The US Food and Drug Administration (FDA) has approved Cobenfy (xanomeline and trospium chloride) capsules for oral use in the treatment of schizophrenia in adults. This medication has been developed by the pharmaceutical company Bristol-Myers Squibb and is the first approved antipsychotic that acts on cholinergic receptors instead of dopamine receptors, which have long been the standard of treatment. In fact, it is the first drug that has been approved with a different function than traditional ones in more than 70 years.
“Schizophrenia is one of the main causes of disability worldwide. “It is a serious and chronic mental illness that often negatively affects people’s quality of life,” said Dr. Tiffany Farchione, director of the Division of Psychiatry in the Office of Neuroscience at the Center for Drug Evaluation and Research. the FDA. “This drug represents a novel approach in the treatment of schizophrenia after decades. “Its approval offers a new alternative to the antipsychotics that have been prescribed until now.”
Schizophrenia can cause psychotic symptoms such as hallucinations (hearing voices), difficulty controlling thoughts, and distrust of others. In addition, it is associated with cognitive problems, difficulties in social relationships and lack of motivation. Approximately 24 million people – one in every 300 – suffer from this disease worldwide, according to the World Health Organization (WHO), which considers it one of the 15 main causes of disability. People with schizophrenia have a higher risk of dying at an early age, and almost 5% die by suicide.
Cobenfy significantly reduced schizophrenia symptoms
The effectiveness of Cobenfy in the treatment of schizophrenia in adults was evaluated in two studies with identical design. Both five-week studies were randomized, double-blind, placebo-controlled, and conducted at multiple centers with adults diagnosed with schizophrenia according to DSM-5 criteria.
The primary efficacy measure was the change in Positive and Negative Syndrome Scale (PANSS) total score from baseline to week five. The PANSS is a 30-item scale that measures symptoms of schizophrenia, with each item rated by a clinician on a seven-point scale. In both studies, participants receiving Cobenfy showed a significant reduction in symptoms from baseline to week five, compared to the placebo group.
“This drug represents an important advance in the treatment of schizophrenia and may constitute a good alternative for patients who do not tolerate the drugs currently used”
Eduard Vieta, researcher at the Mental Health Network Biomedical Research Center (CIBERSAM). Head of the Psychiatry and Psychology Service at the Hospital Clínic of Barcelona and professor at the University of Barcelona, stated in statements collected by SMC Spain: “This drug represents an important advance in the treatment of schizophrenia, since it is the first medication that does not It acts directly on dopaminergic receptors, but rather on muscarinic ones. In this sense, although acetylcholine and dopamine are interconnected, it represents a very relevant innovation since it involves a different mechanism of action from current drugs and a profile of adverse effects that is also different, which can constitute a good alternative for patients who do not tolerate drugs. drugs used today.
“In addition, the effect size in the acute phase and the results of the extension study regarding long-term safety and effectiveness are also positive. After its approval, clinical experience will show to what extent it has represented a true advance for clinical practice in this disease so in need of new approaches,” he concludes.
Adverse effects and contraindications of Cobenfy
The prescribing information warns that Cobenfy may cause urinary retention, increased heart rate, decreased gastric movement, or angioedema (swelling under the skin) of the face and lips. Its use is not recommended in patients with mild liver impairment, and it is contraindicated in those with known liver damage, due to the risk of liver injury.
Additionally, patients should stop using Cobenfy if they develop signs of severe liver disease, such as yellowing of the skin or eyes, dark urine, or unexplained itching. Additionally, Cobenfy is largely excreted by the kidneys, so it is not recommended in patients with moderate or severe renal impairment.
This drug should not be prescribed to patients with urinary retention, moderate or severe kidney or liver disease, gastric retention, untreated narrow-angle glaucoma, or a history of hypersensitivity to Cobenfy or its components. The most common side effects of Cobenfy include nausea, indigestion, constipation, vomiting, hypertension, abdominal pain, diarrhea, tachycardia, dizziness, and gastroesophageal reflux.
