FDA Approves New Schizophrenia Drug in 70-Year First

The U.S. 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 do not respond to existing treatments or suffer from severe side effects.
“People living with schizophrenia have all been essentially treated with a single class of medication for as long as they have been suffering from the disease,” Ken Kramer, who works in medical affairs at drug manufacturer Karuna Therapeutics, a subsidiary of Bristol Myers Squibb, told Nature News in Brief. “Now, here’s a different option. That’s where the greatest level of excitement is from.”
Roughly 1 percent of Americans suffer from schizophrenia, which is one of the 15 leading causes of disability worldwide, the FDA reports. Individuals with this disease have a greater risk of dying young, and nearly 5 percent of those affected take their own lives.
The condition can cause psychotic symptoms, including hallucinations and paranoia. It can also be associated with cognitive problems and difficult with social interactions and motivation.
“[Schizophrenia] is a severe, chronic mental illness that is often damaging to a person’s quality of life,” Tiffany Farchione, M.D., director of the Division of Psychiatry, Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, said in a statement.
Since the 1950s, the only available treatment options have targeted dopamine receptors in the brain, which can help address symptoms of psychosis. However, these drugs are not effective in all patients and can come with substantial side effects, including sedation, weight gain and motor impairment.
However, this newly approved treatment, brand name Cobenfy, targets a new group of receptors called muscarinic acetylcholine receptors. These receptors play an important role in communication across our central nervous system and have shown promise as a therapeutic drug target for a range of neurological diseases, including Alzheimer’s disease, Parkinson’s and schizophrenia.
Cobenfy’s effectiveness in treating schizophrenia in adults was evaluated in two placebo-controlled studies and demonstrated a meaningful reduction in symptoms within just five weeks.
“This drug takes the first new approach to schizophrenia treatment in decades,” Farchione said. “This approval offers a new alternative to the antipsychotic medications people with schizophrenia have previously been prescribed.”
However, the drug is not without its side effects: 15 to 20 percent of trial participants reported nausea and vomiting, and the prescribing information also warns that the drug should not be used by patients with known liver impairments. The same goes for those with urinary or gastric retention or kidney disease.
Even so, the drug offers a promising alternative for the millions of Americans who suffer from this condition.
Bristol Myers Squibb is also testing the drug in other disease-related psychosis, including for patients with Alzheimer’s disease.
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