FDA Approves groundbreaking drug for schizophrenia treatment

On Thursday, the U.S. Food and Drug Administration (FDA) approved the drug Cobenfy which targets schizophrenia in a new way.

Cobenfy (xanomeline and trospium chloride) capsules are the first antipsychotic drug approved to target cholinergic receptors.

All other treatments available for schizophrenia target the dopamine receptors.

“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,” said Tiffany Farchione, M.D., director of the Division of Psychiatry, Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research. “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.”

According to the National Institute of Mental Health, schizophrenia is one of the top 15 leading causes of disability worldwide.

The most common side effects of Cobenfy are nausea, indigestion, constipation, vomiting, hypertension, abdominal pain, diarrhea, tachycardia (increased heartbeat), dizziness and gastroesophageal reflux disease.

The FDA granted approval for Cobenfy to the Bristol-Myers Squibb Company.

“Today’s landmark approval of our first-in-class treatment for schizophrenia marks an important milestone for the community, where after more than 30 years, there is now an entirely new pharmacological approach for schizophrenia — one that has the potential to change the treatment paradigm,” said Chris Boerner, PhD, board chair and chief executive officer at Bristol Myers Squibb. “As we reenter the field of neuropsychiatry, we are dedicated to changing the conversation around serious mental illness, beginning with today’s approval in schizophrenia.”

In a press release, Bristol-Myers Squibb announced the launch of COBENFY Cares, a program designed to support patients who have been prescribed COBENFY.

Patients will be able to enroll in the COBENFY Cares program in late October corresponding with product availability.

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