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Aphria Distinguished by its Stake in Tetra BP:Aphria has worked to distinguish itself from just any marijuana grower out there. They have done so in a number of ways, but the best by far is their partnership with fellow Canadian company, Tetra Bio Pharma, to bring smokeable dried cannabis through the prescription drug clinical trials process, from Phase I through Phase III, and obtain a DIN drug ID number from Health Canada and the US FDA. Yes, it is really happening.


Indeed, their partner has made numerous comments as to the reactions of their prior clinical trials by the FDA and Health Canada, both regulators having a lot of positive things to say about the surprisingly good results. Now they are jumping right in and have completed their CTA clinical trial application for the 3rd phase trial. PPP001 it is currently called, which stands for Phyto Pain Pharma drug #1 (PPP is a 100%-owned subsidiary of Tetra BP).
 

The Recent Clinical Trial of PPP001 Gave Strong Insight:
In a recent online interview, Dr. Guy Chamberlain, Tetra's Chief Scientific Office and Master Herbalist, said about their last clinical trial on PPP001:


"It's given us a very good insight and understanding as to why some of our marijuana products are actually quite superior to the synthetic THC drugs, so this for us has been very interesting, and last month, going over this data (of PPP001's earlier clinical study) ... now we are beginning to understand why patients really want to smoke [versus take the synthetic drugs]." I am familiar with some aspects of this and patients are prefering the natural product because they have been getting a lot of bad reactions to the lab-created drugs, like nausea and headaches, which just removes one problem and replaces it with another or even two or more problems, and who wants that? They were able to look at the components of the PPP001 and how it remained in the blood and compared those and the lack of side effects to the known results of the synthetic drugs and their side effects, and draw some important conclusions as to the whys and wherefores.


 Aphria & Partner Moving Trial Foward in Anticipation:Now Aphria and Tetra are excited that they have been enabled to proceed to Phase III and the paperwork is readied for submission. Applications are reviewed and approved within 30 days, and few are rejected at this stage. If there is something the FDA or Health Canada wants to see, they typically help them add it into the study.


 From excerpts of the Phase III news: The corporation worked with physicians of Sante Cannabis to design a clinical trial that would demonstrate the safety and efficacy of PPP001 in terminal cancer patients. In addition, as part of the clinical trial, Tetra will collect the pharmacoeconomics evidence required from provincial insurers in order to support the reimbursement of the first cannabis prescription drug. As part of its early phase clinical research, Tetra developed dosing strategies to minimize moderate and severe side effects in patients. This dosing strategy was developed in healthy volunteers over the last few months and has shown to be effective in reducing the severity of the side effects and preventing certain serious ones. This allows TBP to initiate its Phase 3 trial based on clinical data proposing a more tolerable approach to consuming smoked cannabis and to assess PPP001 in terminal cancer patients.  

 

This is a significant step in the development of a safe, tolerable and effective new drug for the management of chronic pain in terminal cancer patients with co-morbidities. This will be the first Phase 3 clinical trial studying the therapeutic benefits of a smoked dried cannabis prescription drug in terminal cancer patients. Due to the status of cannabis under the Controlled Drugs and Substances Act in Canada, over the last four months the corporation developed procedures and methods that would both satisfy the Narcotic Controls Regulations and ensure the protection of patients consuming the cannabis. The corporation is confident that these procedures will be well received by Health Canada as they ensure compliance with both the Food and Drug Act and Controlled Drugs and Substances Act. 

 

PPP001 aims to be the first smokable marihuana for advanced cancer pain under prescription. It is a dried cannabis pellet designed to be smoked in an inhalation device specifically developed for this product.

Footnote by MightyMaven:
The company expects approval to start within the next thirty days, having maintained a close contact with both US and Canadian regulatory agencies.

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