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Bupropion/dextromethorphan - Axsome Therapeutics

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Drug Profile

Bupropion/dextromethorphan - Axsome Therapeutics

Alternative Names: AUVELITY; AXS-05; Dextromethorphan-HBr-bupropion-HCl; Dextromethorphan/bupropion; Dextromethorphan/bupropion modulated delivery tablet

Latest Information Update: 10 Jun 2025

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At a glance

  • Originator ANTECIP BIOVENTURES
  • Developer Axsome Therapeutics; Duke University
  • Class Anti-inflammatories; Antidementias; Antidepressants; Behavioural disorder therapies; Morphinans; Propiophenones; Small molecules; Smoking cessation therapies
  • Mechanism of Action Adrenergic receptor antagonists; Cytochrome P-450 CYP2D6 inhibitors; Dopamine uptake inhibitors; Nicotinic receptor antagonists; NMDA receptor antagonists; Norepinephrine plasma membrane transport protein inhibitors; Serotonin plasma membrane transport protein inhibitors; Sigma-1 receptor agonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No

Highest Development Phases

  • Marketed Major depressive disorder
  • Phase III Agitation
  • Phase II Smoking withdrawal

Most Recent Events

  • 25 Apr 2025 Axsome Therapeutics terminates the phase III long term extension trial in Agitation in US and Puerto Rico, due to the completion of the overall program objectives (NCT06736509)
  • 03 Mar 2025 Axsome Therapeutics announced the intention to submit a New Drug Application (NDA) to the US FDA for Agitation in 3Q of 2025
  • 10 Feb 2025 Axsome Therapeutics enters into a settlement agreement with Teva Pharmaceuticals resolving all patent litigation related to bupropion/dextromethorphan

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