Bristol Myers Squibb (BMS) recently received U.S. Food & Drug Administration approval for COBENFY, a new twice-a-day oral medication for the treatment of schizophrenia in adults that 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 medicine in several decades and introduces a fundamentally new approach to treating schizophrenia by selectively targeting M 1 and M 4 receptors in the brain without blocking D 2 receptors.
In clinical trials, COBENFY helped manage schizophrenia symptoms such as hallucinations, delusions, and disorganized thinking, with fewer side effects than the older types of antipsychotic drugs that are now used to treat the disease.
Schizophrenia is a persistent and often disabling mental illness affecting how a person thinks, feels and behaves. It is estimated to impact 2.8 million people in the United States. Although existing medications can be effective in managing symptoms of schizophrenia, up to 60% of people experience inadequate improvement in symptoms or intolerable side effects during therapy that causes many of them to discontinue their treatment.
Chris Boerner, Ph.D., board chair and CEO at Bristol Myers Squibb, said the FDA approval marks an important milestone. “There is now an entirely new pharmacological approach for schizophrenia — one that has the potential to change the treatment paradigm,” Boerner 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.”
Schizophrenia symptoms typically first appear in early adulthood and present differently in each person, making symptoms difficult to diagnose and manage. For people living with schizophrenia, it is often difficult to find a treatment that works for them and is well-tolerated. Side effects of the older drugs prescribed to treat the disease include weight gain, drowsiness, and movement disorders.
“Having a variety of treatment options gives patients and healthcare providers the tools to help manage this serious condition,” said Gordon Lavigne, CEO of the Schizophrenia & Psychosis Action Alliance. “People living with schizophrenia want and deserve more.”
The FDA approval of COBENFY “provides a new option as people with schizophrenia move forward with proper support to rebuild their lives,” Lavigne said.
BMS also announced the launch of COBENFY Cares, a program designed to support patients prescribed COBENFY. Patients can enroll in the COBENFY Cares program in late October, corresponding with product availability.
About Bristol Myers Squibb
Longtime NJBIA member Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information, go here.
