The U.S. Food and Drug Administration (FDA) on Thursday approved the first new drug to treat people with schizophrenia in more than 30 years.
Cobenfy, made by Bristol Myers Squibb, combines two medications, xanomeline and trospium chloride, and is taken in pill form twice a day. In clinical trials, this combination helped manage symptoms such as hallucinations, delusions, and disorganized thinking, common in schizophrenia.
“Schizophrenia is one of the leading causes of disability worldwide. “It is a serious, chronic mental illness that often impairs a person’s quality of life,” said Tiffany Farchione, MD, director of the Division of Psychiatry, Office of Neurosciences Center for Assessment and Evaluation. FDA drug research, in approval announcement. .
“This drug represents the first new approach to treating schizophrenia in decades,” Farchione continued. “This approval provides a new alternative to antipsychotic medications previously prescribed to people with schizophrenia.”
Cobenfy offers new hope for people with schizophrenia, offering an innovative treatment option that could change the way this illness is managed, according to Jelena Kunovac, MD, board-certified psychiatrist and adjunct assistant professor at the University of Nevada, Las Vegas , in the Department of Psychiatry.
“We are overdue for a drug targeting schizophrenia with a different mechanism of action,” Kunovac told ABC News.
The first schizophrenia drugs, including chlorpromazine and haloperidol – also known by the brand names Thorazine and Haldol, respectively – were introduced in the 1950s and revolutionized the treatment of the illness. However, very few new drugs have been released since then, with most subsequent FDA approvals going to variants of these older drugs.
Most schizophrenia medications, known as antipsychotics, work by changing levels of dopamine, a brain chemical that affects mood, motivation and thinking, Kunovac explained. Cobenfy takes a different approach by adjusting acetylcholine, another brain chemical that aids memory, learning and attention, she said.
A sign for the Food And Drug Administration is seen outside the headquarters on July 20, 2020 in White Oak, Maryland.
Sarah Silbiger/Getty Images, FILE
By focusing on acetylcholine rather than dopamine, Cobenfy may reduce symptoms of schizophrenia while avoiding common side effects such as weight gain, drowsiness and movement disorders, clinical trials suggest. These side effects often become so severe and unpleasant that, in some studies reflecting real-world challenges, many patients stopped treatment within 18 months of starting it.
In clinical trials, only 6% of patients stopped taking Cobenfy due to side effects, noted Dr. Samit Hirawat, chief medical officer of Bristol Myers Squibb. “This is a significant improvement over the 20 to 30 percent seen with older antipsychotic medications,” he added.
The most common side effects of Cobenfy are nausea, indigestion, constipation, vomiting, high blood pressure, abdominal pain, diarrhea, increased heart rate, dizziness and gastroesophageal reflux disease, according to the FDA announcement.
“It may prove beneficial for those who cannot tolerate what was available,” Dr. Leslie Citrome, a clinical professor of psychiatry and psychopharmacology expert at New York Medical College, told ABC News about Cobenfy. “This will provide a new approach that could work very well.”
Citrome pointed out that patients who have difficulty tolerating the side effects of traditional schizophrenia medications may benefit more from Cobenfy, and that a different mechanism of action offers hope for those who have not responded to this. adequately to existing treatments.
Schizophrenia is a mental health disorder that affects around 24 million people worldwide, or about one in 300 people, according to the World Health Organization (WHO). This often leads to significant challenges in daily functioning, work and relationships, impacting both patients and their families.
This disorder usually appears in late adolescence or early adulthood and can lead to permanent disability if not properly managed, according to the WHO, highlighting the need for treatment options. effective treatment.
After approval, doctors could begin prescribing Cobenfy by the end of October, according to Adam Lenkowsky, executive vice president and chief commercialization officer at Bristol Myers Squibb.
Experts hope the drug’s unique mechanism and reduced side effects will help set a new standard of care for schizophrenia patients. Studies into other therapeutic uses, including the treatment of Alzheimer’s disease and bipolar disorder, are also underway.
Jake Goodman, MD, MBA is a psychiatry resident physician and member of the ABC News Medical Unit.
