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Rexulti FDA Approval History

FDA Approved: Yes (First approved July 10, 2015)
Brand name: Rexulti
Generic name: brexpiprazole
Dosage form: Tablets
Company: Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S
Treatment for: Schizophrenia, Depression

Rexulti (brexpiprazole) is a serotonin-dopamine activity modulator (SDAM) for the treatment of schizophrenia and the adjunctive treatment of major depressive disorder.

Schizophrenia is a chronic mental illness that can cause delusions and hallucinations. Major Depressive Disorder is a serious psychiatric condition that can lead to persistent feelings of sadness, frustration or anger. Rexulti is approved for use as monotherapy for the treatment of schizophrenia, and as adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD).

Rexulti is an atypical antipsychotic that works through a combination of partial agonist activity at serotonin 5-HT1A and dopamine D2 receptors, and antagonist activity at serotonin 5-HT2A receptors. It is considered a second generation version of aripiprazole (Abilify), and with slightly different activity at the serotonin and dopamine receptors, could mean an improved clinical profile with fewer side effects such as restlessness.

The safety and efficacy of Rexulti was studied in four completed placebo-controlled clinical phase III studies – two studies as adjunctive therapy to antidepressants in MDD and two studies in schizophrenia. Rexulti was demonstrated to be superior to placebo for both conditions at specific dosages.

Rexulti tablets are taken once daily with or without food. A lower dose is given to start, and then gradually increased over time to the target dosage.

Common side effects include weight gain and akathisia, an inner sense of restlessness.

Development timeline for Rexulti

Sep 23, 2016Approval U.S. FDA Approves Labeling Update of Rexulti (brexpiprazole) for Maintenance Treatment of Schizophrenia
Jul 10, 2015Approval FDA Approves Rexulti (brexpiprazole) for Schizophrenia and Adjunctive Treatment for Major Depressive Disorder
Apr 17, 2015Results of Phase III Study of Brexpiprazole in Adult Patients With Schizophrenia Published in American Journal of Psychiatry
Sep 24, 2014FDA Accepts Filing for Review of Brexpiprazole
Jul 14, 2014Otsuka and Lundbeck Submit NDA for Brexpiprazole

Further information

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