<--GAT-->

FDA Approves Option for Schizophrenia, Bipolar Treatment

by U.S. Medicine

October 11, 2015

JERSEY CITY, NJ – A new option for treating schizophrenia and bipolar disorder in adults has been approved by the Food and Drug Administration.

The drug Vraylar, cariprazine in capsule form, is manufactured by Forest Laboratories LLC of Jersey City, NJ, and distributed by Actavis Pharma Inc. of Parsippany, NJ.

“Schizophrenia and bipolar disorder can be disabling and can greatly interfere with day-to-day activities,” said Mitchell Mathis, MD, director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “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.”

In each of three six-week clinical trials involving 1,754 participants, Vraylar was shown to reduce the symptoms of schizophrenia compared to placebo, according to the FDA. In addition, the drug’s effectiveness in treating bipolar disorder was shown in a trio of three-week clinical trials of 1,037 participants.

The FDA notes that Vraylar and all other FDA-approved drugs used to treat schizophrenia and bipolar disorder have a Boxed Warning alerting health care professionals about an increased risk of death associated with the use of these drugs in older people with dementia-related psychosis, adding that neither Vraylar nor any other drug in this class is approved to treat such patients.


Comments are closed here.


Related Articles

Bergendahl Uses Video Gaming to Help Fellow Veterans Recover

Mat Bergendahl, MS, LPC, was with the Air Force Security Forces when the United States invaded Iraq in 2003. Like many servicemembers, he managed to bring along some personal effects. And, like many people his... View Article

Pharmacist Involvement Improves Accuracy of Direct Oral Anticoagulants

PALO ALTO, CA—For decades, patients prescribed warfarin to reduce the risk of stroke following a diagnosis of atrial fibrillation have made regular visits to pharmacist- or nurse-directed clinics to ensure their international normalized ratio (INR)... View Article


U.S. Medicine Recommends


More From fda news

FDA News

VA Study Addresses Concerns About Anti-Epileptic Drugs, Suicidal Behavior Link

In 2008, the U.S. Food and Drug Administration issued an alert about increased risk for suicidal ideation and behavior for patients taking anti-epileptic drugs (AEDs).

FDA News

Long-Acting Insulins Approved by FDA

PLAINSBORO, NJ – Physicians treating diabetes patients have new weapons in their arsenal.The Food and Drug Administration recently approved Tresiba (insulin degludec injection) and Ryzodeg 70/30 (insulin degludec/insulin aspart injection) to improve glucose control in... View Article

FDA News

New DHA Screening Process Brings Drug Compounding Costs to 2% of April Levels

DHA Pharmacy Chief Says “Nefarious Actors” Targeted BeneficiariesBy Annette M. BoyleWASHINGTON — In April, the Defense Health Agency (DHA) spent $18 million a day in compound drug claims. By July, the daily costs had dropped... View Article

FDA News

FDA Approves Tecfidera for Treatment of Relapsing MS

WESTON, MA – The U.S. Food and Drug Administration has approved Tecfidera (dimethyl fumarate) capsules to treat adults with relapsing forms of multiple sclerosis (MS). “No drug provides a cure for multiple sclerosis, so it... View Article

FDA News

Stivarga Approved for Some Stromal Tumors After Use of First-Line Therapies

WAYNE, NJ – Tthe U.S. Food and Drug Administration (FDA) has approved Bayer’s Stivarga (regorafenib) tablets to treat patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with... View Article

Subscribe to U.S. Medicine Print Magazine

U.S. Medicine is mailed free each month to physicians, pharmacists, nurse practitioners, physician assistants and administrators working for Veterans Affairs, Department of Defense and U.S. Public Health Service.

Subscribe Now

Receive Our Email Newsletter

Stay informed about federal medical news, clinical updates and reports on government topics for the federal healthcare professional.

Sign Up