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Bupropion/dextromethorphan - Axsome Therapeutics

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: 09 May 2024

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At a glance

  • 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.

  • New Molecular Entity No

Highest Development Phases

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

Most Recent Events

  • 07 May 2024 Phase-III clinical trials in Agitation (In the elderly) in Puerto Rico (PO) (NCT05557409)
  • 13 Apr 2024 Efficacy and adverse event data from the phase III ACCORD trial in Alzheimer's disease presented at the 76th Annual Meeting of the American Academy of Neurology (AAN-2024)
  • 04 Jan 2024 Axosome Therapeutics plans a pivotal phase II/III trial for Smoking withdrawal in 2024
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