AusCann (ASX:AC8) Receives US FDA MoC for Veterinary Drug – The Market Herald

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  • AusCann (AC8) receives its official Conference Memorandum (MoC) from the Center for Veterinary Center of the United States Food and Drug Administration (US FDA-CVM)
  • The MoC follows a successful meeting held in December last year to discuss AusCann’s cannabinoid-based veterinary medicine development program.
  • CPAT-01 aims to manage pain, inflammation and quality of life in dogs with osteoarthritis
  • AusCann is currently progressing through Phase 2C and Phase 3 trials to support an Animal New Drug Application as the next step toward US FDA-CVM approval for CPAT-01
  • Shares of the company are up 18.6% to trade at 8.3 cents

AusCann (AC8) has received its official Conference Memorandum (MoC) from the Center for Veterinary Center of the United States Food and Drug Administration (US FDA-CVM) for CPAT-01.

The MoC marked the next step in the FDA approval process following a successful Pre-Submission Conference (PSC) meeting held in early December last year.

The PSC meeting was hosted by AusCann and the FDA-CVM to discuss the development program for the approval of CPAT-01 as a veterinary drug for dogs with osteoarthritis.

The MoC essentially provides formal guidance on the development program and regulatory pathway for approval of cannabinoid-based veterinary medicine to help manage pain, inflammation and quality of life in dogs.

The meeting brief summarized the CPAT-01 program, with specific questions related to submitting an animal new drug application to get the CPAT-01 drug approved in the United States.

Additionally, AusCann has received positive recommendations regarding its approach to a
titration regimen for CPAT-01 to address cannabinoid variability. It also obtained confirmation that its safety and toxicology development plan will be sufficient, significantly reducing the time and cost required for the program.

AusCann has begun the design phase of its Phase 2C clinical efficacy trial to generate final pilot data. The data will be used to inform the design of a phase three program to support the Animal New Drug Application for CPAT-01 approval.

The company’s shares rose 18.6% to trade at 8.3 cents at 2:11 p.m. AEDT.

About Hector Hedgepeth

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