Rexulti, an antipsychotic drug used to treat schizophrenia, has been approved by the U.S. Food and Drug Administration. Rexulti is manufactured by the Danish drug maker H. Lundbeck A/S and Otsuka Pharmaceutical Co. Ltd. in Japan.
The FDA also approved the use of the Rexulti (brexpiprazole) as an add-on therapy to treat major depressive disorder in adults. Dr. Mitchell Mathis of the FDA said he believes it is important to have multiple options available in the form of drugs to treat patients with schizophrenia, depression and other mental disorders.
The FDA approved Rexulti based on results of the two clinical trials that lasted six weeks. The trials involved nearly 1,300 subjects, out of which some were given the new drug, while the others took the placebo. The researchers found that those who took the drug showed fewer symptoms of schizophrenia as compared to those who took the placebo.
The drug was also tested on more than 1,000 patients who suffered from chronic depression during two six-week clinical trials. The condition of the patients was such that an antidepressant alone was not able to treat the symptoms associated with depression.
Half of the subjects were treated with Rexulti in addition to the antidepressant while the remaining subjects took the placebo along with the antidepressant drug. The former group showed fewer symptoms as compared to the latter.
The box of Rexulti, like those of other antipsychotic drugs, displays a warning about the increased risk of suicidal thoughts and deaths from consuming the unprescribed amounts of the drug. The FDA warned people on Rexulti should be regularly monitored for development of suicidal thoughts or tendencies.