Sep 30, 2024 14:00:00

FDA approves first new schizophrenia drug in decades

On September 26, 2024, the U.S. Food and Drug Administration (FDA) approved Cobenfy capsules, which contain

xanomeline and trospium chloride, for the treatment of schizophrenia in adults. This is the first time in decades that a new drug has been approved to treat schizophrenia since chlorpromazine and haloperidol were introduced in the 1950s.

FDA Approves Drug with New Mechanism of Action for Treatment of Schizophrenia | FDA
https://www.fda.gov/news-events/press-announcements/fda-approves-drug-new-mechanism-action-treatment-schizophrenia

FDA approves 1st new drug for schizophrenia in more than 30 years - ABC News

https://abcnews.go.com/Health/fda-approves-1st-new-drug-schizophrenia-30-years/story?id=114070951

The history of schizophrenia treatment dates back to the discovery of chlorpromazine and haloperidol in the 1950s. These drugs, known as Thorazine or Haldol, were prescribed to patients as antipsychotics . These drugs revolutionized the treatment of schizophrenia, but few new drugs have been discovered since then, and most FDA approvals since then have been new variations of drugs using chlorpromazine and haloperidol.

However, on September 26, 2024, the FDA approved Covenfi, developed by Bristol-Myers Squibb, as a new drug. Covenfi is a tablet that combines two drugs, xanomeline and trospium chloride, and is said to be able to suppress symptoms such as hallucinations, delusions, and disorganized thinking that are common in schizophrenia patients by taking it twice a day.

What sets Covenfy apart from previous schizophrenia medications is that while previous schizophrenia medications alter levels of dopamine , a brain chemical that affects mood, motivation and thinking, Covenfy modulates acetylcholine , another brain chemical that enhances memory, learning and attention.

By focusing on acetylcholine, Covenfy has shown the potential to reduce schizophrenia symptoms while avoiding common side effects of conventional medications, such as weight gain, drowsiness, and movement disorders. Side effects such as weight gain can be unpleasant for patients, and previous studies have shown that 20-30% of patients ask to discontinue treatment within 18 months of starting treatment. However, only 6% of patients discontinued Covenfy due to side effects.

'Covenfi offers the first new approach to treating schizophrenia in decades,' said FDA Commissioner Tiffany Furchione, M.D. 'Today's approval creates new alternatives for prescribing medications for people with schizophrenia.'

Dr. Leslie Citrom of New York Medical College added, 'Patients who cannot tolerate the side effects of current schizophrenia medications may benefit most from Covenfy. We also hope that even patients who have not responded adequately to existing treatments may find that taking Covenfy offers hope of symptom relief.'

'Beginning in October 2024, physicians will be able to begin prescribing Covenfi,' said Adam Lenkovsky, executive vice president of Bristol-Myers Squibb.