FDA approves new drug for schizophrenia for first time in 70 years

The US Food and Drug Administration has approved a new drug for schizophrenia with a new mechanism of action for the first time in over 70 years. The treatment offers hope to thousands of patients who are not responding to existing treatments or are suffering serious side effects.

“People living with schizophrenia are essentially all treated with a single class of drugs for as long as they have the disease,” says Ken Kramer, who works in the medical field at drugmaker Karuna Therapeutics, a subsidiary of Bristol Myers Squibb. told Nature news coming soon. “There is another option here. That’s where the excitement is greatest.”

About 1 percent of Americans suffer from schizophrenia, which is one of the 15 most common causes of disability worldwide, according to the FDA. People with the disease have a higher risk of dying young, and nearly 5 percent of those affected take their own lives.

The disorder can cause psychotic symptoms such as hallucinations and paranoia. It can also be associated with cognitive problems and difficulties with social interactions and motivation.

“[Schizophrenia] is a serious, chronic mental illness that often affects a person's quality of life,” said Tiffany Farchione, MD, director of the Division of Psychiatry, Office of Neurosciences in the FDA's Center for Drug Evaluation and Research, in a statement.

Since the 1950s, the only treatment options available target dopamine receptors in the brain and can help relieve the symptoms of psychosis. However, these medications are not effective in all patients and can cause significant side effects such as sedation, weight gain, and motor impairment.

However, this newly approved treatment, branded Cobenfy, targets a new group of receptors called muscarinic acetylcholine receptors. These receptors play an important role in communication in our central nervous system and have shown promise as a therapeutic target for drugs in a number of neurological diseases, including Alzheimer's, Parkinson's and schizophrenia.

The effectiveness of Cobenfy in treating schizophrenia in adults was evaluated in two placebo-controlled trials and showed a significant reduction in symptoms in just five weeks.

“This drug represents the first new approach to treating schizophrenia in decades,” Farchione said. “This approval offers a new alternative to the antipsychotics previously prescribed to people with schizophrenia.”

However, the drug is not without side effects: 15 to 20 percent of study participants reported nausea and vomiting, and the product information also warns against taking the drug in patients with known liver dysfunction. The same applies to people with urinary or stomach retention or kidney disease.

Still, the drug offers a promising alternative for the millions of Americans suffering from the disease.

Bristol Myers Squibb is also testing the drug in other disease-related psychoses, including patients with Alzheimer's disease.

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