Tetra Bio-Pharma has announced an agreement with Storz & Bickel to use a specialty medical device known as the Mighty Medic in the development of its investigational PPP001 therapy for pain relief in patients with fibromyalgia and other chronic pain conditions.
Mighty Medic is a Health Canada-approved portable herbal vaporizer for the use of cannabis. PPP001 — a cannabinoid-based product — is currently being tested in a Phase 3 clinical trial (NCT03339622) for pain relief in late-stage cancer patients. Tetra aims for it to be the first smokeable cannabinoid product available by prescription in Canada to treat advanced cancer pain.
This new collaboration will allow the company to expand the market potential for PPP001 to patients with other chronic pain conditions, such as fibromyalgia.
Fibromyalgia patients experience significant pain that can be deep, sharp, dull, throbbing, or aching. The pain can occur in multiple regions throughout the body including muscles, tendons, and ligaments.
“Fibromyalgia is difficult to treat and there is no one ‘magic bullet.’ As practitioners we have the daunting task of moving our patients from unrelenting neuropathic pain to improved function and a better quality of life,” Gordon D. Ko, MD, PhD, medical director of fibromyalgia clinics at The Canadian Centre for Integrative Medicine and Sunnybrook Health Sciences Centre, said in a press release.
Current treatments for pain relief in fibromyalgia patients increasingly include the use of opioids — which can lead to significant negative long-term effects. Some of the most common prescription medications include Lyrica (pregabalin), Cymbalta (duloxetine), Xyrem (sodium oxybate), and Vimpat (lacosamide).
A potentially safer strategy for pain relief may be the use of products derived from cannabis.
“The clinical use of medical cannabis in the management of fibromyalgia suggests these patients obtain significant relief. Moreover, the potential to reduce opioid use for these patients is a foremost consideration of using the Mighty Medic to deliver the cannabinoids and terpenes contained in PPP001 by inhalation,” Ko said.
By using a bridging strategy through the collaboration with Storz & Bickel to use its already-approved Mighty Medic, Tetra can take advantage of currently available clinical data on PPP001 to help accelerate the marketing requirements and lessen the time needed to bring the product to market.
Additionally, the combination would provide cost savings to patients. If PPP001 is approved as a prescription therapy, it will be eligible for insurance coverage in Canada. Additionally, the Mighty Medic is a class II medical device, which means it is also eligible for reimbursement. Only Class II, III and IV medical devices are eligible for reimbursement under Canada’s provincial insurance programs.
The collaboration between Tetra and Storz & Bickel also extends to the development of another inhalation cannabinoid-based prescription therapy targeting cancer patients. Tetra plans to use a similar bridging strategy with Storz & Bickel to bring this formulation to market.