FDA Approves First New Schizophrenia Drug In 30 Years: Cobenfy Offers Hope With Fewer Side Effects | Details

For the first time in nearly three decades, a new treatment for schizophrenia has been approved by the U.S. Food and Drug Administration (FDA). On September 26, the FDA gave the green light to Cobenfy, a drug developed by Karuna Therapeutics, which was later acquired by Bristol Myers Squibb. Cobenfy represents the first new class of treatment for the disorder since the approval of clozapine, an atypical antipsychotic, in 1989.

Unlike existing schizophrenia medications, Cobenfy operates through a novel mechanism, sparking excitement and hope among both doctors and patients. The drug combines xanomeline, a muscarinic agonist, and trospium, which together regulate brain pathways to reduce dopamine levels and alleviate schizophrenia symptoms.

Until now, all available antipsychotics have worked by blocking dopamine receptors, which helps most schizophrenia patients manage symptoms like hallucinations and paranoia. However, these medications come with significant drawbacks, such as weight gain, which contributes to high rates of heart disease and premature death in people with schizophrenia. Additionally, many patients stop using them due to side effects like sluggishness and lack of motivation.

The newly approved drug, Cobenfy, also affects dopamine levels, but indirectly, by altering the levels of another neurotransmitter—acetylcholine. Researchers are hopeful that this new approach will address some of the most challenging symptoms of the disorder, such as lack of motivation and inability to experience pleasure.

The FDA has approved Cobenfy as a monotherapy, meaning it is intended to be taken on its own, without other medications. However, further research is needed to understand how it interacts with existing treatments and whether combining it with them would offer any additional benefits or risks.

Unlike traditional dopamine-based therapies, the side effects of Cobenfy reported in trials were mostly mild to moderate, such as nausea and gastrointestinal discomfort, which tended to subside over time. There are also warnings related to urinary retention, increased heart rate, and facial swelling in rare cases. The medication is not recommended for people with a history of liver or kidney disorders.

Bristol Myers Squibb is continuing to investigate Cobenfy’s long-term effects and how dosage adjustments can be made as patients' symptoms change. The drug's success in treating schizophrenia may open doors to its use in other conditions as well.

Bristol Myers Squibb (BMS) expects Cobenfy to be available in the U.S. by late October. In terms of cost, Bristol Myers Squibb estimates the wholesale price for a month’s supply of Cobenfy will be $1,850. However, the actual cost for patients may be lower depending on their insurance coverage. The company estimates that 80% of people with schizophrenia in the U.S. have coverage through Medicare or Medicaid, potentially making the treatment more accessible to a broader range of patients.