.

Citation:

FDA approves Aristada Initio for the initiation of Aristada for schizophrenia. [news release]. Dublin, Ireland: Alkermes plc. July 2, 2018. https://www.prnewswire.com/news-releases/fda-approves-aristada-initio-for-the-initiation-of-aristada-for-schizophrenia-300675138.html. Accessed July 6, 2018.

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