FDA Approves New Schizophrenia Drug Mechanism

The U.S. Food and Drug Administration (FDA) has approved Cobenfy (xanomeline and trospium chloride) capsules for the treatment of schizophrenia in adults. This is the first antipsychotic medication targeting cholinergic receptors instead of the traditional dopamine receptors. Tiffany Farchione, M.D., who directs the Division of Psychiatry at the FDA's Center for Drug Evaluation and Research, emphasizes that schizophrenia is a severe, chronic mental illness affecting quality of life and is a leading cause of global disability. The new drug represents the first novel approach to schizophrenia treatment in decades and offers an alternative to current antipsychotic medications.

Schizophrenia is marked by psychotic symptoms such as hallucinations, difficulty in thought control, and suspicion of others. It also involves cognitive problems and social interaction difficulties. Approximately 1% of Americans are affected by schizophrenia, and the condition is listed among the top 15 causes of disability worldwide. Individuals with this illness are at a higher risk of premature death, and about 5% commit suicide.

The efficacy of Cobenfy was tested in two identical studies, labeled Study 1 and Study 2. These were 5-week, randomized, double-blind, placebo-controlled, multi-center trials involving adults diagnosed with schizophrenia as per DSM-5 criteria. The primary measure of efficacy was the change in the Positive and Negative Syndrome Scale (PANSS) total score from baseline to week 5. PANSS is a clinician-rated, 30-item scale that assesses symptoms of schizophrenia on a seven-point scale. Participants receiving Cobenfy exhibited a significant reduction in symptoms by Week 5 compared to those on a placebo.

Cobenfy's prescribing information includes warnings about potential side effects such as urinary retention, increased heart rate, decreased gastric movement, and angioedema, particularly swelling of the face and lips. The medication is not recommended for patients with mild hepatic impairment and is contraindicated for those with known hepatic impairment due to the risk of liver damage. Users should discontinue the drug if they exhibit symptoms of severe liver disease, including jaundice, dark urine, and unexplained itching. Additionally, Cobenfy is mainly excreted through the kidneys and is not advisable for patients with moderate to severe renal impairment.

Patients with 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 should not use the medication. Common side effects reported include nausea, indigestion, constipation, vomiting, hypertension, abdominal pain, diarrhea, tachycardia, dizziness, and gastroesophageal reflux disease.

Bristol-Myers Squibb Company has been granted the approval for Cobenfy.