FDA approves groundbreaking drug to treat schizophrenia – KIRO 7 News Seattle

On Thursday, the US Food and Drug Administration (FDA) approved the drug Cobenfy, which works against schizophrenia in a new way.

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

All other available treatments for schizophrenia target the dopamine receptors.

“Schizophrenia is one of the most common causes of disability worldwide. It is a serious, chronic mental illness that often affects a person's quality of life,” said Tiffany Farchione, MD, director of the Division of Psychiatry, Office of Neurosciences in the FDA's Center for Drug Evaluation and Research. “This drug is the first new approach to treating schizophrenia in decades. This approval offers a new alternative to the antipsychotics previously prescribed to people with schizophrenia.”

According to the National Institute of Mental Health, schizophrenia is among the 15 most common causes of disability worldwide.

The most common side effects of Cobenfy are nausea, indigestion, constipation, vomiting, high blood pressure, abdominal pain, diarrhea, tachycardia (increased heart rate), dizziness, and gastroesophageal reflux disease.

The FDA approved Bristol-Myers Squibb Company for Cobenfy.

“Today’s groundbreaking approval of our first-in-class treatment for schizophrenia represents an important milestone for the community, where, after more than 30 years, there is now a completely new pharmacological approach to schizophrenia – one that has the potential to change the treatment paradigm.” said Chris Boerner, PhD, Chairman and Chief Executive Officer at Bristol Myers Squibb. “As we re-enter the field of neuropsychiatry, we want to change the conversation about serious mental illness, starting with today’s approval in schizophrenia.”

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

Patients will be able to enroll in the COBENFY Cares program at the end of October, depending on product availability.

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