Dronabinol buccal - IntelGenx

Drug Profile

Dronabinol buccal - IntelGenx

Alternative Names: CAT 310; Dronabinol AdVersa® Mucoadhesive tablet; Dronabinol XL; INT 0010; INT 0010/2006; INT-0028; INT0028/2011; PPP 002; Relivar

Latest Information Update: 30 Jul 2018

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At a glance

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

Highest Development Phases

  • Phase III Cancer pain
  • No development reported Neuropathic pain
  • Discontinued Chemotherapy-induced nausea and vomiting

Most Recent Events

  • 26 Jul 2018 Tetra and IntelGenx intend to file Clinical Trial Applications with Health Canada for comparative pharmacokinetic and opioid sparing trials, to support development for the 505(b) and opioid sparing indications, respectively, in Q3 018 (945776)
  • 26 Jul 2018 The US FDA grants Type B and C meetings letters to provide regulatory guidance for dronabinol's approval in Chemotherapy induced nausea and vomiting and Anorexia
  • 13 Jun 2018 Tetra Bio-Pharma expects to commence a phase II study in chronic pain with PPP002 in third quarter of 2018
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