The United States Food and Drug Administration (FDA) approved this Thursday the oral use of Cobenfy (xanomeline and trospium chloride) in capsules for the treatment of schizophrenia in adults. It is the first truly novel drug in decades to treat the disease. The product marketed by Bristol Myers Squibb is the first antipsychotic approved for schizophrenia that targets cholinergic receptors rather than blocking dopamine receptors, which have long been the standard of care.
Although Cobenfy has side effects and contraindications, it is expected that it will not generate the complications of current medications, which often cause severe weight gain, cardiac complications and other disabling problems. The new drug also tries to control dopamine levels, but indirectly, through cholinergic receptors, a class of transmembrane proteins that respond to the neurotransmitter acetylcholine, and which are present in various parts of the nervous system.
Schizophrenia can cause psychotic symptoms such as hallucinations (such as hearing voices), difficulty controlling one’s thoughts, and distrust of others. It can also be associated with cognitive problems and difficulties with social interaction and motivation. About 1% of Americans suffer from this disease and, worldwide, it is one of the 15 main causes of disability, according to the FDA. Individuals with schizophrenia have a higher risk of dying at a younger age, and almost 5% die by suicide.
“Schizophrenia is one of the leading causes of disability worldwide. “It is a serious and chronic mental illness that often impairs people’s quality of life,” said Dr. Tiffany Farchione, director of the Division of Psychiatry, Office of Neuroscience, Center for Drug Evaluation and Research at the FDA. , through a statement. “This drug represents the first new approach to the treatment of schizophrenia in decades. “This approval offers a new alternative to antipsychotic medications that have previously been prescribed to people with schizophrenia,” he added.
Efficacy has been demonstrated in only two five-week studies. The primary efficacy measure was the change in the Positive and Negative Syndrome Scale (PANSS) total score at week five, which measures schizophrenia symptoms with 30 parameters. Each is rated on a seven-point scale. In both studies, participants receiving Cobenfy experienced a significant reduction in symptoms from baseline to week five, compared to the placebo group. As these are short-term studies, there is no contrasted data on the effectiveness of the medication in the longer term.
Bristol Myers Squibb has set a price of $1,850 per month for the treatment. The company’s shares have risen sharply on the stock market outside the usual trading hours when the approval of the drug was announced.
Side effects
The prescribing information includes warnings that Cobenfy may cause urinary retention, increased heart rate, decreased gastric movement, or angioedema (swelling under the skin) of the face and lips. Cobenfy is not recommended for patients with mild liver impairment. It should not be used in patients with known hepatic impairment. There is also a risk of liver damage. Patients should stop using it if they experience signs or symptoms of significant liver disease (including yellowing of the skin or whites of the eyes, dark urine, and unexplained itching). Cobenfy is substantially excreted by the kidney and is not recommended in patients with moderate or severe renal impairment.
Cobenfy 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 are nausea, indigestion, constipation, vomiting, hypertension, abdominal pain, diarrhea, tachycardia (increased heartbeat), dizziness, and gastroesophageal reflux disease.
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