- Planters Peanut Products Under Recall Due to Listeria Risk
- That ‘New Car Smell’ Could Be Toxic Carcinogens
- Gene Discovery Points to a New Form of Alzheimer’s
- Scientists May Have Located Your Brain’s ‘Neural Compass’
- Almost All Counterfeit Oxycontin Pills Contain Fentanyl
- A Parent’s Watchful Eye Does Keep Kids From Drugs, Alcohol: Study
- AI Might Boost Detection of A-Fib
- Drug May Help Folks Kick the Vaping Habit
- Small Pump May Let Kids Stay Home As They Await New Heart
- Gene Therapy Improves Vision in People With Inherited Blindness
Rexulti Approved for Schizophrenia, Depression
Rexulti (brexpiprazole) has been approved by the U.S. Food and Drug Administration to treat schizophrenia, and as an add-on drug for major depressive disorder (MDD) when a first-line drug fails to effectively treat symptoms.
Schizophrenia is a chronic, disabling brain disorder that primary affects people aged 30 and younger. Affecting about 1 percent of Americans, the disorder is characterized by hearing voices, believing other people are reading your mind, withdrawal and suspicion.
MDD, commonly called depression, is characterized by unhappy mood that interferes with a person’s ability to carry on life’s daily activities. Other symptoms may include loss of interest in daily life, weight change, insomnia, restlessness, fatigue, feeling guilty or worthless, and inability to concentrate.
Clinical studies evaluating the drug for both disorders involved more than 2,300 people. The most common side effects included weight gain and feeling the need to move.
Rexulti and other drugs approved to treat schizophrenia include a boxed label warning of the increased risk for death if prescribed for the off-label use to treat behavioral problems in older people with dementia-related psychosis.
The boxed warning also expresses caution on the potential for increased suicidal thinking and behavior among children and young adults, a warning common to most antidepressants, the FDA said.
Rexulti is produced by Otsuka Pharmaceutical Co., based in Tokyo.
More information
The FDA has more about this approval.
Source: HealthDay
Copyright © 2024 HealthDay. All rights reserved.