FDA Approves First New Schizophrenia Drug in Years

The U.S. Food and Drug Administration (FDA) announced late Thursday that it had approved Bristol Myers’ new schizophrenia drug. Regulators signed off on Cobenfy (xanomeline and trospium chloride) for adults.

According to the agency, Bristol Myers Squibb’s drug is “the first antipsychotic drug approved to treat schizophrenia that targets cholinergic receptors as opposed to dopamine receptors.” It’s also the first new pharmaceutical treatment for schizophrenia patients to earn regulatory approval in several decades.

“Today’s approval is a significant milestone for the schizophrenia community,” Bristol Myers Squibb CEO Chris Boerner, PhD, said in a press release. “For the first time in more than 30 years, we have a new pharmacological approach with the potential to change the treatment landscape.”

New Treatment for an Old Problem

Roughly 2.8 million Americans – 1 percent of the population – struggle with schizophrenia. And existing treatments still fail to control most symptoms, or incur life-altering side effects, which has driven the race for new options.

“Schizophrenia is a leading cause of disability worldwide. It is a severe, chronic mental illness that is often damaging to a person’s quality of life,” Tiffany Farchione, MD, director of the Division of Psychiatry, Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, said. “This drug takes the first new approach to schizophrenia treatment in decades. This approval offers a new alternative to the antipsychotic medications people with schizophrenia have previously been prescribed.”

As Farchione mentioned, schizophrenia remains one of the world’s 15 leading causes of disability. Worse still, schizophrenia patients are at greater risk of dying younger. And almost 5 percent of them take their own lives.

“This provides a new option that could help patients manage this serious condition with greater success,” Schizophrenia & Psychosis Action Alliance CEO Gordon Lavigne said in a press release. “People living with schizophrenia want and deserve more. Today’s approval provides a new option as people with schizophrenia move forward with proper support to rebuild their lives.”

Parsing the Fine Print

The FDA gave Cobenfy the nod based on a pair of identically designed studies. The studies were five-week, randomized, double-blind, placebo-controlled, multi-center studies in diagnosed adults. 

The primary efficacy measure, according to regulators, “was the change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score at week five.” In both studies, the participants who received Cobenfy experienced a notable drop in symptoms from baseline to week five as measured by the PANSS Total Score, compared to the placebo group.

Cobenfy’s most commonly reported side effects include nausea, indigestion, constipation, vomiting, hypertension, abdominal pain, diarrhea, tachycardia (increased heartbeat), dizziness, and gastroesophageal reflux disease.

The FDA added in its approval statement that caregivers should not prescribe the drug to patients with liver impairment.

Further Reading

Transient Cola Use Disorder in a Patient With Schizophrenia

Breaking Down Emerging Research on Catatonia in Schizophrenia

Cognition in Schizophrenia