CanniMed Ltd. Receives Approval from Health Canada for Cannabis Oils

Patient Orders to be Fulfilled Immediately

SASKATOON, Jan. 12, 2016 /CNW/ - CanniMed Ltd. has successfully fulfilled all of Health Canada's inspection requirements and has been granted a Section 56 Supplemental Licence under the Marihuana for Medical Purposes Regulations (MMPR). This approval officially gives CanniMed the go ahead to begin sales of edible cannabis oils.

CanniMed has strategically developed three edible cannabis oil products as a complement to the consistent and successful line of seven CanniMed^® herbal products currently available. Patient engagement and requests helped to streamline the research and development into the new products. 

Registered patients can begin placing orders for CanniMed^® Oil 18:0, CanniMed^® Oil 10:10 and CanniMed^® Oil 1:20 today.

"A significant percentage of our current patients are interested in exploring this alterative preparation of their medical cannabis," said Brent Zettl, President and CEO, CanniMed Ltd. "Cannabis oils are gaining in awareness, and will be a welcome change for patients with chronic or acute respiratory related conditions or those who prefer to manage their symptoms through an oral or edible dose delivery system."

CanniMed Oils Production Process

CanniMed^® Oils are made using only dried cannabis flowers – no leaf, trimmings or waste material – and are manufactured using a food-grade alcohol process, which allows for additional research and development into future products for even greater dose flexibility.

Food-grade alcohol is pumped through compressed cannabis flower material, extracting the THCA (delta-9-tetrahydrocannabiolic acid), CBDA (cannabidiolic acid) and other medicinal ingredients. The alcohol and excess water is then removed through evaporation, resulting in a pure cannabis resin.

Olive oil is added at this stage. Once heated, the THCA and CBDA become THC and CBD through a heat-induced reaction called decarboxylation. This process is how the medicinal ingredients in the oils become active, meaning patients do not need to additionally heat the cannabis, like through a vaporizer when herbal cannabis is used.

Additional olive oil is added prior to being bottled to ensure the correct concentrations of THC and CBD.

Olive oil was selected as the carrier agent because it is the most unlikely product to bring about sensitivities or allergies.

This industry-leading process ensures product consistency - each order will be delivered with the same potency, resulting in a consistent dose.

"With the advent of high quality therapeutic cannabis oil, accurate dosing and titration to achieve optimal benefits, is now available for a much wider range of patients," said Dr. Gaylord Wardell, MD, BSc, FPM, Pain Consultant at the Wardell Centre for Chronic Pain Disease, Past President of the Pain Society of Alberta and President Elect of the Alberta Medical Association Section of Chronic Pain. "The precision dosing of the oils will eliminate a major concern regarding the use of medical cannabis, making the potential value of cannabis a reality for a much larger patient population."

Cannabis Oil Precautions

When ingested, cannabis oil is processed through the liver. Compared to when cannabis is inhaled through vapor or smoke into the lungs and takes effect almost immediately, oil preparations will have a much slower onset time and the effects will last longer.

It can take anywhere from one to one and a half hours before patients notice the effects and can take two to four hours to reach its peak effect. To avoid overconsumption, patients are encouraged to wait four hours after the first dose before taking a second.

About CanniMed and Prairie Plant Systems

CanniMed Ltd. was the first producer to be licensed under the Marihuana for Medical Purposes Regulations (MMPR) and has the longest growing history as a result of the parent company, Prairie Plant Systems Inc., being the sole supplier for the entirety of Health Canada's former medical marijuana system.

Prairie Plant Systems, the cultivation arm of the company, follows Good Manufacturing Practices (GMP) regulations, the criteria used to manufacture all pharmaceuticals in Canada. This industry-leading production excellence, including a 281-point quality control process, ensures product consistency and patient safety.

The company has a strong corporate priority to design and execute clinical research that will close the gap between the anecdotal benefit and evidence based medicine in order to standardize care. Patient recruitment has begun on the Health Canada approved CAPRI Trial (Cannabinoid Profile Investigation of Vaporized Cannabis in Patients with Osteoarthritis of the Knee), a randomized, double blind, placebo controlled, proof-of-concept, crossover clinical trial of single dose vaporized cannabis in adults with painful osteoarthritis of the knee.

Prairie Plant Systems is the only Licensed Producer whose cannabis has already been used in two published clinical trials.

A randomized, controlled trial of smoked cannabis for chronic neuropathic pain - this study found that a single inhalation of 25 mg of 9.4% THC herbal cannabis three times daily for five days reduced the intensity of pain, improved sleep quality, reduced anxiety and was well tolerated.ⁱ

The results of this study were used in the development of the Canadian Pain Society's Pharmacological management of chronic neuropathic pain: Revised consensus statement positioning medical cannabis as third line treatment for neuropathic pain.ⁱⁱ

A randomized controlled trial of herbal cannabis on chronic non-cancer pain - this was the first and largest study looking at the long term safety of medical cannabis use by patients suffering from chronic pain. Patients were given access to herbal cannabis containing 12.5% THC (CanniMed 12^.0) and were followed over one year. The researchers found that patients with chronic pain, who used cannabis daily for one year, when carefully monitored, did not have an increase in serious adverse events compared to pain patients who did not use cannabis. This study was published in the Journal of Pain.ⁱⁱⁱ

Note for editors:

CanniMed® Oils manufacturing visuals are available at the following coordinates: https://goo.gl/LtoKU1

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i} Ware, M.A., Wang, T., Shapiro, S., Robinson, A. and others. (2010) Smoked Cannabis for Chronic Pain: a Randomized Controlled Trial. Canadian Medical Association Journal (CMAJ). 182:E694-E701.

ⁱⁱ Moulin, D.E., Boulanger, A., Clark A.J., Dao, T. and others. (2014) Pharmacological Management of Chronic Neuropathic Pain: Revised Consensus Statement from the Canadian Pain Society. Pain Research and Management. Nov-Dec; 19(6): 328–335.

ⁱⁱⁱ Ware, M.A., Wang, T., Shapiro, S. and others. (2015) Cannabis for the Management of Pain: Assessment of Safety Study (COMPASS). The Journal of Pain. Vol 16. Nov 12. http://www.jpain.org/article/S1526-5900(15)00837-8/pdf

SOURCE Prairie Plant Systems Inc.

Video with caption: "Video: Footage of the CanniMed Oil manufacturing process". Video available at: http://stream1.newswire.ca/cgi-bin/playback.cgi?file=20160104_C6123_VIDEO_EN_591248.mp4&posterurl=http%3a%2f%2fphotos.newswire.ca%2fimages%2f20160104_C6123_PHOTO_EN_591248.jpg&order=1&jdd=20160112&cnum=C6123

Image with caption: "CanniMed Oils are now available for patient orders. (CNW Group/Prairie Plant Systems Inc.)". Image available at: http://photos.newswire.ca/images/download/20160104_C6123_PHOTO_EN_591142.jpg

or to schedule an interview, please contact: CanniMed Ltd., Phone: [phone], Email: [email protected]; Dara Willis, Dara Willis Communications, Mobile: [phone], Email: [email protected]