Medical Marijuana Inc. and Canipa Holdings Drive Dixie X and CanChew Gum Toward EU Marketing Approval And Clinical Development
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.
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” throughout Romania 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. Source: http://www.painstudy.com/PainDrugs/p44.htm
Europe, US, Canada Suspend Certain Pain Management Medications
Recently the European Medicines Agency has recommended a suspension of all buflomedil-containing medicines due to safety concerns. Some pain medications contain buflomedil, a vaso-active agent, which has an effect on circulation.
The opioid, Hydrocodone, is no longer available in many European countries, again due to certain safety concerns. The list includes: Austria, Belgium, Germany, Sweden, the Netherlands and the U.K. Although available on the US medical markets as a Schedule II drug, nearly 88% of hydrocodone based medications have been removed from the US marketplace. Oxycodone, another opioid, has also been removed from European and US markets. Source: http://www.fiercepharma.com/press-releases/fda-prompts-companies-remove-certain-unapproved-oxycodone-products-market .
Oxycontin has been removed from Canadian markets, source: http://www.torontosun.com/2012/02/29/oxycontin-removed-from-canadian-market.
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.
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. Source: http://anthonyvieira.typepad.com/ and http://en.wikipedia.org/wiki/Merck_%26_Co.
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.
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 Europe is 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.
“We view ourselves as having significant opportunities to launch our revolutionary new whole hemp plant extract, CBD-infused products to the over-the-counter market,” said Michael Llamas, President, Medical Marijuana Inc.
“In Europe we are undertaking studies in an attempt to provide sufficient clinical data to justify our products’ abilities to make certain medical claims. Our initial aim lies in chronic pain management, then in the treatment of muscular spasticity plus nausea and vomiting. Our success with the European trials will determine our course of additional clinical activities in the US marketplace. Nonetheless, our products are currently available in the Colorado and September 15(th) will be available to over-the-counter consumers on a nearly worldwide basis for general health and wellness benefits.”
Mr. Llamas went on further to state: “With many pain medications having recently been taken off the European markets, plus differing standards of care – there appears to be significant gaps in European pain management. Our revolutionary new products may be able to fill a few of these gaps and provide improved quality of life for those individuals. We look forward to the future and are extremely pleased with our European efforts to date. We appreciate the continued support of our team and shareholders.”
About Medical Marijuana, Inc.
Our mission is to be the premier cannabis and hemp industry innovators, leveraging our team of professionals to source, evaluate and purchase value-added companies and products, while allowing them to keep their integrity and entrepreneurial spirit. We strive to create awareness within our industry, develop environmentally friendly, economically sustainable businesses, while increasing shareholder value.
Medical Marijuana Inc. does not grow, sell or distribute any substances that violate United States Law or the controlled substance act.
For more information, please visit the company’s website at: www.MedicalMarijuanaInc.com
FOOD AND DRUG ADMINISTRATION (FDA) DISCLOSURE
These statements have not been evaluated by the Food and Drug Administration (FDA).
These products and statements are not intended to diagnose, treat, cure, or prevent any disease.
This press release may contain certain forward-looking statements and information, as defined within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and is subject to the Safe Harbor created by those sections. This material contains statements about expected future events and/or financial results that are forward-looking in nature and subject to risks and uncertainties. Such forward-looking statements by definition involve risks, uncertainties and other factors, which may cause the actual results, performance or achievements of Medical Marijuana, Inc. to be materially different from the statements made herein.
Medical Marijuana, Inc.
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SOURCE Medical Marijuana Inc.