Tetra BioPharma has announced that the Therapeutic Drug Directorate at Health Canada has issued a “No objection letter” in approving a Phase 1 study to test a vaporized version of PPP001 for the treatment of chronic pain, the main feature of fibromyalgia.
The study will investigate the pharmacokinetics — the time the body takes to absorb, distribute, and excrete the substance — and the safety of the vaporized medicine.
PPP001 is a cannabinoid-based product being tested in a Phase 3 clinical trial (NCT03339622), currently recruiting, for its efficacy in relieving pain in people with advanced cancer.
This approval comes four months after the announcement of a collaboration between Tetra BioPharma and Storz & Bickel to develop a version of PPP001 administered using the Mighty Medic vaporizer — a portable herbal vaporizer approved by Health Canada for the use of cannabis. The collaboration’s protocol was approved earlier this year by a Canadian independent ethics board.
Vaporized delivery provides an alternative to smoking cannabis and cannabis-derived substances. Additionally, it could represent an alternative to opioid use for patients suffering from chronic pain conditions, such as fibromyalgia.
Opioids are the common line of treatment for chronic pain but they can cause negative side effects, namely addiction. The positive effects of cannabis and cannabis-derived substances to alleviate pain and other conditions have been previously documented.
“We are pleased to announce this critical Phase 1 trial focused on the [pharmacokinetics] and safety of our PPP001 pellet delivered by vaporization,” Dr. Guy Chamberland, CEO and CSO of Tetra Bio-Pharma, said in a press release.
“Over the last three months we have analyzed the composition of the vapor. This data combined with the results of this Phase 1 [study] will provide the critical pharmacological information required by physicians to adequately guide future efficacy studies in patients who suffer from a chronic condition such as fibromyalgia, where there are limited treatment options and there is a large unmet medical need. It may also provide an alternative mode of delivery for those patients who prefer not to smoke,” he said.
It is expected that the results from the study and characterization of the compounds present in the vapor would provide the necessary evidence to move forward the investigation targeted to specific chronic diseases, such as fibromyalgia. The study results are expected before the end of 2018.
Tetra BioPharma is a biopharmaceutical company and leader in the discovery and development of cannabinoid-derived treatments. It has a Health Canada-approved and an FDA-revised clinical program that aims at making available new prescription medications and treatments to patients and healthcare providers.
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