September 27, 2024 – In a breakthrough for individuals with schizophrenia, the FDA has approved a brand new oral medication for adults. Unlike traditional antipsychotics, the drug, marketed under the name Cobenfy, targets a special signaling pathway within the brain, offering recent hope for treatment.
Schizophrenia is a serious mental disorder that affects about 1% of individuals within 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 maturity. The condition affects how people think, feel and behave, affecting work, education, relationships and general functioning. People with schizophrenia are two to 3 times more 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 on the FDA's Center for Drug Evaluation and Research.
The energetic ingredients in Cobenfy are xanomeline and trospium chloride. The medication is meant to assist relieve symptoms resembling hearing voices, delusions, disorganized speech, lack of motivation, social withdrawal, and difficulty with considering, memory, and decision-making. Unlike older medications that focus on dopamine receptors, Cobenfy acts on cholinergic receptors, offering a brand new option for individuals who don't experience relief or who’ve had severe unintended effects from other treatments.
Cobenfy will likely be available in oral capsules. The approval was based on a successful phase III clinical trial, the outcomes of which were published in JAMA Psychiatry in May. The study showed that Cobenfy relieved symptoms of schizophrenia and was well tolerated in comparison with a placebo. Notably, it didn’t cause common unintended effects resembling weight gain, drowsiness, or movement problems which can be often related to traditional treatments.
Chris Boerner, PhD, CEO of Bristol Myers Squibb, the corporate behind Cobenfy, sees this approval as a big milestone.
“After more than 30 years, there is now a completely new approach to treating schizophrenia that could change the way the disease is managed,” he said.
Cobenfy doesn’t carry the standard warnings related to antipsychotics, but some unintended effects include nausea, stomach upset, constipation, diarrhea, stomach pain, hypertension, increased heart rate and dizziness. You can also experience difficulty emptying your bladder and swelling of your face and lips. Patients should seek the advice of their doctor in the event that they have liver, kidney, or eye problems or have had an allergic response to the medication previously.
It isn’t yet known whether Cobenfy can harm an unborn baby or pass into breast milk. Women who’re pregnant, planning to develop into pregnant or breastfeeding should inform their doctor before starting treatment.