HQ Team
27 September, 2024: The U.S. Food and Drug Administration (FDA) has approved Cobenfy (xanomeline and trospium chloride) for the treatment of schizophrenia in adults. This medication was developed by Karuna Therapeutics, now a part of Bristol Meyers.
New approach to treatment
The approval of Cobenfy is a breakthrough approval after almost 70 years and appears to avoid side effects that cause many patients to stop taking their medication.
Cobenfy is the first antipsychotic drug that targets cholinergic receptors rather than the traditional dopamine receptors, which have been the standard target for decades. According to Dr. Tiffany Farchione, director of the Division of Psychiatry at the FDA, this approval represents a vital alternative for individuals suffering from schizophrenia, a disorder that affects about 1% of the U.S. population and significantly impacts their quality of life.
Understanding schizophrenia
Schizophrenia is characterized by symptoms such as hallucinations, disorganized thinking, and emotional flatness. It can lead to severe cognitive challenges and social withdrawal. The condition is one of the leading causes of disability worldwide, and individuals with schizophrenia often face increased risks, including premature death and suicide.
Clinical trials
The efficacy of Cobenfy was evaluated in two randomized, double-blind, placebo-controlled studies involving adults diagnosed with schizophrenia. Over five weeks, participants receiving Cobenfy demonstrated a significant reduction in symptoms compared to those on placebo, as measured by the Positive and Negative Syndrome Scale (PANSS).
Dr Lynsey Bilsland, Head of Mental Health Translation, Wellcome, said: “Schizophrenia is commonly treated with antipsychotics. While these can be effective in managing symptoms like hallucinations and delusions, they do not address other life-limiting symptoms such as social withdrawal and memory problems. Cobenfy has the potential to address all of the above symptoms and also has fewer side effects such as sleepiness and weight gain and therefore could be game-changing, especially for those for whom other drugs do not work.
Safety considerations
While Cobenfy offers new hope, it also comes with important safety warnings. Potential side effects include urinary retention, increased heart rate, and gastrointestinal issues such as nausea and constipation. It is not recommended for patients with certain liver or kidney conditions or those who have experienced hypersensitivity to its components.
Looking Ahead
Cobenfy, set to launch in October, will have a list price that would cost about $22,500 a year.
The approval of Cobenfy is expected to provide new treatment options for patients struggling with schizophrenia, a disease that afflicts about 24 million people globally.
