The FNIH Applauds FDA Approval of Novel Treatment for Schizophrenia

The Foundation for the National Institutes of Health (FNIH) welcomes the FDA’s approval of Cobenfy, an oral medication that marks the first new approach in decades to the treatment of schizophrenia, a chronic, severe mental illness.

Cobenfy (xanomeline and trospium chloride) targets a different area of the brain than traditional antipsychotic agents to relieve symptoms like delusions without causing side effects such as weight gain and involuntary muscle jerking, which can lead people to stop taking the older drugs. While these older treatments can be effective in managing symptoms, 30-60% of people using them do not see sufficient symptom improvement or experience intolerable side effects. Cobenfy combines an agent called xanomeline, used to control symptoms, with trospium to block unwanted side effects.

“It’s exciting to see such a novel approach to a complex medical problem,” said Julie Gerberding, MD, MPH, the President and CEO of the FNIH. “This achievement is the culmination of years of research and development by dedicated biomedical professionals, including Steve Paul, MD, Board Chair of the FNIH. His leadership and dedication to improving the lives of people affected by this disorder were instrumental in developing this drug.”

Dr. Paul is the former CEO as well as head of research and development and chief scientific officer at Karuna Therapeutics, which developed Cobenfy. (Bristol Myers Squib, which will market the drug, acquired Karuna Therapeutics last year.)

“Through ongoing work with its partners, the FNIH remains committed to improving treatments for patients by identifying early indicators of schizophrenia,” Dr. Gerberding added.

The FNIH-managed Accelerating Medicines Partnership® (AMP®) Program Schizophrenia (AMP SCZ) is a major public-private partnership between National Institutes of Health’s National Institute of Mental Health (NIMH) and private partner organizations from the industry and nonprofit sectors that addresses the critical need for more effective treatments for individuals with schizophrenia and related mental health conditions.

AMP SCZ aims to develop tools to define early risk stages better and predict the likelihood of progression to psychosis and other undesired outcomes such as anxiety, depression, and substance use disorders. Such tools will help identify novel drug targets and enable clinical trials to test new pharmacologic interventions that may prevent or delay the onset of psychosis in at-risk patients.

About Schizophrenia
Schizophrenia is a mental disorder that can cause psychotic symptoms, including hallucinations, difficulty controlling one’s thoughts, and being suspicious of others. It also is linked to cognitive problems and difficulty with motivation and social interactions. Schizophrenia is one of the top 15 leading causes of disability worldwide. People with schizophrenia are at increased risk of dying at a younger age; nearly 5% die by suicide.

About the Accelerating Medicines Partnership
Launched in 2014 and managed by the FNIH, the Accelerating Medicines Partnership® (AMP®) program brings together the National Institutes of Health, U.S. Food and Drug Administration, biomedical and life science companies, nonprofits, patient-focused groups, and other organizations to transform the current model for developing new diagnostics and treatments. Using cutting-edge scientific approaches and broad sharing of research data, all AMPs seek to improve understanding of disease pathways, facilitate better selection of targets for drug development, and streamline processes for bringing new treatments to patients. To learn more about AMP, visit fnih.org/AMP.