The subsidiary of Tetra Bio-Pharma Inc. called PhytoPain Pharma Inc. is a pharmaceutical firm that concentrates on commercializing and improving therapeutic cannabis-based products to treat pain and other medical disorders. They just revealed that they have finally completed their pre-IND meeting for the PPP001 dried cannabis drug product with the USA Food and Drug Administration.
During the meeting last January 2017, they were accompanied by the Center for Drug Evaluation and Research along with the Division of Anesthesia, Analgesia and Addiction Products. Later this year, Dr. Chamberland, the Chief Scientific Officer and Regulatory Affairs, further added that their company aims to submit a clinic trial application if Health Canada allows them.
The FDA gave them all the needed instruction on the outline of the Phase I trial involving healthy volunteers and the general product development program. This consists of the marketing requirements, medical and nonclinical device, and quality. He says that their meeting with the FDA was a perfect timing because it will permit them to alter their clinical development if they get the approval for the orphan drug indications.
Dr. Chamberland, M.Sc., Ph.D. says that they are pretty content with the result since the FDA guidance provided them a definite way to develop from the initial to the late stages of clinical progress. They even added that following the US FDA regulations is a part of their commitment to the commercialization of Cannabis as a prescription controlled drug. Moreover, the corporations are planning to pursue reimbursement for patients by insurers.