FDA approves new drug for schizophrenia, bipolar disorder

September 18, 2015
FDA approves new drug for schizophrenia, bipolar disorder
Vraylar is an atypical antipsychotic taken once a day.

(HealthDay)—A new antipsychotic drug to treat schizophrenia and bipolar disorder in adults has been approved by the U.S. Food and Drug Administration.

The drug, Vraylar (cariprazine), is a capsule taken once a day.

"Schizophrenia and can be disabling and can greatly interfere with day-to-day activities," Dr. Mitchell Mathis, director of the division of psychiatry products in the FDA's Center for Drug Evaluation and Research, said in an agency news release.

"It is important to have a variety of treatment options available to patients with mental illnesses so that treatment plans can be tailored to meet a patient's individual needs," Mathis said.

Schizophrenia, a chronic and disabling brain disorder that usually develops in early adulthood, occurs in 1 percent of the general population, according to the U.S. National Institute of Mental Health. People with the condition often see or hear things that are not there. They are also withdrawn or paranoid, believing others are trying to read their mind or control their thoughts.

Vraylar belongs to a class of drugs known as atypical antipsychotics. Others in this group include Abilify (aripiprazole), Seroquel (quetiapine) and Risperdal (risperidone).

The drug's effectiveness in treating schizophrenia was tested among more than 1,750 patients in three six-week clinical trials. It was shown to reduce schizophrenia symptoms compared to the placebo. The drug's maker, Forest Labs, and distributor, Actavis Pharma, are based in New Jersey.

The most commonly reported side effects in the schizophrenia trials were tremor, slurred speech and involuntary muscle movements.

Bipolar disorder, also known as manic-depressive illness, leads to dramatic mood swings or shifts in energy and activity levels. People with bipolar disorder have alternating episodes of depression and mania, or "highs," characterized by irritability, increased activity, restlessness, impulsive behavior and racing thoughts. Almost 3 percent of U.S. adults have bipolar disorder, the institute says.

In three three-week trials involving more than 1,000 bipolar patients, Vraylar reduced disorder symptoms, the FDA said.

The most common drug-related side effects in the bipolar disorder trial included tremor, slurred speech, an urge to move (akathisia), indigestion, vomiting, drowsiness and restlessness.

All FDA-approved drugs for and bipolar disorder must carry a black box warning indicating an increased risk of death if these drugs are used by older people with dementia-related psychosis, the agency noted.

Explore further: First generic Abilify approved

More information: The U.S. National Institute of Mental Health has more about mental health medications.

Related Stories

First generic Abilify approved

April 30, 2015
(HealthDay)—The first generic versions of the atypical antipsychotic drug Abilify (aripiprazole) have been approved by the U.S. Food and Drug Administration to treat schizophrenia or bipolar disorder.

FDA approves new drug for schizophrenia, major depression

July 13, 2015
(HealthDay)—A new drug to treat schizophrenia and depression has been approved by the U.S. Food and Drug Administration.

How to tell the difference between bipolar disorder and depression

August 5, 2015
Many patients with bipolar disorder, a debilitating mental condition that can take a person from the sluggishness of severe depression to super-human energy levels, are often misdiagnosed as having major depressive disorder, ...

Borderline personality disorder as debilitating as bipolar disorder

April 23, 2015
The deterioration of psychiatric and physical health caused by borderline personality disorder (BPD) rivals that of bipolar disorder, according to Mark Zimmerman, M.D., a researcher at Rhode Island Hospital. His research ...

For women with bipolar disorder, sleep quality affects mood

June 30, 2015
Poor sleep is associated with negative mood in women with bipolar disorder, according to researchers at Penn State College of Medicine and University of Michigan Medical School.

How cannabis use affects people with Bipolar Disorder

March 13, 2015
The first study to examine the use of cannabis in the context of daily life among people with Bipolar Disorder has shown how the drug is linked to increases in both manic and depressive symptoms.

Recommended for you

Study of 800 million tweets finds distinct daily cycles in our thinking patterns

June 20, 2018
Our mode of thinking changes at different times of the day and follows a 24-hour pattern, according to new findings published in PLOS ONE. University of Bristol researchers were able to study our thinking behaviour by analysing ...

Mind wandering is fine in some situations, study says

June 20, 2018
It's a common experience for most students. You're sitting in a lecture that covers material you already know, and before long your mind drifts and you become occupied with thoughts of what you'll do over the weekend, or ...

Around the world, people have surprisingly modest notions of the 'ideal' life

June 20, 2018
It seems reasonable that people would want to maximize various aspects of life if they were given the opportunity to do so, whether it's the pleasure they feel, how intelligent they are, or how much personal freedom they ...

Opioid overdose survivors face continued health challenges, higher death rate

June 20, 2018
Survivors of opioid overdose are at great risk of dying in the year after overdose, but the deaths are not always caused by drug use, a new study reveals. In addition to succumbing to drug use, survivors were much more likely ...

Say cheese! Why a toothy smile makes it easier for you to be identified

June 19, 2018
A fulsome smile in a photo makes it easier for people to identify the individual, say researchers at the University of York.

Mental health declining among disadvantaged American adults

June 19, 2018
American adults of low socioeconomic status report increasing mental distress and worsening well-being, according to a new study by Princeton University and Georgetown University.

1 comment

Adjust slider to filter visible comments by rank

Display comments: newest first

oliverlu70
not rated yet Sep 19, 2015
"Schizophrenia, a chronic and disabling brain disorder..."

The piece should read:

"The schizophrenias, a class of disorders hypothesized to be based in the brain and often (but not always) characterized by chronicity..."

Also how is the new drug better than already-available choices?

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.