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Dronabinol buccal - IntelGenx

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Drug Profile

Dronabinol buccal - IntelGenx

Alternative Names: CAT 310; Dronabinol AdVersa® Mucoadhesive tablet; Dronabinol buccal - IntelGenx/Tetra Bio Pharma​; Dronabinol XL; INT 0010; INT 0010/2006; INT-0028; INT0028/2011; PPP 002; REDUVO; REDUVO Adversa; Relivar

Latest Information Update: 20 Jul 2023

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At a glance

  • Originator Cannasat Therapeutics
  • Developer Cynapsus Therapeutics; IntelGenx Corp.; Tetra Bio Pharma
  • Class Antidementias; Antiemetics; Antineoplastics; Appetite stimulants; Cannabinoids; Chromans; Muscle relaxants; Non-opioid analgesics; Small molecules
  • Mechanism of Action Cannabinoid receptor CB1 agonists; Cannabinoid receptor CB2 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
  • Available For Licensing Yes

Highest Development Phases

  • Marketed Cancer pain
  • Preregistration Chemotherapy-induced nausea and vomiting
  • No development reported Neuropathic pain

Most Recent Events

  • 22 Dec 2022 Tetra Bio-Pharma receives a second Clarification Request (Clarifax) from Health Canada for dronabinol buccal's risk management plan, which is not atypical for a controlled substance drug
  • 16 Nov 2022 Tetra Bio-Pharma receives a Clarification Request (Clarifax) from Health Canada for dronabinol buccal labels
  • 14 Feb 2022 Tetra Bio-Pharma enters into a strategic partnership with Avicanna for the registration and commercialisation of dronabinol buccal (REDUVO™, AdVersa®) in Latin/South America
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