FDA Approves Atypical Antipsychotic Aristada

October 8, 2015

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 similar to Latuda.

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.

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

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

4 Likes

Cool seems like an upgrade from abilify maintena. Currently I take 300 mg abilify maintena monthly and 15 mg oral at night. Seems like this could add some convienance

Yes - more info here. This is basically identical to Abilify Maintena.

Just another way to keep a patent on Abilify and make money.

Sort of - Aristada is from a different company though - so its a competitor to the traditional (now Generic) Abilify / Aripiprazole and the newer (2013) Ablify Maintena injection medication.

Basically Alkermes is cashing in on the popularity of Abilify by making its own injectable version using the now generic / off-patent medication.