Auvelity Indications
Auvelity (dextromethorphan-bupropion) is FDA-approved exclusively for the treatment of major depressive disorder (MDD) in adults. 1, 2
Primary Indication
- Major Depressive Disorder (MDD): Auvelity is indicated as a treatment option for adults with MDD, representing a mechanistically novel approach that targets glutamatergic signaling through NMDA receptor antagonism and sigma-1 receptor agonism (dextromethorphan component) combined with dopamine-norepinephrine reuptake inhibition (bupropion component). 1, 2
Clinical Context for Use
Auvelity can be deployed across multiple treatment scenarios in MDD:
- First-line therapy: Can be initiated as initial pharmacotherapy for MDD. 2
- Second-line option: Appropriate when patients have failed to achieve remission with serotonin-targeting agents (SSRIs/SNRIs). 2
- Treatment-resistant depression: Suitable for patients who have not responded adequately to prior antidepressant trials. 2
- Add-on therapy: Real-world data shows 71.2% of patients initiated Auvelity as add-on treatment, most commonly combined with SSRIs (10.7%) or SNRIs (6.5%). 3
- Monotherapy: 28.8% of patients in real-world practice initiated Auvelity as monotherapy. 3
Key Clinical Advantages
- Rapid onset of action: Significant reductions in Montgomery-Åsberg Depression Rating Scale (MADRS) scores observed within 2 weeks, distinguishing it from traditional monoamine-based antidepressants that typically require 4-8 weeks. 1, 4
- High remission rates: Long-term studies demonstrate remission rates approaching 70% and response rates exceeding 80% with sustained treatment. 1
Important Limitations
- Not approved for other indications: Despite containing bupropion, Auvelity is NOT indicated for smoking cessation, seasonal affective disorder, obesity management, or any other condition for which bupropion monotherapy might be used. 1, 2
- Adult population only: No pediatric indication exists, and the boxed warning specifically highlights increased risk of suicidal thoughts and behaviors in pediatric and young adult patients. 5
- Preliminary evidence only for bipolar depression: While DXM efficacy has been preliminarily reported in bipolar depression, this is not an FDA-approved indication and requires further study. 4
Contraindications to Consider
When evaluating Auvelity for MDD, absolute contraindications include:
- Seizure disorder or history of seizures (bupropion lowers seizure threshold with 0.1% risk at therapeutic doses). 6, 7, 8
- Current or prior diagnosis of bulimia or anorexia nervosa (increased seizure risk). 7, 8
- Concurrent MAOI use or within 14 days of MAOI discontinuation. 7, 8
- Uncontrolled hypertension. 7
- Angle-closure glaucoma. 7, 8