SAN DIEGO, Aug. 1, 2012 /PRNewswire/ -- Medical Marijuana Inc. (OTC: MJNA), a leading hemp industry innovator, is pleased to provide an update on the efforts of Canipa Holdings in regards to European Union marketing approvals for MJNA Portfolio Products including the Dixie X Brand and CanChew gum.
Approval Process
Canipa Holdings is currently working with European Health Authorities and their Governmental counterparts to obtain marketing approvals for the Dixie X and CanChew gum hemp-based, CBD-infused products. We expect preliminary approval in 60 days and final approval 30 days after. Once approved, these products will be sold "over-the-counter" throughoutRomania and the remaining 26 European Union Member Countries.
Pending Clinical Studies
Simultaneous to the marketing approvals, MJNA and Canipa Holdings are working with authorities to provide European FDA-level clinical studies. While there have been numerous, positive studies on the effects of Cannabinoids (CBD's), the Company's specific CBD-infused products will be studied by selected EU medical universities. Initially it is anticipated that the studies will prove the safety and efficacy of these products in the treatment of chronic pain.
Further clinical trials will be commissioned to study the effect of the CBD-infused products on muscle spasticity and nausea. Muscle spasticity, which affects many spinal cord injury and neuro-degenerative patients (such as Multiple Sclerosis) can create pain through nerve entrapment. Nausea and vomiting are common symptoms of cancer chemotherapy patients.
The goal of the clinical trials will be to make formal European medical claims as to the effectiveness of CBD-infused Dixie X and CanChew gum in the treatment of chronic pain, muscle spasticity and nausea. Then to have the products approved as a doctors prescribed medication and therefore qualify for insurance reimbursement.
Pain Management Problem
MJNA has identified a growing problem in the area of pain management. To date, there have been few new breakthroughs since the introduction of opioids (morphine) in the 1950's. The new CBD-infused products have the potential to provide a certain degree of pain relief via potentially more natural means (whole hemp plant extracts and compounds) than with traditional pharmaceutical medications (where portions of plants, known as "active components" are isolated or chemically synthesized).
Although various pharmaceutical companies have developed new pain medication drugs in recent years, they generally fall under the category: non-steroidal, anti-inflammatory drugs (NSAIDs). Many of these medications have been found to have harmful side-effects. As an example, Pfizer's Celebrex was at one time a huge selling drug however, The National Cancer Institute, which was conducting a study for Pfizer, suspended use of the drug and terminated their study.
The findings were that patients taking 400mg to 800mg of Celebrex daily had a 2.5 times greater risk of major heart problems than those who were taking placebos (look-alike pills with no active ingredients). It is still on the US market but with a strong "black box' warning from the FDA. Pfizer's Bextra product was pulled from European markets – again due to safety concerns.
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