Sept. 27, 2024 – In a breakthrough for people living with schizophrenia, the FDA has approved a new oral medication for adults. Unlike traditional antipsychotic drugs, the medication, which will be marketed under the name Cobenfy, targets a different pathway in the brain, offering new hope for treatment.
Schizophrenia is a serious mental disorder that affects about 1% of people in the U.S. and around 24 million worldwide. It causes people to struggle with distinguishing reality from imagination, and symptoms typically appear in the late teens or early adulthood. The condition affects how people think, feel, and behave, impacting work, education, relationships, and overall functioning. People with schizophrenia are 2 to 3 times more likely to die younger, with about 5% dying by suicide.
"This is the first new approach to schizophrenia treatment in decades, offering an alternative to the standard medications that many patients have used," said Tiffany Farchione, MD, director of the Division of Psychiatry at the FDA’s Center for Drug Evaluation and Research.
The active ingredients in Cobenfy are xanomeline and trospium chloride. The drug is designed to help reduce symptoms such as hearing voices, delusions, disorganized speech, lack of motivation, social withdrawal, and difficulty with thinking, memory, and decision-making. Unlike older drugs, which target dopamine receptors, Cobenfy works on cholinergic receptors, providing a new option for people who haven't found relief or who had harsh side effects from other treatments.
Cobenfy will be available in oral capsules. Its approval was based on a successful phase III clinical trial whose results were published in JAMA Psychiatry in May. The study showed that Cobenfy eased schizophrenia symptoms and was well-tolerated, compared to a placebo. Notably, it didn’t cause common side effects like weight gain, drowsiness, or movement disorders, which are often linked to traditional treatments.
Chris Boerner, PhD, the CEO of Bristol Myers Squibb, the company behind Cobenfy, sees this approval as a significant milestone.
"After more than 30 years, there’s now a completely new approach to treating schizophrenia that could change the way the condition is managed,” he said.
Cobenfy doesn’t carry the usual warnings that come with antipsychotic drugs, but some side effects include nausea, upset stomach, constipation, diarrhea, stomach pain, high blood pressure, increased heart rate, and dizziness. It may also make it hard to empty your bladder and cause swelling of the face and lips. Patients should consult their doctor if they have liver, kidney, or eye problems or a history of allergic reactions to the medication.
It’s not yet known if Cobenfy can harm an unborn baby or pass into breast milk. Women who are pregnant, planning to become pregnant, or breastfeeding should inform their doctor before starting treatment.
