AUVELITY

AUVELITY is a combination of dextromethorphan and bupropion. Bupropion inhibits the metabolism of dextromethorphan via CYP2D6. Dextromethorphan when co-administered with bupropion displays nonlinear pharmacokinetics at steady state, with greater than dose-proportional changes in AUC and C max for varying doses of dextromethorphan [60 to 120 mg (0.67-1.33 times the maximum recommended dose of AUVELITY)] and less than dose-proportional changes for varying doses of bupropion [150 to 300 mg (0.71-1....

The efficacy of AUVELITY for the treatment of MDD in adults was demonstrated in a placebo-controlled clinical study (

Study 1NCT04019704 ) and confirmatory evidence which included a second study comparing AUVELITY to bupropion hydrochloride sustained-release tablets (

Study 2NCT03595579 ).) In Study 1, adult patients (18 to 65 years of age) who met the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for MDD were randomized to receive AUVELITY (45 mg of dextromethorphan hydrobromide and 105 mg of bupropion hydrochloride) twice daily (N=156) or placebo twice daily (N=162...

The following adverse reactions are discussed in more detail in other sections of the labeling: Suicidal Thoughts and Behaviors in Adolescents and Young Adults [see Warnings and Precautions ( 5.1 )] Seizure [see Warnings and Precautions ( 5.2 )] Increased Blood Pressure and Hypertension [see Warnings and Precautions ( 5.3 )] Activation of Mania or Hypomania [see Warnings and Precautions ( 5.4 )] Psychosis and Other Neuropsychiatric Reactions [see Warnings and Precautions ( 5.5 )] Angle-closure G...

AUVELITY is contraindicated in patients: with a seizure disorder [see Warnings and Precautions ( 5.2 )] . with a current or prior diagnosis of bulimia or anorexia nervosa as a higher incidence of seizures was observed in such patients treated with the immediate-release formulation of bupropion [see Warnings and Precautions ( 5.2 )] . undergoing abrupt discontinuation of alcohol, benzodiazepines, b...

Seizure: Risk is dose-related. Discontinue if seizure occurs. ( 4 , 5.2 ) Increased Blood Pressure and Hypertension: AUVELITY can increase blood pressure and cause hypertension. Assess blood pressure before initiating treatment and monitor periodically during treatment. ( 5.3 ) Activation of Mania or Hypomania: Screen patients for bipolar disorder. ( 5.4 ) Psychosis and Other Neuropsychiatric Reactions: Instruct patients to contact a healthcare provider if such reactions occur. ( 5.5 ) Angle-Clo...

7 DRUG INTERACTIONS Strong CYP2D6 inhibitors: Recommended dosage is one tablet by mouth once daily in the morning. ( 2.4 , 7.1 ) Strong CYP2B6 inducers: Avoid use. ( 7.1 ) CYP2D6 Substrates: Increases the exposures of drugs that are substrates of CYP2D6. ( 7.1 ) Digoxin: May decrease plasma digoxin levels. Monitor digoxin levels. ( 7.1 ) Drugs that lower seizure threshold: Coadministration may inc...