The U.S. Food and Drug Administration (FDA) has granted approval to an antipsychotic drug called brexpiprazole (Rexulti), which is used to treat schizophrenia, FDA Monday news release stated.
The drug, manufactured by Japan's Otsuka Pharmaceutical Company Ltd., was also approved for use as an add-on treatment for major depressive disorder (MDD) in adults.
Schizophrenia and MDD are disabling conditions that can affect daily activities, according to Mitchell Mathis, director of the agency's Division of Psychiatry Products.
Mathis also said in the release that it is important to have a wide variety of options for treatment since medications have different effects on different people.
The move to approve the drug for the management of schizophrenia is based on two clinical trials that lasted for six weeks each and performed on over 1,300 participants.
People who received the treatment reported fewer schizophrenia symptoms compared to those who received a placebo drug, according to the FDA news release.
When it comes to treating MDD, brexpiprazole was seen to be effective in reducing depression symptoms based on two six-week clinical trials on more than 1,000 participants.
In this set of trial, it compared the results of Rexulti with an antidepressant and a placebo with an antidepressant.
The most commonly reported side effects from using the drug are sense of restlessness and weight gain.
As with other schizophrenia medications, Rexulti carries a boxed warning stating an increased death risk if drug is used for unapproved conditions.
The warning also states that patients and health care professionals should be aware of the increased risk of suicidal tendencies among the young population taking the drug.
The FDA also advised that those who take Rexulti should be monitored if suicidal behavior and thoughts start or worsen.
The act of dispensing Rexulti should come with a patient Medication Guide, which carries important details on the risks and proper use of the drug.
