Description
Brand Names (Canada, US, EU, UK, AU)
Auvelity® (US, Canada), AXS-05 (clinical code), Bupropion-Dextromethorphan Tablets (generic name; in process of registration in the EU, UK, AU markets)
What is Auvelity and How Does It Work?
Auvelity is an extended-release oral tablet that contains Bupropion 105mg and Dextromethorphan Hydrobromide 45mg, formulated to address major depressive disorder (MDD) in adults. It represents a significant advance in psychiatric medicine, as it is the first and only FDA-approved oral NMDA receptor antagonist for depression, combining two active agents with complementary mechanisms of action.
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Bupropion is a norepinephrine-dopamine reuptake inhibitor (NDRI) and a CYP2D6 inhibitor that enhances synaptic levels of dopamine and norepinephrine.
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Dextromethorphan is a well-known cough suppressant that also acts as an NMDA receptor antagonist and a sigma-1 receptor agonist, mechanisms associated with antidepressant effects.
The synergistic action of both compounds targets both monoaminergic and glutamatergic pathways, allowing for faster therapeutic onset compared to traditional antidepressants like SSRIs or SNRIs .
Indications and On-Label Uses
Auvelity is FDA-approved for the treatment of major depressive disorder (MDD) in adults. It is not currently approved for pediatric use.
Key benefits include:
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Rapid onset of antidepressant effects, often noted within 1 week of treatment .
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Well-tolerated side effect profile with low risk of sedation, weight gain, or sexual dysfunction.
Off-Label and Investigational Uses
While not FDA-approved for these indications, the combination of Bupropion and Dextromethorphan is being studied for:
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Treatment-resistant depression (TRD)
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Cognitive disorders such as Alzheimer’s disease and traumatic brain injury (TBI)
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Smoking cessation, given bupropion’s existing approval for this use
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Chronic pain and neuropathic pain management (due to NMDA antagonism)
These investigational uses are based on emerging evidence and ongoing clinical trials .
Clinical Evidence and Auvelity Reviews
Clinical trials (GEMINI, ASCEND) have shown that patients taking Auvelity had statistically significant improvements in MADRS scores compared to placebo and even traditional antidepressants. In a 6-week trial, remission was achieved in 39.5% of Auvelity users vs 17.3% in the placebo group .
Patients and professionals have noted benefits in:
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Rapid symptom relief
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Improved energy and cognitive clarity
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Minimal sedation
These auvelity reviews indicate favorable tolerability and a unique mechanism that sets it apart from first-line antidepressants.
Auvelity Ingredients and Formulation
Each extended-release tablet contains:
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Bupropion Hydrochloride 105mg
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Dextromethorphan Hydrobromide 45mg
The formulation is designed to maintain stable plasma levels and extend the half-life of dextromethorphan by inhibiting its metabolism via bupropion’s CYP2D6 inhibition.
Inactive ingredients: hydroxypropyl cellulose, magnesium stearate, mannitol, and others (may vary by manufacturer).
Safety Profile, Side Effects, and Contraindications
Common side effects:
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Dizziness
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Dry mouth
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Somnolence or insomnia
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Decreased appetite
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Increased blood pressure
Contraindications:
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Use of monoamine oxidase inhibitors (MAOIs)
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Seizure disorders
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Bulimia or anorexia nervosa
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Alcohol or sedative withdrawal
Serious risks include seizures and suicidal thoughts in young adults, though incidence is lower than with other antidepressants.
Drug interactions: caution is advised when combining with serotonergic or CNS-active agents. Always consult with a healthcare professional before starting Auvelity .
Auvelity Cost and Availability
Auvelity cost varies significantly depending on the region and insurance coverage:
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In the US, a 30-day supply may range from $500 to $1,200.
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Generic versions may be available under bupropion dextromethorphan tablet or similar nomenclature in some markets.
Discount programs and online pharmacy platforms may offer competitive prices. It is now possible to auvelity buy online through certified pharmacy websites.
Auvelity Generic and Market Access
As of 2025, there is no FDA-approved generic version of Auvelity, although bupropion and dextromethorphan are individually available in generic forms. The dual formulation is patented until at least 2037, limiting generic entry.
However, international pharmacies may offer non-branded equivalents under varying regulatory conditions. Always verify legitimacy and compliance with local regulations.
How to Use Auvelity
Recommended dosage:
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Start with one tablet daily for 3 days, then increase to one tablet twice daily, with at least 8 hours between doses.
Do not exceed 2 tablets in 24 hours. Tablets should be taken orally with or without food.
Conclusion
Auvelity is a scientifically advanced antidepressant that offers rapid relief for major depressive disorder via a unique mechanism. Its dual action on monoaminergic and glutamatergic systems provides a powerful alternative for patients not responding to traditional treatments. Given increasing auvelity reviews, wide-scale physician support, and expanding global access, Auvelity is positioned as a next-generation solution in psychiatric care.
References
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https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-new-fast-acting-antidepressant
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https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215554s000lbl.pdf
Frequently Asked Questions (FAQ)
What is Auvelity used for?
Auvelity is used to treat major depressive disorder (MDD) in adults. It works through a unique dual mechanism involving dopamine and NMDA pathways.
How does Auvelity work?
Auvelity combines bupropion and dextromethorphan to increase dopamine and norepinephrine levels while modulating glutamate signaling, leading to rapid antidepressant effects.
What are the side effects of Auvelity?
Common side effects include dizziness, dry mouth, insomnia, and nausea. Serious but rare risks include seizures and suicidal thoughts.
Is there a generic for Auvelity?
As of now, there is no FDA-approved generic. However, generic equivalents of its individual components may be available.
Can I buy Auvelity online?
Yes, you can auvelity buy online through licensed pharmacy websites that sell bupropion dextromethorphan tablet formulations.
Reviews
There are no reviews yet.