FDA approves revolutionary drug for schizophrenia

September 27, 2024 – In a breakthrough for people with schizophrenia, the FDA has approved a new oral medication for adults. Unlike traditional antipsychotics, the drug, marketed under the name Cobenfy, targets a different signaling pathway in the brain, offering new hope for treatment.

Schizophrenia is a serious mental disorder that affects about 1% of people in the United States and about 24 million worldwide. It causes people to have difficulty distinguishing reality from imagination, and symptoms typically appear in late teens or early adulthood. The condition affects how people think, feel and behave, affecting work, education, relationships and general functioning. People with schizophrenia are two to three times more likely to die earlier, with about 5% dying by suicide.

“This is the first new approach to treating schizophrenia in decades and offers an alternative to the standard medications that many patients have previously taken,” said Tiffany Farchione, MD, director of the Division of Psychiatry at the FDA's Center for Drug Evaluation and Research.

Cobenfy does not carry the usual warnings associated with antipsychotics, but some side effects include nausea, stomach upset, constipation, diarrhea, stomach pain, high blood pressure, increased heart rate and dizziness. You may also experience difficulty emptying your bladder and swelling of your face and lips. Patients should consult their doctor if they have liver, kidney, or eye problems or have had an allergic reaction to the medication in the past.

It is not yet known whether 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.