In a significant advancement for individuals living with schizophrenia, the FDA has approved a new oral medication for adults. Marketed as Cobenfy, this innovative drug targets a different pathway in the brain compared to traditional antipsychotic medications, offering renewed hope for effective treatment.
Schizophrenia is a severe mental disorder affecting about 1% of the U.S. population and approximately 24 million people globally. It leads to difficulties in distinguishing reality from imagination, with symptoms typically manifesting in late adolescence or early adulthood. The disorder impacts thinking, feeling, and behavior, significantly affecting work, education, relationships, and overall functioning. Individuals with schizophrenia are two to three times more likely to experience early mortality, with around 5% dying by suicide.
“This is the first new treatment approach for schizophrenia in decades, providing an alternative to the standard medications that many patients have relied on,” stated Tiffany Farchione, MD, director of the Division of Psychiatry at the FDA’s Center for Drug Evaluation and Research.
Cobenfy contains the active ingredients xanomeline and trospium chloride, and it aims to alleviate symptoms such as auditory hallucinations, delusions, disorganized speech, lack of motivation, social withdrawal, and cognitive difficulties. Unlike older antipsychotics that primarily target dopamine receptors, Cobenfy focuses on cholinergic receptors, presenting a new option for patients who have not found relief or have experienced severe side effects from conventional treatments.
As reported by webmd, the medication will be available in oral capsule form. Its approval followed a successful phase III clinical trial, with results published in JAMA Psychiatry in May. The study demonstrated that Cobenfy effectively reduced schizophrenia symptoms and was well-tolerated compared to a placebo. Importantly, it did not cause common side effects associated with traditional antipsychotics, such as weight gain, drowsiness, or movement disorders.
Chris Boerner, PhD, CEO of Bristol Myers Squibb, the company behind Cobenfy, views this approval as a significant milestone.
“After more than 30 years, we now have a completely new approach to managing schizophrenia, which could transform treatment strategies,” he remarked.
While Cobenfy does not carry the typical warnings associated with antipsychotic medications, it may cause side effects such as nausea, upset stomach, constipation, diarrhea, stomach pain, high blood pressure, increased heart rate, and dizziness. It may also lead to difficulty emptying the bladder and facial or lip swelling. Patients with liver, kidney, or eye issues, or those with a history of allergic reactions to medications, should consult their healthcare provider before starting treatment.
The effects of Cobenfy on unborn babies or its potential to pass into breast milk are not yet known. Women who are pregnant, planning to become pregnant, or breastfeeding should inform their doctor before initiating treatment.