COBENFY

Following COBENFY administration, xanomeline area under the plasma concentration-time curve during a 12-hour dosing interval (AUC 0-12 ) at steady state and maximum concentration (C max ) increased 50% when the COBENFY dose increased from 100 mg/20 mg twice daily to 125 mg/30 mg twice daily. Trospium exposures increase dose-proportionally over the COBENFY dosage range of 100 mg/20 mg twice daily to 125 mg/30 mg twice daily. Pharmacokinetic properties of COBENFY are provided in Table 3. Table 3: ...

The efficacy of COBENFY for the treatment of schizophrenia in adults was evaluated in two placebo-controlled studies with identical designs (N = 470).

Study 1(NCT04659161) and

Study 2(NCT04738123) were five-week, randomized, double-blind, placebo-controlled, multi-center studies in adult patients with a diagnosis of schizophrenia according to the DSM-5 criteria. In Study 1 and Study 2, patients randomized to COBENFY were started on an initial dose of 50 mg/20 mg orally twice daily for the first 2 days and if tolerated, followed by 100 mg/20 mg orally twice daily for the remainder of Week 1 (...

The following clinically significant adverse reactions are described elsewhere in the labeling:

• Risk of Urinary Retention [see Warnings and Precautions (5.1) ]
• Risk of Use in Patients with Hepatic Impairment [see Warnings and Precautions (5.2) ]
• Risk of Use in Patients with Biliary Disease [see Warnings and Precautions (5.3) ]
• Decreased Gastrointestinal Motility [see Warnings and Precautions (5.4) ]
• Risk of Angioedema [see Warnings and Precautions (5.5) ]
• Risk of Use in Patients with...

COBENFY is contraindicated in patients with:

• urinary retention [see Warnings and Precautions (5.1) ] .
• moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment [see Warnings and Precautions (5.2) ] .
• gastric retention [see Warnings and Precautions (5.4) ] .
• history of hypersensitivity to COBENFY or trospium chloride. Angioedema has been reported with COBENFY and tros...

• Risk of Urinary Retention: COBENFY can cause urinary retention. Geriatric patients and patients with bladder outlet obstruction and incomplete bladder emptying are at increased risk. Monitor patients for symptoms of acute urinary retention. ( 5.1 )
• Risk of Use in Patients with Hepatic Impairment: COBENFY is contraindicated in patients with moderate to severe hepatic impairment and is not recommended in patients with mild hepatic impairment. ( 5.2 )
• Risk of Use in Patients with Biliary Dise...

7 DRUG INTERACTIONS

• Drugs Eliminated by Active Tubular Secretion: Monitor for increased frequency and/or severity of adverse reactions related to COBENFY and to drugs eliminated by active tubular secretion. ( 7.1 )
• Strong CYP2D6 Inhibitors: Monitor for increased frequency and/or severity of COBENFY-related adverse reactions. ( 7.1 )
• Sensitive Substrates of CYP3A4 or P-glycoprotein: Monitor f...