Good
Mostly Aligned
Patient Risk:
Low
Summary
Mostly aligns with the provided FDA label excerpts for composition and certain adverse effects/interaction concepts, but includes several claims that are not supported by the supplied label text (notably ketamine/esketamine usage in treatment-resistant depression and clinic settings) and over-generalizes interaction/side-effect language without explicit label support in the provided sections.
Category Scores
Accurate Statements
Auvelity is a combination antidepressant containing dextromethorphan (DM) and bupropion.
DESCRIPTION states AUVELITY contains dextromethorphan hydrobromide and bupropion hydrochloride (11 DESCRIPTION).
Auvelity’s bupropion component may cause insomnia or activation.
Adverse Reactions table in provided label includes 'Insomnia' (4% vs 2%) and 5 WARNINGS AND PRECAUTIONS includes 'Activation of Mania or Hypomania' (5.4).
Auvelity’s bupropion component may cause nausea.
Provided label includes 'Nausea' as an adverse reaction in Study 1 (13% vs 9%) and 'Nausea' in Table 3 for agitation associated with Alzheimer’s disease (5% vs 3%) (6.1 Clinical Trials Experience).
Auvelity’s bupropion component may involve medication-interaction concerns.
7.1 lists clinically important drug interactions for AUVELITY, including bupropion-related seizure threshold risk ('AUVELITY contains bupropion which can cause seizure') and other interaction sections (7 DRUG INTERACTIONS).
Auvelity’s dextromethorphan component may cause sedation or dizziness in some patients.
Label states AUVELITY may cause dizziness and provides dizziness incidence (5.7 Dizziness). It also lists 'Somnolence' and 'Somnolence includes Somnolence, Hypersomnia' in Table 2/3 (6.1 Clinical Trials Experience).
Auvelity’s dextromethorphan component may have potential interaction risks with other serotonergic or psychoactive drugs.
7.1 states concomitant use with other serotonergic drugs increases risk of serotonin syndrome (table section 'Serotonergic Drugs'). It also discusses 'Monoamine Oxidase Inhibitors (MAOIs)' and increased risk of hypertensive crisis and serotonin syndrome.
AUVELITY is indicated for the treatment of major depressive disorder (MDD) in adults.
14 CLINICAL STUDIES / 1.1 Major Depressive Disorder: 'AUVELITY is indicated for the treatment of major depressive disorder (MDD) in adults.'
Unsupported Statements
Ketamine or esketamine-based approaches are often used in treatment-resistant depression.
No ketamine/esketamine claims are present in the supplied FDA label excerpts.
Ketamine or esketamine-based approaches are typically used in clinic settings.
No ketamine/esketamine claims are present in the supplied FDA label excerpts.
Contradictions
Important Omissions
The label excerpt provided does not support attributing specific side effects (e.g., insomnia/activation, nausea) to specifically the bupropion component versus the dextromethorphan component; the response language is component-specific.
Importance:
Moderate
Safety Assessment
Potential Patient Risk:
Low
The supported statements concern composition and general adverse reaction/interaction possibilities that are consistent with the provided label excerpts. Unsupported ketamine/esketamine statements are not directly label-grounded but also do not alter AUVELITY dosing/safety directly within the provided evaluation scope.
Regulatory Assessment
| On Label |
Yes |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
Moderate |
Recommendation
Mostly Aligned
Primary Issue
Two ketamine/esketamine claims are not supported by the supplied FDA label excerpts.
Suggested Improvement
Remove or revise ketamine/esketamine assertions, and avoid attributing adverse effects to a specific component unless the provided label text explicitly supports that component-level causality.