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Bupropion/dextromethorphan - Axsome Therapeutics

Drug Profile

Bupropion/dextromethorphan - Axsome Therapeutics

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

Latest Information Update: 16 Sep 2020

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At a glance

  • Originator ANTECIP BIOVENTURES
  • Developer Axsome Therapeutics; Duke University
  • Class Anti-inflammatories; Antidepressants; Morphinans; Propiophenones; Small molecules; Smoking cessation therapies
  • Mechanism of Action Adrenergic receptor antagonists; 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

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

Most Recent Events

  • 14 Sep 2020 Updated efficacy data from the phase III GEMINI trial in Major depressive disorder released by Axsome Therapeutics
  • 31 Aug 2020 Axsome Therapeutics announces intention to submit NDA for bupropion/dextromethorphan in Agitation (AD agitation)
  • 31 Aug 2020 Axsome Therapeutics completes Breakthrough Therapy meeting with the US FDA
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