Rexulti Approval History
- FDA approved: Yes (First approved July 10th, 2015)
- Brand name: Rexulti
- Generic name: brexpiprazole
- Dosage form: Tablets
- Company: Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S
- Treatment for: Schizophrenia, Depression, Major Depressive Disorder
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 History and FDA Approval Process for Rexulti
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