Cannabinoid Drug to Become Available for Fibromyalgia Patients in Canada
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Tetra Bio-Pharma, a leader in cannabinoid-based drug discovery and development, has announced a co-development agreement with Storz & Bickel to use a specialized medical device known as the Mighty Medic, in combination with its PPP001 prescription drug as well as with additional indications and a future proprietary cannabinoid formulation. The Mighty Medic is a portable herbal vaporizer for cannabis use approved by Health Canada as a Class 11 medical device and as such, is eligible for reimbursement. The agreement allows Tetra to effectively bring PPP001 to patients suffering from fibromyalgia and other chronic pain conditions, significantly expanding the market potential for PPP001.
Fibromyalgia affects about 4 million U.S. adults or about 2% of the adult population. The cardinal symptom associated with the condition is pain that can be deep, sharp, dull, throbbing, or aching, affecting the muscles, tendons, and ligaments around the joints throughout the entire body. Treatments aimed at pain relief are the primary treatment intervention including an increasing use of opioids. Among the most commonly prescribed medications used to treat fibromyalgia are Lyrica, Cymbalta, Xyrem, and Vimpat.
PPP001 is a cannabinoid-based product that is currently being studied in Phase 3 Health-Canada approved clinical trial for advanced cancer pain. Tetra will use a bridging strategy to leverage the clinical data that has been generated with the smokable formulation of PPP001, to expedite the marketing requirements in these indications and reduce the time needed to bring these products to market. The combination product of PPP001 with the Mighty Medic would signify an important economic benefit for patients.
According to Dr. Gordon D. Ko, MD, FCFP(EM), FRCPC, Ph.D., “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,” said Dr. Ko. “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.” Dr. Ko is Medical Director, Fibromyalgia clinics and Adjunct Lecturer at The Canadian Centre for Integrative Medicine, (Markham, Ontario) and Sunnybrook Health Sciences Centre, University of Toronto.
As a prescription drug, PPP001 will be eligible for insurance coverage. In Canada, only Class II, III, and IV medical devices are eligible for reimbursement under provincial health care insurance programs.
Tetra and Storz & Bickel will also collaborate on the development of another inhalation cannabinoid-based prescription drug. The drug-device combination product will target cancer patients and Tetra will use a similar bridging strategy to minimize marketing requirements and reduce time-to-market.