Cobenfy (xanomeline-trospium chloride) was approved for the treatment of adults with schizophrenia in 2024. Cobenfy is the first medicine approved for the treatment of schizophrenia that works differently than other medicines that are available. Other antipsychotic medicines used to treat schizophrenia balance the amount of dopamine and serotonin in your brain. Cobenfy works by changing the amount of a different chemical called acetylcholine that is in the brain. Cobenfy offers a unique treatment option for schizophrenia with different side effects than these other antipsychotic medicines.
How Does Cobenfy Work, and How Is It Different From Other Medicines Used to Treat Schizophrenia?
An imbalance of brain chemicals called neurotransmitters may contribute to schizophrenia. Current medicines work by attaching to certain receptors in the brain to increase or decrease the amount of these neurotransmitters.
Cobenfy is made up of two ingredients. One of the ingredients in Cobenfy, xanomeline, binds to receptors in the brain that increase the amount of a chemical in the brain called acetylcholine to treat schizophrenia. The second ingredient, trospium, binds to the same receptors in the body that are outside of the brain. This decreases the amount of acetylcholine outside of the brain, which can lower side effects from the medicine. Other medicines that are used to treat schizophrenia bind to receptors that decrease the amount of a different chemical called dopamine. Because Cobenfy works differently than other schizophrenia medicines, it causes different side effects.
How Is Cobenfy Supplied and How Do I Take It?
Cobenfy is an oral capsule that is taken twice daily for schizophrenia.
Cobenfy is available in three strengths of capsules, each of which comes in a different color.
- 50 mg/20 mg: light brownish-yellow color
- 100 mg/20 mg: brown
- 125 mg/30 mg: dark orange
Cobenfy should be taken at least one hour before a meal or two hours after a meal. The capsules should not be opened. You will start by taking a lower dose of Cobenfy for at least two days, and then your dose may be further increased over several days. Your doctor will help you decide which dose of Cobenfy is right for you. Do not stop taking Cobenfy without talking to your health care provider first.
How Was Cobenfy Studied?
Two studies (studies 1 and 2) were completed to see if Cobenfy was safe and effective as a treatment for schizophrenia in adults when compared with a placebo. Placebo-controlled studies help researchers see differences in the benefit or harm of a medicine compared with no treatment.
All of the people in both studies had schizophrenia. Most of the people in the studies were males (75%) and 68% were black, with an average age of 46; about a third of people in the studies were White, and a small percentage (about 1%) were not reported or classified as “other” race. In both studies, Cobenfy was given twice daily at the lowest dose for two days, then increased the dose over the next week or so.
The effectiveness of Cobenfy was measured using a schizophrenia symptom rating scale. A higher score on the scale means more severe symptoms of schizophrenia. A decrease in the scale score shows an improvement in symptoms. This rating scale was measured at the start of the study and after 5 weeks of treatment.
What Benefits Were Seen in the Studies?
At the end of the 5-week study, people who took Cobenfy reduced their schizophrenia symptom scores by about 20 points. This included a benefit on both positive symptoms (delusions and hallucinations) and negative symptoms (lack of emotion, social withdrawal). At the end of the study, people who took Cobenfy had symptom scores about two times lower than people who took an inactive placebo.
Your results may differ from what was seen in clinical studies.
Will I Need Any Monitoring or Blood Tests Before or During Treatment?
People with liver disease should not take Cobenfy. Your health care provider will test your blood before starting Cobenfy and occasionally while you are taking it to make sure that your liver is working well enough to take it.
Cobenfy can also cause your heart rate to be faster. Your health care provider will measure your heart rate before starting Cobenfy and from time to time during treatment.
How Long Does It Take for Cobenfy to Work?
In clinical studies of Cobenfy, most people saw noticeable improvements in their schizophrenia symptoms within 5 weeks. If you have questions about your treatment with Cobenfy, talk to your health care provider.
How Can I Manage Side Effects?
Some people taking Cobenfy may experience urinary hesitancy or retention, where it is difficult to pee or hard to completely empty the bladder. This may increase the risk of urinary tract infection. For less severe symptoms, sitting in a hot bath or setting a timer to remind you to urinate every three hours may help. If you experience urinary retention that is bothersome to you, talk to your health care provider about options to manage it.
Cobenfy can also cause decreased movement of food through your stomach, also called gastroparesis. You can adjust what you eat and how you eat it to help.
Dizziness or sleepiness can also occur with Cobenfy. If you feel dizzy, avoid sudden head movements or getting up quickly from a sitting or lying position. Avoid driving and doing other tasks or actions that require alertness until you know how Cobenfy affects you.
People with liver or kidney problems are more likely to experience these and other side effects.
These are not all of the possible side effects of Cobenfy. Talk with your health care provider if you are having symptoms that bother you. You can also report side effects to the FDA at 800-FDA-1088 (800-332-1088).
How Do the Side Effects From Cobenfy Differ From Other Medicines for Schizophrenia?
Since Cobenfy works differently than other medicines for schizophrenia, it causes different side effects. Urinary retention, slowed stomach emptying, and dizziness or sleepiness are all side effects that are caused by Cobenfy’s effects on acetylcholine in the body.
Other schizophrenia medicines that work by lowering dopamine levels can cause different side effects like weight gain, high blood pressure, diabetes, or high cholesterol. Some can also cause you to develop a type of uncontrolled movements in your body called tardive dyskinesia. Cobenfy does not usually cause these types of side effects. Your health care provider will consider these differences when helping you to decide which medicine is best to treat your schizophrenia.
Is There Any Cost Assistance Available?
There may be cost assistance to help you afford Cobenfy. There is a savings card available from the manufacturer that may allow you to pay as little as $0. You can contact 877-262-3639 or cobenfy.com/support-program for more information.
