gw pharmaceuticals

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Study: Cannabis Component Reduces Seizures For Some Epilepsy Patients, According To Research

NYU Langone Center

By Michael Bachara
Hemp News

An oil derived from the cannabis plant sharply reduces violent seizures in young people according to a study published last Wednesday in the New England Journal of Medicine. The study focused on patients with Dravet syndrome, a severe type of epilepsy.

"This is the first solid, rigorously obtained scientific data that a marijuana compound is safe and effective for this problem," said Dr. Orrin Devinsky, a neurologist at New York University Langone Medical Center and primary author of the study.

U.S.: GW Pharma Moves To Monopolize CBD Market

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By Derrick Stanley
Hemp News

Bruce Barcott of Leafly has exposed some actions taken by GW Pharma (NASDAQ: GWPH) that seem to attempt to limit competition from suppliers of CBD.

Lobbyists have been engaged in several states by the company and its U.S. subsidiary, Greenwich BioSciences, companies which are both supporting legislation in South Dakota and Nebraska that would “effectively give GW/Greenwich a temporary monopoly on legal CBD products” in those states for its Epidiolex.

If given FDA approval, Epidiolex could be on the market in early 2018. Legislation advancing in both South Dakota and Nebraska suggests that CBD would be permitted only from FDA-approved providers.

Barcott says GW Pharma and Greenwich BioSciences have hired lobbyists in Arizona, Florida, Idaho, Minnesota, Nebraska, South Dakota, Washington and Wisconsin and possibly in California. Barcott attempted to contact GW Pharma for comment but has not yet received a reply. Should GW Pharma succeed in stifling competition, it could have a serious impact on hopeful in-state poducers of CBD, as well as companies both foreign and domestic who extract CBD from industrial hemp.

Great Britain: Marijuana Extract Proven To Treat Rare Forms Of Epilepsy

A form of marijuana extract has again proven to be an effective treatment for several different types of epilepsy.

By Derrick Stanley
Hemp News

A pharmaceutical-grade form of marijuana extract has again proven to be an effective treatment for several different types of epilepsy.

The British company GW Pharmaceuticals has released successful results from the latest clinical trial of Epidiolex, a form of CBD-rich medication, Forbes reported.

It was the second trial for a rare type of epilepsy called Lennox Gastaut Dyndrome. Epidiolex was given to 86 patients who suffer from the disorder, while 85 patients received a placebo medication. Patients given the Epidiolex saw their seizures reduce by 44%, compared to a 22% reduction for those in placebo.

“Between the plant itself and the processing steps which are being taken, the product ends up being pure CBD,” said GW’s chief executive Justin Gower to Forbes.

GW Pharmaceuticals plans to file for FDA approval in the first half of 2017, although many similar CBD-based formulations are already available in states with legal medical marijuana laws, such as California and Colorado.

Global: Marijuana-Based Drug Found To Reduce Epileptic Seizures

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By Steve Elliott
Hemp News

The first major clinical trial of an experimental drug derived from marijuana has shown that Epidiolex reduces epileptic seizures, the product's developer announced on Monday.

The shares of Big Pharma giant GW Pharmaceuticals more than doubled on Monday after the announcement.

GW said Epidiolex achieved the main goal of the trial, reducing convulsive seizures when compared with a placebo in patients with Dravet syndrome, a rare, severe form of epilepsy, reports Andrew Pollack at The New York Times.

If Epidiolex wins regulatory approval, as expected, it would be the first prescription drug that is extracted from marijuana. Marinol (Dronabinol), the THC capsules prescribed for nausea and appetite, use synthetic rather than plant-derived THC.

Epidiolex is a liquid containing cannabidiol (CBD), a non-psychoactive component of cannabis.

As many as one-third of the nearly 500,000 American children with epilepsy aren't sufficiently helped by existing Big Pharma drugs, according to GW. Parents of these children have, in desperation, tried medicinal cannabis extracts prepared by medical marijuana dispensaries.

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.

U.S.: Medical Marijuana Advocacy Group Runs Ad In USA Today Announcing DC Conference

ASAConferenceAdUSAToday-MedicalMarijuanaLawsAreNotChangingThemselvesWeAre

3rd Annual Conference in Washington DC, March 27-31

Medical marijuana advocacy group Americans for Safe Access (ASA) formally announced its third annual Unity Conference, "Wellness is Winning: Advancing Evidence Based Medical Cannabis Policy," by running an ad in USA Today.

The conference, which is being held in Washington, D.C. on March 27-31, 2015, will highlight medical and legal experts, policymakers, and a wide array of workshops and panels focusing on scientific research, strategic planning, and skills building. On Tuesday, March 31st, ASA will host a press conference at 11am, followed by Congressional lobbying visits by hundreds of patient advocates.

What: National Unity Conference: "Wellness is Winning: Advancing Evidence Based Medical Cannabis Policy"
When: March 27-31, 2015, including a press conference at 11 am on March 31
Where: Loews Madison Hotel, 1177 15th Street NW, Washington, DC 20005

The quarter-page USA Today ad, which ran all last week in the newspaper's NFL Super Bowl Preview publication, appeared on news stands across the country. This week, a digital version of the ad is running online for millions of Internet viewers.

Sponsors of the ad include the American Herbal Products Association, Cannabis Training Institute, Patient Focused Certification, and OrganiCann.

GMO Weed? Connections Alleged Between Uruguay Marijuana Legalization, Monsanto and Soros

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By Steve Elliott
Hemp News

Uruguay earlier this year became the first nation in the world to legalize the cultivation, sale and possession of marijuana. Now one German researcher is alleging that billionaire speculator George Soros supported legalization in that South American country as part of a plan for corporate agribusiness giant Monsanto to move into the cannabis trade.

