The U.S. Food and Drug Administration (FDA) has approved Cobenfy, a groundbreaking new drug for schizophrenia that promises to revolutionize treatment with its novel mechanism, the first of its kind in decades.
Schizophrenia is a serious and disabling mental health condition that affects the way a person thinks, feels, and behaves. About 1% of Americans are affected by schizophrenia, making it one of the 15 leading causes of disability worldwide.
Unlike previous schizophrenia treatments that primarily targeted dopamine receptors, Cobenfy, manufactured by Bristol Myers Squibb and formerly known as KarXT, introduces a novel approach by focusing on cholinergic receptors.
Cholinergic receptors are proteins in cell membranes that respond to the neurotransmitter acetylcholine. They are essential for nerve signaling and affect key functions like memory, cognition, and synaptic plasticity, as well as regulating automatic functions in different organs.
"Schizophrenia is a leading cause of disability worldwide. It is a severe, chronic mental illness that is often damaging to a person's quality of life. This drug takes the first new approach to schizophrenia treatment in decades. This approval offers a new alternative to the antipsychotic medications people with schizophrenia have previously been prescribed," said Dr. Tiffany Farchione from the FDA's Center for Drug Evaluation and Research in a news release.
The results from the manufacturer's trials announced in April showed that over 75% of participants had more than a 30% improvement in their symptoms, with an average reduction of 33.3 points from baseline.
"Today's landmark approval of our first-in-class treatment for schizophrenia marks an important milestone for the community, where after more than 30 years, there is now an entirely new pharmacological approach for schizophrenia — one that has the potential to change the treatment paradigm. 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," said Chris Boerner, board chair and chief executive officer at Bristol Myers Squibb in a news release.
While weight gain is a common side effect of many antipsychotic drugs, the EMERGENT trials that evaluated the safety and efficacy of KarXT showed that approximately 65% of participants lost weight, with a mean decrease of 2.6 kg over a year.
The most common adverse reactions to the drug include nausea, dyspepsia, constipation, vomiting, hypertension, abdominal pain, diarrhea, tachycardia, dizziness, and gastroesophageal reflux disease.
Those individuals who have issues such as urinary retention, moderate or severe kidney or liver disease, gastric retention, untreated narrow-angle glaucoma, or a history of hypersensitivity to either Cobenfy or its components are advised not to take the medication.
