Sumitomo’s ulotaront failed to meet primary endpoints in two Phase III trials. Credit: Lightspring via Shutterstock.

Results published in the journal CNS Drugs by Otsuka and Lundbeck demonstrate that long-acting injectable, aripiprazole 2-month offers comparable tolerability, safety, and therapeutic plasma levels as aripiprazole 1-month for maintenance treatment of schizophrenia and bipolar disorder (BP-1).

The trial was over 32-weeks (031-201-00181) involving 266 patients. The investigational drug at 960mg dose showed positive therapeutic maintenance when compared to repeated monthly dosing at 400mg.

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Aripiprazole 2-month, intended for intramuscular injection, met the primary endpoints of drug plasma concentration and efficacy to aripiprazole one-monthly over a two-month dosing interval.

Aripiprazole 1-month is currently approved in adult patients for treatment of schizophrenia or the maintenance treatment of BP-1. Aripiprazole has been filed for approval in Europe, Canada, and the US.  If approved, it would add a needed spark in a challenged treatment field.

“Long-acting injectables are associated with less frequent symptom relapses and hospitalizations in those with complex psychiatric conditions,” said John Kraus MD PhD., executive vice president and chief medical officer at Otsuka.

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“The results of this study demonstrate that the extended dosing interval option of aripiprazole could provide clinicians with an effective potential treatment option for patients who may have greater challenges with medication adherence or access to treatment.”

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Aripiprazole has faced controversy, due to compulsive urge side effects not being communicated effectively to patients taking the medication. In 2016, the U.S. Food and Drug Administration (FDA)  issued a safety announcement highlighting that urges to gamble, binge eat, shop and have sex had been reported with use of aripiprazole.