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FDA Approves Atypical Antipsychotic Aristada

Extended-release injectable for schizophrenia

The FDA has approved Aristada (aripiprazole lauroxil) extended release injection to treat adults with schizophrenia.

Indications: Aristada is an atypical antipsychotic indicated for the treatment of schizophrenia.

Dosage and administration: Aristada is only to be administered as an intramuscular injection by a healthcare professional. For patients who have never taken aripiprazole, establish tolerability with oral aripiprazole prior to initiating treatment with Aristada. Due to the half-life of oral aripiprazole, it may take up to 2 weeks to fully assess tolerability. Refer to the prescribing information of oral aripiprazole for the recommended dosage and administration of the oral formulation. Depending on individual patient’s needs, treatment with Aristada can be initiated at a dose of 441 mg, 662 mg, or 882 mg administered monthly, which corresponds to 300 mg, 450 mg, and 600 mg of aripiprazole, respectively. Treatment may also be initiated with the 882 mg dose every 6 weeks.

Efficacy and safety: The efficacy of Aristada was established in a 12-week, randomized, double-blind, placebo-controlled, fixed-dose study in 622 adult patients with schizophrenia. Statistically significant separation from placebo on PANSS total score change was observed in each Aristada dose group.

Side effects/risks: Most commonly observed adverse reaction was akathisia.

Source: Highlights of Prescribing Information.

http://aristada.com/hcp/ARISTADA-prescribing-information.pdf. Accessed October 7, 2015.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm465801.htm?.... Accessed October 7, 2015.