What is the name of the drug and what does it do?
Cobenfy (pronounced co-BEN-fee), generic name xanomeline and trospium chloride, is a prescription medication approved on September 26, 2024 to treat schizophrenia in adults. Schizophrenia is a mental health condition that affects how a person thinks, feels, and behaves, often causing hallucinations, delusions, and difficulty thinking clearly.
How does it work?
Cobenfy contains two active ingredients with different roles. Xanomeline is a muscarinic agonist, meaning it stimulates certain receptors in the brain that help regulate mood and thought processes. Trospium chloride is a muscarinic antagonist, which helps block certain unwanted side effects of xanomeline, such as excessive stimulation in the body’s peripheral systems. Together, they work to improve symptoms of schizophrenia while minimizing side effects.
What did the research discover?
Cobenfy was studied in two clinical trials with over 470 adults diagnosed with schizophrenia. Patients treated with Cobenfy showed significant improvements in their Positive and Negative Syndrome Scale (PANSS) scores, which measure the severity of schizophrenia symptoms. After five weeks of treatment, patients taking Cobenfy experienced a greater reduction in symptom severity compared to those who received a placebo. These results demonstrate Cobenfy’s ability to improve thinking, behavior, and emotional symptoms in people with schizophrenia.
What are some of the side effects?
The most common side effects of Cobenfy include:
- Nausea
- Constipation
- Vomiting
- High blood pressure
- Stomach pain
- Diarrhea
- Increased heart rate
- Dizziness
More serious side effects can occur, such as urinary retention, liver problems, allergic reactions, and increased heart rate. Patients should contact their doctor immediately if they experience severe symptoms, including difficulty urinating, yellowing of the skin or eyes, or swelling of the face or throat.
What are the dosage recommendations and how is it prescribed?
Cobenfy is taken as an oral capsule twice a day, either one hour before or two hours after a meal. The starting dose is 50 mg/20 mg twice daily for the first two days. The dose is then increased to 100 mg/20 mg twice daily for at least five days. Depending on how well the patient tolerates the medication, the dose may be further increased to a maximum of 125 mg/30 mg twice daily.
For older adults, the starting dose is the same, but the maximum dose is lower at 100 mg/20 mg twice daily to reduce the risk of side effects.
Source:
U.S. Food and Drug Administration. Full prescribing information: [Label for NDA 216158]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216158s000lbl.pdf. Accessed 2024 Nov 21.
