In September 2024, the FDA (Food and Drug Administration) approved the use of Cobenfy oral capsules to treat schizophrenia in adults, marking a significant change in the therapeutic approach to the disease.
Unlike traditional antipsychotics, such as Chlorpromazine, which have worked by blocking dopamine receptors since the 1950s, Cobenfy acts on cholinergic receptors, offering an innovative alternative for the treatment of schizophrenia.
Developed by Bristol-Myers Squibb, Cobenfy combines two components: xanomeline, which activates muscarinic receptors in the brain and regulates chemical messengers associated with psychotic symptoms, and trospium chloride, which limits the action of xanomeline outside the brain, thus reducing systemic side effects.
Schizophrenia, a mental disorder that affects thinking, perceptions, emotions, and social interactions, usually appears in adolescence or early adulthood.
Although its development varies from person to person, schizophrenia tends to be a persistent and disabling condition, requiring consistent interventions to manage symptoms such as hallucinations, delusions, and thought disorders.
In many cases, cognitive impairments and unusual behaviors can appear in childhood, progressing over time and being influenced by both genetic and environmental factors, such as prenatal stress.
These characteristics mean that effective treatment depends on approaches that consider the patient's development and the maintenance of emotional and social stability. Treatment of the disease will involve planning by the psychiatrist to monitor the patient and prevent relapses over time.
The acute phase is when the patient is in crisis, with symptoms emerging and in visible mental distress. At this time, some approaches are indicated: The use of antipsychotic medications, these medications act by blocking the neurotransmitters responsible for episodes of delirium and hallucination.
Once the symptoms have disappeared, drug treatment can be used to prevent future outbreaks. Hospitalization, in cases where the patient is in danger to themselves or those around them, hospitalization may be considered. The psychiatrist will assess the need and discuss it with the family.
In the stabilization phase, in addition to medication, the patient must be included in a psychosocial approach program to help them regain social skills and reduce isolation.
To eliminate side effects, it was necessary to develop other medications with other pathways of action. The development of new medications is underway in thousands of laboratories around the world.
However, it is not as simple as it seems. After exhaustive laboratory tests on cells and animals, authorization is granted for testing on humans. Finally, after confirming the efficacy and safety of the medication, the last two go through the authorization process by regulatory agencies that allow the medication to be tested and/or made available to the population. In this case, we are talking about the FDA.
The FDA, an agency within the U.S. Department of Health and Human Services, protects public health by ensuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, and other biological products for human use, and medical devices.
The agency is also responsible for the safety of our nation's food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and the regulation of tobacco products. Its decisions influence the entire world.
Cobenfy was evaluated in two five-week clinical studies involving 470 adults with schizophrenia. Participants who received Cobenfy showed significant improvements compared to the placebo group (sugar pill), with the drug demonstrating control of psychotic symptoms and fewer side effects common to traditional antipsychotics, such as excessive sedation and severe motor symptoms.
The observed adverse effects, such as gastrointestinal problems and changes in blood pressure, were milder, indicating greater tolerability and, possibly, greater adherence to treatment by patients.
The use of typical antipsychotics, which began in the 1950s with the introduction of chlorpromazine, is based on reducing dopamine levels in the brain to alleviate symptoms such as hallucinations and delusions.
Although effective, these treatments often have significant side effects, including weight gain, sedation, and neurological symptoms known as extrapyramidal effects, which often lead patients to discontinue the use of the medication, resulting in relapses.
This reality has led to the search for alternatives with lower risks of adverse effects, especially in a disorder that requires continuous treatment to avoid crises and provide a more stable life.
The approval of Cobenfy represents a milestone in the treatment of schizophrenia and signals a new therapeutic approach after more than seven decades without substantial changes. "Schizophrenia is a leading cause of global disability, impairing the quality of life of those affected," said Dr. Tiffany Farchione, director of the FDA's Division of Psychiatry.
She emphasized that the new medication offers an innovative alternative, opening doors to new treatment possibilities that can improve the quality of life of people with schizophrenia and provide greater adherence and effectiveness in symptom management.
Therefore, Cobenfy represents not only new hope for the treatment of schizophrenia but also exemplifies advances in the development of more effective and safer medications for chronic mental illnesses, enabling interventions that better adjust to the needs of patients and their life contexts.
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