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GW Announces New Epidiolex® (CBD)
Positive Phase 3 Data in Dravet Syndrome
and Lennox-Gastaut Syndrome

At the 70th annual meeting of the American Epilepsy Society in Houston this week, GW Pharmaceuticals announced results of the first ever randomized, double-blind, placebo-controlled studies of CBD. The company’s proprietary CBD drug is called Epidiolex.
 
In the Dravet syndrome study, 43 percent of patients taking Epidiolex had a greater than or equal to 50 percent reduction in convulsive seizures compared to 27 percent of patients taking placebo. Seven patients taking Epidiolex achieved total seizure freedom. Click here to see data.
 
In the Lennox Gastaut syndrome study, 44.2 percent of Epidiolex patients had a greater than or equal to 50 percent reduction in drop seizures compared to 23.5 percent of patients taking placebo. Click here to see data.
 
“These placebo-controlled studies demonstrate that Epidiolex provides clinically meaningful reductions in seizure frequency together with an acceptable safety and tolerability profile,” stated Orrin Devinsky, MD, of New York University Langone Medical Center’s Comprehensive Epilepsy Center and Principal Investigator of the Dravet syndrome trial. “My colleagues and I are excited at the future prospect of prescribing an appropriately standardized and tested pharmaceutical formulation of cannabidiol.”
 
Posters presenting the data note that findings reported in these studies are specific to GW Pharmaceuticals’ formulation of cannabidiol and cannot be extrapolated to other CBD products.

As the chart above illustrates, having completed clinical trials with more than 1,500 patients, including expanded access trials for more than 1,000, GW plans to seek a New Drug Application (NDA) for FDA approval in a few months. If approved, GW will market Epidiolex under a new company name in the US: Greenwich Biosciences.
 
Read more about this here and here.

Disclosure: In August 2016, The Marijuana Report’s editor purchased GW Pharmaceuticals stock.
 
Maine Begins Recount on
Marijuana Legalization Vote

Maine was one of four states that legalized recreational pot via ballot initiatives in the presidential election last month. However, the Maine referendum passed by only 4,073 votes (381,692 to 377,619), according to unofficial results from the Secretary of State’s Office.
 
Legalization opponents immediately requested a recount to ensure the vote is accurate, given the negative impact of legalization on public health.
 
The recount began this week and is the first in Maine’s history. It is expected to cost $500,000 and take up to a month.
 
Read more here and here.
 
Naperville North H.S. Students Sickened After Eating Tainted Gummy Bears

More than a dozen students from Naperville North High School near Chicago were taken to the hospital yesterday after eating gummy bears. The students told police the gummy bears were infused with marijuana. Police confiscated the candy for testing.
 
The students experienced rapid heartbeat, dizziness, and dry mouth. The school’s Facebook page announced that late yesterday two students were in stable condition and being evaluated. All the others had been released from the hospital.
 
Read more here and here.
 
Oregon Revises Marijuana Rules
After Industry Backlash

The Oregon Health Authority bowed to industry pressure to loosen rules designed to protect public health after marijuana producers and processors complained the rules were producing a backlog that was emptying shelves and resulting in employee layoffs.

The new rules ease potency testing requirements and allow producers to test multiple strains in a single batch. Previously each strain had to be tested individually.

Oregon was the first state to require that both medical and recreational marijuana be tested for pesticides, a requirement the industry fought. That rule, however, held despite industry pressure to water it down or remove it. 

Since October, 307 tested marijuana samples contained either pesticides or residual solvents used in the extraction process.

Read more here.

The Marijuana Report is a weekly e-newsletter published by National Families in Action in partnership with SAM (Smart Approaches to Marijuana). Visit our website, The Marijuana Report.Org, to learn more about the marijuana story unfolding across the nation.
 
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About National Families in Action (NFIA)
NFIA consists of families, scientists, business leaders, physicians, addiction specialists, policymakers, and others committed to protecting children from addictive drugs. Our vision is:
  • Healthy, drug-free kids
  • Nurturing, addiction-free families
  • Scientifically accurate information and education
  • A nation free of Big Marijuana
  • Smart, safe, FDA-approved medicines developed from the cannabis plant (and other plants) 
  • Expanded access to medicines in FDA clinical trials for children with epilepsy 
About SAM (Smart Approaches to Marijuana)
SAM is a nonpartisan alliance of lawmakers, scientists and other concerned citizens who want to move beyond simplistic discussions of "incarceration versus legalization" when discussing marijuana use and instead focus on practical changes in marijuana policy that neither demonizes users nor legalizes the drug. SAM supports a treatment, health-first marijuana policy.  SAM has four main goals:
  • To inform public policy with the science of today's marijuana.
  • To reduce the unintended consequences of current marijuana policies, such as lifelong stigma due to arrest.
  • To prevent the establishment of "Big Marijuana" - and a 21st-Century tobacco industry that would market marijuana to children.
  • To promote research of marijuana's medical properties and produce, non-smoked, non-psychoactive pharmacy-attainable medications.
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