{"id":3942,"date":"2012-08-01T22:45:07","date_gmt":"2012-08-01T22:45:07","guid":{"rendered":"http:\/\/www.medicalmarijuanainc.com\/?p=4257"},"modified":"2012-08-01T22:45:07","modified_gmt":"2012-08-01T22:45:07","slug":"medical-marijuana-inc-s-canipa-holdings-drive-dixie-x-and-canchew-gum-toward-eu-marketing-approval-and-clinical-development","status":"publish","type":"post","link":"https:\/\/medicalmarijuanainc.com\/2012\/08\/01\/medical-marijuana-inc-s-canipa-holdings-drive-dixie-x-and-canchew-gum-toward-eu-marketing-approval-and-clinical-development\/","title":{"rendered":"Medical Marijuana Inc.\u2019s Canipa Holdings Drive Dixie X and CanChew Gum Toward EU Marketing Approval And Clinical Development"},"content":{"rendered":"

SAN DIEGO, August 1, 2012 \/PRNewswire\/ — Medical Marijuana Inc.<\/a> (OTC: MJNA)<\/strong> 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<\/a> Portfolio Products including the Dixie X Brand<\/a> and CanChew gum<\/a>.<\/p>\n

Approval Process<\/strong><\/p>\n

Canipa Holdings is currently working with European Health Authorities and their Governmental counterparts to obtain marketing approvals for the Dixie X<\/a> and\u00a0CanChew gum hemp-based<\/a>, CBD-infused products. We expect preliminary approval in 60 days and final approval 30 days after. Once approved, these products will be sold \u201cover-the-counter\u201d throughoutRomania and the remaining 26 European Union Member Countries.<\/p>\n

Pending Clinical Studies<\/strong><\/p>\n

Simultaneous to the marketing approvals, MJNA<\/a> 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\u2019s), the Company\u2019s 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.<\/p>\n

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.<\/p>\n

The goal of the clinical trials will be to make formal European medical claims as to the effectiveness of CBD-infused Dixie X<\/a> and CanChew gum<\/a> 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.<\/p>\n

Pain Management Problem<\/strong><\/p>\n

MJNA<\/a> 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\u2019s.\u00a0 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 \u201cactive components\u201d are isolated or chemically synthesized).<\/p>\n

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).\u00a0 Many of these medications have been found to have harmful side-effects.\u00a0 As an example, Pfizer\u2019s 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.\u00a0 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).\u00a0 It is still on the USmarket but with a strong \u201cblack box\u2019 warning from the FDA.\u00a0 Pfizer\u2019s Bextra product was pulled from European markets \u2013 again due to safety concerns.\u00a0 Source: http:\/\/www.painstudy.com\/PainDrugs\/p44.htm<\/a><\/p>\n

Europe, US, Canada Suspend Certain Pain Management Medications<\/strong><\/p>\n

Recently the European Medicines Agency has recommended a suspension of all buflomedil-containing medicines due to safety concerns.\u00a0 Some pain medications contain buflomedil, a vaso-active agent, which has an effect on circulation.<\/p>\n

The opioid, Hydrocodone, is no longer available in many European countries, again due to certain safety concerns.\u00a0 The list includes: Austria, Belgium, Germany, Sweden, the Netherlandsand the U.K.\u00a0 Although available on the USmedical markets as a Schedule II drug, nearly 88% of hydrocodone based medications have been removed from the USmarketplace.\u00a0 Oxycodone, another opioid, has also been removed from European and US markets.\u00a0 Source:http:\/\/www.fiercepharma.com\/press-releases\/fda-prompts-companies-remove-certain-unapproved-oxycodone-products-market<\/a> .<\/p>\n

Oxycontin has been removed from Canadian markets, source: http:\/\/www.torontosun.com\/2012\/02\/29\/oxycontin-removed-from-canadian-market<\/a>.<\/p>\n

OxyContin, a schedule II opioid pain reliever introduced in 1996 which was more widely abused after its introduction that any prescription drug in the past 20 years.\u00a0\u00a0<\/span><\/p>\n

Pain medications Vioxx and Tylenol have recently been associated with liver damage and pharmaceutical manufacturer Merck made a global settlement of $4.85 billion in regards to wrongful death cases filed against it for its pain medication drug: Vioxx.\u00a0 Source: http:\/\/anthonyvieira.typepad.com\/<\/a>\u00a0 andhttp:\/\/en.wikipedia.org\/wiki\/Merck_%26_Co.<\/a><\/p>\n

Market Size<\/strong><\/p>\n

The market size for pain management is large and growing. In 2009, the global pain relief market generated revenues in excess of $50 billion. It is reported that currently 86 million Americans suffer from some sort of chronic pain, including 11 million people that claim their pain to be a significant disability. In a University of Oslo, Norway survey it was determined that approximately 19% of all European adults suffered from chronic pain that was of an intensity that seriously affected their social and working life.<\/p>\n

In that same University of Oslo study, it was determined that one-third of the sufferers were taking OTC treatments, two-thirds were taking prescription medicines and fully one-third of chronic pain sufferers were not being treated at all. Pain treatment in Europeis a large multi-billion dollar business. With the withdrawal of certain types of pain medications in the EU, a significant opportunity exists to fill the gap.<\/p>\n