FDA Approves Schizophrenia Drug Cobenfy, the First in Decades

The U.S. Food and Drug Administration (FDA) has approved a schizophrenia drug which is the first updated treatment for the illness in several decades.

The approval was announced Thursday regarding the Bristol Myers Squibb drug known as Cobenfy, CNBC reported.

“Bristol Myers Squibb expects the twice-daily pill, which will be sold under the brand name Cobenfy, to be available in late October, executives told CNBC. The drug is a badly needed new option for the nearly 3 million adults in the U.S. living with schizophrenia, some medical experts say,” the article read.

According to the FDA’s press release, the medicine which is in capsule form for oral use “targets cholinergic receptors as opposed to dopamine receptors, which has long been the standard of care.”
Tiffany Farchione, M.D., who is the director of the Division of Psychiatry, Office of Neuroscience in the agency’s Center for Drug Evaluation and Research, said schizophrenia is a severe and chronic mental illness that can damage an individual’s quality of life.

“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,” she said.

In 2016, scientists said they found genetic connections that may influence the onset of the mental illness, which has been considered to be genetic for quite some time, UPI reported.

The FDA press release offered more details about the drug:

Cobenfy’s effectiveness for the treatment of schizophrenia in adults was evaluated in two studies with identical designs. Study 1 and Study 2 were 5-week, randomized, double-blind, placebo-controlled, multi-center studies in adults with a diagnosis of schizophrenia according to DSM-5 criteria. The primary efficacy measure was the change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score at week 5. The PANSS is a 30-item scale that measures symptoms of schizophrenia. Each item is rated by a clinician on a seven-point scale. In both studies, the participants who received Cobenfy experienced a meaningful reduction in symptoms from baseline to Week 5 as measured by the PANSS Total Score compared to the placebo group.

Schizophrenia can cause people to experience hallucinations, delusions, disorganized thinking and behavior, according to the Mayo Clinic.

“People with schizophrenia need lifelong treatment. This includes medicine, talk therapy and help in learning how to manage daily life activities,” the clinic’s website read.