FDA approves first new drug for schizophrenia in decades

Bristol Myers Squibb (BMS) recently received U.S. Food & Drug Administration approval for COBENFY, a new twice-daily oral medication for the treatment of schizophrenia in adults, which is expected to be available to patients in the United States in mid-October.

COBENFY (xanomeline and trospium chloride) represents the first new class of drugs in several decades and introduces a fundamentally new approach to the treatment of schizophrenia by selectively targeting M1 and M4 receptors in the brain without blocking D2 receptors.

In clinical trials, COBENFY helped relieve schizophrenia symptoms such as hallucinations, delusions, and disorganized thinking, with fewer side effects than the older types of antipsychotics used today to treat the disease.

Schizophrenia is a persistent and often disabling mental illness that affects a person's thinking, feeling, and behavior. It is estimated to affect 2.8 million people in the United States. Although existing medications can be effective in treating the symptoms of schizophrenia, up to 60% of people experience inadequate improvement in symptoms or intolerable side effects during therapy, leading many of them to discontinue treatment.

Chris Boerner, Ph.D., chairman and CEO of Bristol Myers Squibb, said the FDA approval is an important milestone. “There is now a completely new pharmacological approach to schizophrenia – one that has the potential to change the treatment paradigm,” said Boerner. “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.”

Schizophrenia symptoms typically first appear in early adulthood and manifest differently in each person, making the symptoms difficult to diagnose and treat. It is often difficult for people with schizophrenia to find treatment that works for them and is well tolerated. Side effects of the older medications prescribed to treat the disease include weight gain, drowsiness, and movement problems.

“A variety of treatment options gives patients and healthcare providers the tools to help them manage this serious condition,” said Gordon Lavigne, CEO of the Schizophrenia & Psychosis Action Alliance. “People with schizophrenia want and deserve more.”

FDA approval of COBENFY “provides a new option as people with schizophrenia receive the right support to rebuild their lives,” Lavigne said.

BMS also 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.

About Bristol Myers Squibb

Long-time NJBIA member Bristol Myers Squibb Is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients overcome serious diseases. For more information, see Here.