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WASHINGTON, DC – Despite the U.S. government's best efforts to brand cannabis as an addictive drug with no medical value, a British pharmaceutical company is the latest in an ever growing field of medical professionals and researchers to find substantial value in a plant that is once again gaining world-wide acceptance for its therapeutic value.
Even as the Feds continue to wage war against state-sanctioned medical marijuana programs, landmark trials are being conducted which could see medicines derived from or inspired by the cannabis plant itself making their way to American pharmacy shelves.
Sativex is a cannabis-based spray, and has already been approved in several countries. (image courtesy GW Pharmaceuticals)
GW Pharmaceuticals of Britain has developed a mouth spray called Sativex that contains marijuana's two best known psychoactive ingredients, Delta-9 THC and cannabinoids.
GW Pharmaceuticals hopes to see FDA approval of Sativex by the end of 2013. The company is in advanced clinical trials to the get the spray approved in the United States as treatment for severe cancer pain.
To date, GW has completed clinical trials in over 3,000 patients, including over 20 Phase II and Phase III trials. These trials are conducted around the world and have included patients with a range of different medical conditions, including multiple sclerosis, cancer pain, neuropathic pain, and rheumatoid arthritis.
The drug is already approved in Canada, New Zealand, and eight European countries, including the United Kingdom, Czech Republic, Germany, Spain, Denmark and Sweden for relieving muscle spasms for patients with multiple sclerosis.
According to GW Pharmaceuticals, side effects for Sativex include dizziness, which occurs mainly in the first few weeks of treatment, and fatigue. These reactions are usually mild to moderate and improve within a few days even if treatment is continued.
There is no evidence to suggest that Sativex produces a 'high' comparable to recreational cannabis.
Possessing marijuana is still illegal in the United Kingdom, but about a decade ago GW Pharma's founder, Dr Geoffrey Guy, received permission to grow it to develop a prescription drug.
Coming soon to a pharmacy near you? GW Pharmaceuticals hopes to receive FDA approval for Sativex. (image courtesy GW Pharmaceuticals)
Coming soon to a pharmacy near you? GW Pharmaceuticals hopes to receive FDA approval for Sativex. (image courtesy GW Pharmaceuticals)
GW's cannabis plants are grown under computer-controlled conditions in secure glasshouses at a secret location in the UK. GW has developed a highly sophisticated cultivation process to ensure plant material grown is of sufficient quality and consistency to be suitable for incorporation into pharmaceutical products.
Strict procedures are followed to ensure non-contamination by chemicals, infestation or fungal growth, consistency of content, methods of harvest, drying, primary extraction, storage and onward consignment. Temperature, humidity, total light and photoperiod are all controlled by computer.
In the United States, marijuana remains within the strictest categorization of controlled substances, alongside heroin and LSD. The Department of Justice's Drug Enforcement Administration shot down a petition to reclassify marijuana as a drug with important medicinal properties in July 2011, citing that it has "no accepted medical use."
Try telling that to GW Pharmaceuticals, and the US Patent Office, who in April 2011 issued a notice of allowance for a patent, which protects the use of Sativex as a treatment for cancer pain, providing an exclusivity period until April 2025.
Reference:
Contributed by Sativa Galore on January 23, 2012.
Medical Marijuana News
Even as the Feds continue to wage war against state-sanctioned medical marijuana programs, landmark trials are being conducted which could see medicines derived from or inspired by the cannabis plant itself making their way to American pharmacy shelves.
Sativex is a cannabis-based spray, and has already been approved in several countries. (image courtesy GW Pharmaceuticals)
GW Pharmaceuticals of Britain has developed a mouth spray called Sativex that contains marijuana's two best known psychoactive ingredients, Delta-9 THC and cannabinoids.
GW Pharmaceuticals hopes to see FDA approval of Sativex by the end of 2013. The company is in advanced clinical trials to the get the spray approved in the United States as treatment for severe cancer pain.
To date, GW has completed clinical trials in over 3,000 patients, including over 20 Phase II and Phase III trials. These trials are conducted around the world and have included patients with a range of different medical conditions, including multiple sclerosis, cancer pain, neuropathic pain, and rheumatoid arthritis.
The drug is already approved in Canada, New Zealand, and eight European countries, including the United Kingdom, Czech Republic, Germany, Spain, Denmark and Sweden for relieving muscle spasms for patients with multiple sclerosis.
According to GW Pharmaceuticals, side effects for Sativex include dizziness, which occurs mainly in the first few weeks of treatment, and fatigue. These reactions are usually mild to moderate and improve within a few days even if treatment is continued.
There is no evidence to suggest that Sativex produces a 'high' comparable to recreational cannabis.
Possessing marijuana is still illegal in the United Kingdom, but about a decade ago GW Pharma's founder, Dr Geoffrey Guy, received permission to grow it to develop a prescription drug.
Coming soon to a pharmacy near you? GW Pharmaceuticals hopes to receive FDA approval for Sativex. (image courtesy GW Pharmaceuticals)
Coming soon to a pharmacy near you? GW Pharmaceuticals hopes to receive FDA approval for Sativex. (image courtesy GW Pharmaceuticals)
GW's cannabis plants are grown under computer-controlled conditions in secure glasshouses at a secret location in the UK. GW has developed a highly sophisticated cultivation process to ensure plant material grown is of sufficient quality and consistency to be suitable for incorporation into pharmaceutical products.
Strict procedures are followed to ensure non-contamination by chemicals, infestation or fungal growth, consistency of content, methods of harvest, drying, primary extraction, storage and onward consignment. Temperature, humidity, total light and photoperiod are all controlled by computer.
In the United States, marijuana remains within the strictest categorization of controlled substances, alongside heroin and LSD. The Department of Justice's Drug Enforcement Administration shot down a petition to reclassify marijuana as a drug with important medicinal properties in July 2011, citing that it has "no accepted medical use."
Try telling that to GW Pharmaceuticals, and the US Patent Office, who in April 2011 issued a notice of allowance for a patent, which protects the use of Sativex as a treatment for cancer pain, providing an exclusivity period until April 2025.
Reference:
Contributed by Sativa Galore on January 23, 2012.
Medical Marijuana News
