sativex

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U.S.: Former GW Pharmaceuticals Advisor Discusses Future of Medical Cannabis

DrEthanRusso[Ganjapreneur]

Cannabis business website Ganjapreneur has announced its latest podcast episode, which features prominent medical marijuana researcher Dr. Ethan Russo in a conversation about his research regarding the Endocannabinoid System — a unique system found in all vertebrates, including humans, which promotes homeostasis and a biological balance across bodily functions.

In the interview, Ganjapreneur podcast host Shango Los asks Dr. Russo about Endocannabinoid Deficiency (ECD) and the potential for it to be treated with cannabis. As Russo explains, ECD is just coming into general awareness now as a cause behind several conditions including Migraines, Fibromyalgia, Irritable Bowel Syndrome, Phantom Limb Pain, Infantile colic, Glaucoma, PTSD, Bipolar disease and others.

When used as a form of treatment, "A lot of what THC does is paralleled by the effects of... natural chemicals in the body that everyone has," Dr. Russo explained.

Before going public with his research, Dr. Russo worked for years as senior medical advisor for GW Pharmaceuticals; there, he oversaw three separate clinical trials for Sativex, one of the world's first cannabinoid-based medicines to be approved for public use.

Today, he is medical director at Phytecs, a company specializing in the production of cannabis-based treatments related to the endocannabinoid system. Due to legal complications and concerns over the federal legality of his work, Dr. Russo only began to speak publicly about his research earlier this year.

Chile: Housewife Billed As Latin America's First Legal Medical Marijuana Patient

Chile-CeceliaHayderMMJPatient

By Steve Elliott
Hemp News

A 48-year-old woman in Chile has become the first legal medicinal cannabis patient in Latin America after being granted special permission by the Institute for Public Health due to having both systemic lupus and breast cancer.

"I feel like I am burning up inside," Cecilia Hayder said, reports NBC News. "Everything hurts. I don't have the strength to take a step, and I often have to use a wheelchair. My body rejects opiates so cannabis is the only thing that works for me."

Heyder, a mother of two, will be treated with Sativex, extracted from cannabis, with equal amounts of tetrahydrocannabinol (THC) and cannabidiol (CBD). Sativex isn't considered to be psychoactive, as the CBD mediates the effects of the THC. Although she's already permitted to take Sativex, a new law will have to be rushed through Chile's Congress to allow the public health system to pay for it.

That process will take at least two more months; with Sativex costing more than $3,000 monthly, Heyder simply cannot afford the stuff without government help.

"I am very happy and grateful to the parliamentarians, she said. "But I don't see why my case had to become so emblematic for this to change. Too many people have suffered because of this taboo."

U.S.: Sativex Gets Fast Track Designation From FDA For Cancer Pain

SativexSpray

By Steve Elliott
Hemp News

Big Pharma continues its moves to take over the medical marijuana industry. GW Pharmaceuticals, a biopharmaceutical company based in the United Kingdom, on Monday announced the the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Sativex, an oral spray containing THC and CBD in a 50:50 ratio, for the treatment of pain in patients with advanced cancer.

Sativex is currently in Phase 3 clinical trials for this indication, according to a press release from GW Pharmaceuticals.

The FDA's Fast Track program facilitates the developmental process for drugs intended to treat serious or life-threatening conditions and that have the potential to address "unmet medical needs." A drug program with Fast Track status is given greater access to the FDA for the purpose of speeding up the drug's development, review and potential approval.

"The award of Fast Track designation for Sativex represents important recognition by the FDA of the potential of this medicine to address significant unmet needs in the treatment of cancer pain," said Justin Gover, CEO at GW Pharmaceuticals. "Sativex is the only non-opioid treatment currently in Phase 3 development for patients who do not respond to, or experience negative side effects with opioid medications.

"We are fully committed to delivering the first FDA-approved cannabinoid medicine for these patients who currently have nowhere else to turn," Gover said.

GW is developing Sativex in the U.S. in collaboration with Otsuka Pharmaceutical Co., Ltd.

France: Sativex Spray Approved After Ban Lifted On Marijuana Derived Medicines

SativexInHand

By Steve Elliott
Hemp News

The French Ministry of Health on Thursday announced that it has approved Sativex, a marijuana-based mouth spray, to be prescribed for medical reasons. Cannabis-derived medicines had been banned from the market in France until last June, when Health Minister Marisol Touraine passed a decree allowing the sale of such medications.

Thursday's announcement "is a step prior to the marketing of the product, which will take place at the initiative of the laboratory," the Ministry of Health announced, reports RT.com.

The British corporation GW Pharmaceuticals produces Sativex. The oral spray is expected to be available in France in 2015 for use against multiple sclerosis. It will be used for MS patients with severe muscle spasms who are resistant to other forms of treatment, the Health Ministry said.

Sativex is already available in most of Europe, including the United Kingdom, Germany, Spain and Italy.

In France, its use will be very strictly controlled and will only be prescribed by specialists such as neurologists. Patients will only be able to get one month's supply at the time, and will be required to renew their prescriptions every six months. The same basic rules are used with opiate medications in France.

Study: Marijuana Spray Doesn't Affect Mood or Cognition

SativexSpray

By Steve Elliott
Hemp News

Multiple sclerosis patients who use an oral spray containing cannabinoids showed no long-term cognitive impairment or changes in mood, according to a new study published by GW Pharmaceuticals, the giant British-based biopharmaceutical company.

The spray, sold under the brand name Sativex, is approved for use in Europe, Canada and Mexico to treat MS and cancer pain; it hasn't yet been approved for sale in the United States, reports Pat Anson at the American News Report.

Sativex is a 50/50 mix of the naturally occurring phytocannabinoids tetrahydrocannabinol (THC) and cannabidiol (CBD), both extracted from cannabis plants that GW Pharmaceuticals grows in the United Kingdom for that purpose.

GW Pharmaceuticals has applied to sell Sativex in the U.S., and hopes to get approval from the Food and Drug Administration (FDA) by the end of this year.

"We are pleased to report positive and wholly reassuring results from this 12-month placebo-controlled study in patients with MS spasticity," said Dr. Stephen Wright, research and development director at GW Pharmaceuticals.

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