Bristol Myers Squibb has received approval from the U.S. Food & Drug Administration for COBENFY, a new oral medication designed to treat schizophrenia in adults. This twice-a-day drug is expected to be available to patients in the United States by mid-October.
COBENFY combines xanomeline and trospium chloride and represents a new class of medicine for schizophrenia. It introduces a different approach by targeting M1 and M4 receptors in the brain without affecting D2 receptors. Clinical trials showed that COBENFY helps manage symptoms such as hallucinations, delusions, and disorganized thinking with fewer side effects compared to older antipsychotic drugs.
Schizophrenia affects an estimated 2.8 million people in the United States. Current medications can be effective but often result in inadequate symptom improvement or intolerable side effects for up to 60% of patients, leading many to discontinue treatment.
Chris Boerner, Ph.D., board chair and CEO at Bristol Myers Squibb, emphasized the significance of this development: “There is now an entirely new pharmacological approach for schizophrenia — one that has the potential to change the treatment paradigm,” he said. “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.”
Symptoms of schizophrenia usually appear in early adulthood and vary among individuals, complicating diagnosis and management. Older drugs used for treatment often cause side effects like weight gain, drowsiness, and movement disorders.
Gordon Lavigne, CEO of the Schizophrenia & Psychosis Action Alliance, stated: “Having a variety of treatment options gives patients and healthcare providers the tools to help manage this serious condition.” He added that FDA's approval “provides a new option as people with schizophrenia move forward with proper support to rebuild their lives.”
Bristol Myers Squibb also announced COBENFY Cares, a program aimed at supporting patients prescribed COBENFY. Enrollment will begin in late October alongside product availability.
