Aristada (aripiprazole lauroxil) extended release injection has been approved by the U.S. Food and Drug Administration to treat the disabling brain disorder schizophrenia, the agency said Tuesday in a news release.
Schizophrenia, affecting about one percent of Americans, typically has symptoms including hearing voices that aren’t real, believing other people are controlling one’s mind or thoughts, and paranoia. Symptoms are commonly first seen among people under age 30.
Aristada’s effectiveness was demonstrated in a 12-week clinical study involving 622 people. As with other drugs in this class, known as “atypical antipsychotics,” the medication includes a boxed warning against off-label use that may increase the risk of death among older people with dementia-related psychosis.
The new drug’s most common side effect is the feeling the need to move constantly, medically called akathisia.
Aristada is manufactured by Alkermes, Inc., based in Waltham, Mass.
To learn more, visit the FDA.