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People with schizophrenia will have a new treatment option for the first time in more than three decades, after the Food and Drug Administration Thursday approved a new kind of drug.
Studies showed Bristol Myers Squibb’s drug, KarXT, improved symptoms of schizophrenia and led to fewer side effects than existing antipsychotic treatments. Researchers are optimistic patients might stick with this medication longer than existing drugs, which patients often quit due to side effects.
KarXT is a twice-daily oral medication for adults that combines two drugs: Xanomeline, which targets muscarinic receptors in the brain, and trospium, which alleviates digestive and other symptoms that result from this type of medication. The promising drug combination was discovered and tested by Karuna Therapeutics, which Bristol Myers Squibb acquired in March.
Bristol Myers Squibb will sell the drug combination under the brand name Cobenfy. The pharmaceutical company hasn’t said how much it will charge for the medication.
The nonprofit Institute for Clinical and Economic Review, which analyzes drug prices, said in January that the drug would be cost effective if priced between $16,000 and $20,000 per year.
In April, Bristol Myers Squibb released the results of a study that found three-quarters of patients saw their symptoms improve by 30% or more after one year on KarXT.
The KarXT approval comes after decades of no significant treatment advancements for schizophrenia patients. About 3.7 million, or 1.8%, of adults in the U.S. have a lifetime history of schizophrenia, according to research published in 2023. The estimate was two to three times higher than previous estimates.
Doctors are hopeful KarXT will make a meaningful difference for patients who’ve struggled with existing antipsychotic medications, said Jelena Kunovac, a clinical assistant professor at University of Nevada, Las Vegas.
She said 75% of patients discontinue antipsychotics within 18 months, often due to stigma or side effects of existing drugs. Antipsychotics can cause weight gain, drowsiness, metabolic syndrome, which can increase risk of heart attack or stroke, or involuntary movements such as blinking or sticking out your tongue.
“The field is ready to try something different,” Kunovac said. “This medication may be a game changer for some subset of patients.”
Schizophrenia can cause people to hallucinate, struggle to control thoughts or become suspicious of others.
Researchers have tried without success to develop new class of schizophrenia medications since the last wave of dopamine-blocking antipsychotics emerged in the 1990s.
Earlier this week, a study in the journal “Psychiatric Services in Advance” found that 70% of adults with schizophrenia had some type of mental health treatment in the past year. Only 30% were currently taking an antipsychotic.