Engdahl alleges, on the website of the European Coalition for Just and Effective Drug Policies (ENCOD) that Monsanto is already quietly at work on a project to patent a genetically modified cannabis plant in Uruguay. Since Soros played a pivotal role in Uruguay's legalization drive (he sits on the board of the Drug Policy Alliance), and also owns considerable Monsanto stock, Engdahl believes those two things are connected, and they point towards Monsanto involvement.

Soros' Open Society organization distributed $34 million last year, according to Engdahl, nearly $3.5 million of which was dedicated to marijuana legalization. Open Society funded the group Regulacion Responsable ("Responsible Control") in Uruguay; the group ran a nationwide advertising campaign for the successful legalization drive.

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.

U.K.: Study Shows Marijuana Compounds Can Kill Cancer Cells

CannabisInLaboratory

By Steve Elliott
Hemp News

A scientist at the University of London's St. George School of Medicine has found that cannabinoids from marijuana can kill cancerous cells found in people with leukemia, a form of cancer which kills 24,000 people each year in the United States.

"Cannabinoids have a complex action; it hits a number of important processes that cancers need to survive," said study author Dr. Wai Liu, an oncologist, reports Matt Ferner at The Huffington Post. "For that reason, it has really good potential over other drugs that only have one function.

"I am impressed by its activity profile, and feel it has a great future, especially if used with standard chemotherapies," Dr. Liu said.

The study was recently published in the journal Anticancer Research. It was funded by GW Pharmaceuticals, which makes a marijuana-derived nasal spray, Sativex, that is used to treat spasticity caused by multiple sclerosis.

The study examined six different non-psychoactive cannabinoids, which unlike THC, don't get you high. The cannabinoids were examined alone and in combination; they displayed "a diverse range of therapeutic qualities" that "target and switch off" pathways, preventing cancer from growing, according to U.S. News and World Report.

U.K.: GW Pharmaceuticals Begins Phase I Clinical Trials of Natural Cannabinoid For Epilepsy

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By Steve Elliott
Hemp News

London-based GW Pharmaceuticals on Wednesday announced that it has started a Phase 1 clinical trial of a natural, plant-derived cannabinoid, GWP42006, for the treatment of epilepsy.

GW has been performing pre-clinical cannabinoid research in the field of epilepsy for the past five years in collaboration with the University of Reading in the United Kingdom. The research, according to GW, "has led to the emergence of a number of promising cannabinoid therapeutic candidates showing anti-epileptic effects."

GWP42006, seen by GW as one of the most promising of these candidates, is a non-psychoactive cannabinoid extracted from specific strains of the cannabis plant. The cannabinoid has shown the ability to treat seizures in pre-clinical models of epilepsy, with, according to the company, "significantly fewer side effects that currently approved anti-epileptic drugs."

"We are pleased to have advanced GWP42006 to first dose in man, a significant milestone in the development of this novel product candidate," said Dr. Stephen Wright, director of research and development at GW. "The decision to progress into Phase I follows several years of highly promising pre-clinical research."

"We believe that GWP42006 has the potential to become an important advance in the treatment of epilepsy, a condition for which there remains a substantial unmet medical need," Dr. Wright said.

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.

France: GW Pharmaceuticals Applies To Expand Sativex Approval

GWPharmaceuticalsCannabisSativa

By Steve Elliott
Hemp News

Big Pharma giant GW Pharmaceuticals has submitted an application seeking to expand marketing authorization for Sativex into France for the treatment of spasticity due to multiple sclerosis (MS).

Sativex, an oral spray containing a 50:50 mixture of the cannabinoids THC (tetrahydrocannabinol) and CBD (cannabidiol), is already approved as a treatment for MS spasticity in 21 countries, including 17 countries in Europe. The medicine is available on prescription in the United Kingdom, Spain, Germany, Canada, Denmark, Norway, Israel, Austria, Poland, Sweden and Italy, with launches in preparation in eight more European countries, as well as Australia and New Zealand, according to GW.

"Sativex meets a significant unmet medical need for patients with multiple sclerosis and we look forward to working with the French authorities so as to allow this important medicine to be made available in France," said Justin Gover, chief executive officer at GW Pharmaceuticals.

"The submission of this MRP for Sativex in France builds on the recent commercial launch in Italy and continues the momentum of expanding Sativex availability throughout Europe," Gover said. "We see this growth as important validation of patient and physician acceptance of Sativex in meeting the needs of people with multiple sclerosis."

GW Pharmaceuticals Announces Sativex® Now Available In Italy

SativexInHand

By Steve Elliott
Hemp News

Sativex, the 50:50 combination of THC (tetrahydrocannabinol) and CBD (cannabidiol) in oral spray form, made by GW Pharmaceuticals, is now available in Italy, GW's partner company Almirall announced on Monday.

Sativex is available in Italy as a prescription medicine for treatment of moderate to severe spasticity in multiple sclerosis (MS) patients who have not responded to other anti-spasticity medicines. The launch follows full marketing authorization for Sativex by Italian health authorities in May.

The medication is reimbursed by Italian authorities as a Class H (hospital dispensed) medicine. The reimbursed price of Sativex granted by government authorities in Italy is consistent with the reimbursed price of Sativex in Spain, according to GW.

"As one of the largest markets in Europe, the launch of Sativex in Italy is a key milestone in the commercialization of this important new medicine," said Justin Gover, chief executive officer of GW. "Italy represents yet another addition to the growing number of countries in Europe in which Sativex is now available to treat MS spasticity, a particularly debilitating symptom of MS that is not adequately treated with currently available medications.

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