Overview
The FDA has approved Cobenfy (xanomeline and trospium chloride) capsules, a new oral medication for adult schizophrenia treatment that employs a novel cholinergic receptor mechanism, representing the first such innovation in decades.
Drug Approval Details
- Cobenfy is the first schizophrenia medication to target cholinergic receptors rather than dopamine receptors.
- Approval provides an alternative to traditional antipsychotics for adults with schizophrenia.
- Bristol-Myers Squibb Company received the approval.
Clinical Trial Results
- Two 5-week, randomized, double-blind, placebo-controlled studies assessed Cobenfy in adults diagnosed per DSM-5 criteria.
- The main endpoint was the change in Positive and Negative Syndrome Scale (PANSS) total score at week 5.
- Participants treated with Cobenfy showed significant symptom reduction versus placebo in both studies.
Schizophrenia Background
- Schizophrenia affects about 1% of Americans and is a leading cause of disability globally.
- Symptoms include hallucinations, thought control difficulties, paranoia, cognitive impairment, and reduced social motivation.
- There is a higher risk of early mortality and suicide among individuals with schizophrenia.
Warnings and Contraindications
- Cobenfy carries risks of urinary retention, tachycardia, decreased gastric movement, angioedema, and potential liver damage.
- Not recommended for patients with mild hepatic impairment; contraindicated in any hepatic impairment.
- Substantially excreted by kidneys; not recommended for moderate/severe renal impairment.
- Contraindicated in cases of urinary retention, moderate/severe kidney or liver disease, gastric retention, untreated narrow-angle glaucoma, or hypersensitivity to components.
Side Effects
- Common side effects: nausea, indigestion, constipation, vomiting, hypertension, abdominal pain, diarrhea, tachycardia, dizziness, and gastroesophageal reflux.
Recommendations / Advice
- Stop Cobenfy immediately if experiencing liver disease symptoms such as jaundice, dark urine, or unexplained itching.
- Avoid prescribing Cobenfy in patients with relevant organ impairments or contraindications.
Questions / Follow-Ups
- Continued monitoring of real-world effectiveness and safety is warranted.
- Further research may clarify long-term impacts and broader patient suitability.