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Tramadol - Avenue Therapeutics

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Drug Profile

Tramadol - Avenue Therapeutics

Alternative Names: AVE-901; IV tramadol - Revogenex/Avenue Therapeutics; RVX 109; Tramadol hydrochloride - Revogenex/Avenue Therapeutics; Tramadol intravenous - Revogenex/Avenue Therapeutics

Latest Information Update: 02 May 2024

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At a glance

  • Originator Revogenex
  • Developer Avenue Therapeutics
  • Class Anisoles; Antidepressants; Cyclohexanols; Dimethylamines; Erectile dysfunction therapies; Opioid analgesics; Small molecules
  • Mechanism of Action Adrenergic uptake inhibitors; Opioid mu receptor agonists; Serotonin uptake inhibitors
  • 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

  • Preregistration Postoperative pain

Most Recent Events

  • 02 May 2024 Avenue Therapeutics submits an NDA application under the 505(b) regulatory pathway for Tramadol
  • 04 Jan 2024 Avenue Therapeutics and the US FDA reaches final agreement on the study design and analysis approach of the phase III safety study for Tramadol (IV)
  • 25 Jul 2023 Avenue Therapeutics plans a phase III trial for Postoperative pain in 2023 (IV)

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