Throughout Canada, the United States and internationally, therapeutic use of cannabis is increasing among patients supported by a growing consensus of medical professionals. Since doctors are generally trained to practice evidence-based medicine, the amount of research and development going into collecting clinical data and the therapeutic effects of medical cannabis is also on the rise. That said, the cannabis industry needs to innovate to adopt traditional pharmaceutical practices in order to continue making scientific advancements and to normalize cannabis as a medicine.
Cannabis contains several hundred active pharmaceutical ingredients (APIs) in the form of cannabinoids, terpenes, and flavonoids. A wide variety of cultivars, differing in their chemical composition, have been developed around the world and there are more than 2,000 known and distinct phenotypes of cannabis strains. It’s believed that the active ingredients in the cannabis plant which have specific medicinal attributes are derived from an extensive body of knowledge, largely based on feedback by patients and their caregivers backed by preclinical and observational studies.
The lack of consistency, stability, and clinical results validated through a recognized governing authority such as Health Canada, Food and Drug Administration and European Medicines Agency acknowledging cannabis and its derivatives as an approved drug prevents it from widely being considered a medicine by regulatory bodies. Clinical research providing evidence-based, scientifically validated and repeatable relationships between the plant’s active ingredients and medical efficacy is essential to obtaining regulatory and widespread medical acceptance. Traditional drug delivery systems, such as oral applications of slow release gel caps, inhalers, films, chewables, sprays, and topical applications such as dermal gels, creams and, patches, have to replace consumption by smoking, vaping, and edible oils. But we see that changing with the onset of R&D collaborations.
Enter Revive Therapeutics Ltd. Last week, WeedMD and Revive Therapeutics signed medical cannabis R&D supply and collaboration agreements. For those unfamiliar with their story, here is a quick summary of Revive Therapeutics:
- Diversified pipeline of pharmaceutical, prescription, and over the counter (OTC) products
- Diversified by therapeutic areas, time to market, and regulatory protection
- Strong IP position in cannabinoid delivery technology (i.e. topicals, patches, nasal, oral, etc.) and patent in rare liver disease (Autoimmune hepatitis)
- Experienced management team and scientific advisory board in creating new products, executing clinical studies for evidence-based product research, and dealing with regulatory bodies (Health Canada, FDA, EMA, etc.)
- Focused on inflammatory diseases more specifically in pain and inflammation, dermatology, autoimmune, and liver diseases; initially concentrating on non-alcoholic steatohepatitis (NASH) and autoimmune hepatitis (AIH)
WeedMD and Revive combined R&D goals include:
- Developing alternative delivery systems to smoking or vaporization of dried flower
- Providing for dose-to-dose consistency, quality and effects
- Changing the dosage regimen from grams of dried flower per day to mg per dose
- Allowing for dosage forms to be targeted to specific indications
- Creating sustained release and rapid release formulations for pain and sleep, respectively
- Increasing acceptance of cannabinoid-based therapies for both patients and prescribers
- Obtaining a Dealer’s License (in progress) is the natural next step that will enable us to expand our product offerings to foreign markets and broaden our patient base internationally
- Expanding product pipeline of OTC and pharmaceutical products via internal R&D, licensing, acquisitions and partnerships
- Commercializing medical cannabis products supported by clinical research and patient observational studies
- Advancing clinical development of pharmaceutical cannabinoids with US FDA approval of orphan drug designations for a number of rare diseases
“WeedMD continues to push ahead with its research and development initiatives, both independently and with research institutions to accelerate cannabinoid applications and delivery system innovations, in addition to collecting valuable data about strains and their effects,” said Dr. Luc Duchesne, Chief Scientific Officer of WeedMD. “Both WeedMD and Revive are making advances as participants in the pharmaceutical cannabis market which begins with the validation of new products and innovations through clinical-evidence and the establishment of intellectual property.”
As part of our joint R&D efforts, Revive Therapeutics will also aim to collect the pharmacoeconomic evidence required from insurers in order to support the coverage of cannabis-based medicines. Most private insurance plans do not currently cover cannabis treatment, nor is public reimbursement available, making cannabis and its therapeutic derivatives an expensive healthcare option for most patients.
It is a core part of WeedMD’s strategy and commitment to R&D, to develop and launch new treatment options for our patients.