PhytoPain Pharma Inc. (“PPP”), a subsidiary of Tetra Bio-Pharma Inc. a pharmaceutical company focused on developing and commercializing therapeutic cannabis-based products for the treatment of pain and other medical conditions announces that it has completed its pre-IND meeting with the USA Food and Drug Administration (“FDA”) for its PPP001 dried cannabis drug product.
The meeting was held in January 2017 with the Division of Anesthesia, Analgesia, and Addiction Products (“DAAAP”), Center for Drug Evaluation and Research (“CDER”).
The FDA provided all the necessary guidance on the design of the Phase I trial in healthy volunteers and the overall product development program, including quality, nonclinical and the medical device, and on marketing requirements. Dr. Chamberland, M.Sc., Ph.D., Chief Scientific Officer and Regulatory Affairs, commented We could not be more pleased, as the FDA guidance gave us a clear path to progress from early to late phase clinical development.
Adhering to the US FDA regulations is part of Tetra Bio-Pharma’s
dedication to the commercialization of Cannabis as a prescription controlled drug and the corporations plan to seek reimbursement by insurers for patients.
