- Companies collaborating on development of patent-pending sustained release oral cannabinoid formulation
- Formulation doubles or triples time period in which cannabinoid doses maintain their therapeutic effects
- Formulation enables better regulation of dosing schedules and improvement of patient compliance
Emblem Corp. (TSX.V: EMC) (OTC: EMMBF), a company licensed to cultivate and sell medical marijuana in Canada under the Access to Cannabis for Medical Purposes Regulations, has entered into a collaboration and licensing agreement with Canntab Therapeutics Limited to collaborate on the preclinical formulation, clinical development, regulatory approval, manufacturing and commercialization of Canntab’s patent-pending oral sustained release formulation for cannabinoids.
Through this agreement, Emblem gains the exclusive right to Canntab’s patents and expertise in Canada to develop, commercialize, use, sell and offer the sustained release product, which will be sold under the Emblem brand. The license does not grant Emblem the right to import or export the product.
Emblem or Canntab will manufacture the product, once Canntab obtains the necessary licensing for such manufacture.
As stipulated in the agreement, Emblem will make payments to Canntab once certain milestones have been achieved relative to stability studies, bioavailability studies and regulatory approval of the product. Further, the agreement states that Emblem will make royalty payments to Canntab based on gross product sales.
In addition, the two companies plan to collaborate on the preclinical formulation, clinical development, regulatory approval and commercialization of various additional pharmaceutical formulations containing cannabinoids.
Considerable evidence exists showing the efficacy of cannabinoids in treating a variety of conditions, such as chronic pain, anxiety, nausea, sleep disorders and spasticity in multiple sclerosis patients. The majority of conventional immediate release dosage forms, like capsules and tablets, release an active drug component immediately following oral administration. In formulating conventional drug products, there is no deliberate effort to alter the drug release rate.
In sustained release dosage forms, active pharmaceutical ingredients are released at a predetermined rate, so constant drug concentration can be maintained over a specific time period. This results in a single dose having greater duration of action and, frequently, a reduction of side effects. The end goal is typically to improve the therapeutic outcome and/or enhance patient compliance.
In the case of cannabinoids, the therapeutic effects of immediate release dosage forms often diminish within four to six hours, which necessitates re-administering the dosage and risks a reduction in patient compliance. Canntab’s sustained release product, however, has been designed to release cannabinoid content over at least a 12-hour period.
Considerable evidence shows the effectiveness of cannabis in treating conditions like neuropathic pain, which has been estimated to affect more than two million Canadians. The pharmaceutical market for addressing these patients’ needs was approximately $500 million in 2016. Sustained release formulations of pharmaceutical products to treat chronic conditions—conditions necessitating 24-hour relief for patients—is of especial value.
For pharmaceutical ingredients that are typically short-acting, like cannabinoids, sustained release formulations enable dosage schedules that are more convenient, offer longer action duration and are better accepted by health care professionals and patients. The patent-pending extended release formulation being collaboratively developed by Emblem and Canntab will enable medical professionals, for the first time, to establish proper dosages for patients and will, for the patients, make it easier to take medical cannabis.
Emblem believes the development of advanced dosage forms, and the pharmacokinetic and clinical research associated with this development, will effectively advance cannabinoid therapy. The company also anticipates that introducing sustained release cannabinoid formulations that are easily titratable will significantly increase the market for cannabinoid-based medications—especially for the treatment of conditions like chronic neuropathic pain.
For more information, visit the company’s website at www.EmblemCannabis.com
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