Hemp Oil

North Carolina House Passes Medical Marijuana Bill

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North Carolina House of Representatives approved a measure to allow the use of hemp oil manufactured from a marijuana plant to treat individuals with epilepsy.

The North Carolina House voted 111-2, to approve the use of medical oil made from a marijuana plant for treatment of patients with intractable epilepsy, a seizure disorder unresponsive to three or more treatment options. The bill, which cleared two committees in less than 24 hours, is known as Hope 4 Haley and Friends, named after Haley Ward, a 6-year old who suffers from the disorder.

House Bill 1220 would allow for the possession of cannabis extracts for individuals with intractable epilepsy who receive a recommendation from a neurologist, and who have obtained a registration card from the state’s Department of Health (DOH). The bill would allow physicians in the state to give these patients a Cannabidiol (CBD) oil called Charlotte’s Web, without being prosecuted for dispensing the drug.

When the bill passed the House committee on Wednesday, Stephen Carlin, who helped draft the bill, wept in hopes that his five-year old daughter, Zora, could be one of the thousands of people to gain access to the hemp oil extract that would help subdue her Dravet syndrome, a rare, incurable, debilitating epilepsy disorder. Carlin said that Zora has 40 to 60 seizures a day. To monitor his daughter, Carlin and his wife sleep in shifts.

The specific straight of marijuana being considered is high in CBD and low in tetrahydrocannabinol (THC), the psychoactive compound that is responsible for the high.

The US Food and Drug Administration (FDA) has selected three universities in the state – Wake Forest University, Duke University and the University of North Carolina at Chapel Hill – to conduct clinical trials of the CBD compound on seizure disorders.

The measure now moves to the Senate for approval.

Marijuana Research

30 Members of Congress Ask HHS to Facilitate Medical Marijuana Research

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On Tuesday, thirty members of Congress sent a letter to the Secretary of the Department of Health and Human Services (HHS), requesting that the government to ease the process of obtaining marijuana for research purposes.

The letter, led by Reps. Earl Blumenauer, H. Morgan Griffith, Dana Rohrabacher and Jan Schakowsky, was sent to HHS Secretary Sylvia Matthews Burwell, in support for increasing scientific research on the therapeutic risks and benefits of marijuana.

The letter comes shortly after the House voted to block the Drug Enforcement Administration (DEA) from interfering with medical marijuana operations that are legal under state laws. Additionally, just last week, physicians claimed that the agency had threatened to revoke their license because of their involvement in medical marijuana operations.

The letter asks the Burwell “take measures to ensure that any non-National Institutes of Health (NIH) funded researcher who has acquired necessary Food and Drug Administration (FDA), Institutional Review Board (IRB), Drug Enforcement Administration (DEA) and appropriate state and local authority approval be able to access marijuana for research at-cost without further review.”

Currently, 22 states and the District of Columbia have passed laws that legalize the use of medical marijuana. Even though almost half of the states in the US have legalized some form of medical marijuana, the federal government still labels marijuana as a Schedule I substance. Unlike any other drug classified as a Schedule I substance, marijuana requires an additional Public Health Service review for non NIH-funded protocols. Under the review process, the University of Mississippi contracted by the National Institute on Drug Abuse (NIDA) is the only source of marijuana that can be legally used for research.

“In light of the fact that substances like opioids and barbiturates have been researched and developed for human use, it would seem that we should investigate the legitimate medical uses of marijuana. We request that you review and revise the HHS Guidance to eliminate what we believe to be an unnecessary additional review process. NIDA should provide marijuana at-cost to all non-NIH funded marijuana research protocols that have successfully obtained necessary FDA, DEA, IRB and appropriate state and local authority approval,” the members of Congress write.

There is significant anecdotal evidence from patients, caregivers and physicians of marijuana’s therapeutic benefit for treatment of individuals suffering from cancer, epilepsy, glaucoma, anxiety, chronic pain and more. According to the letter, over one million Americans currently use marijuana for medicinal purposes at the recommendation of their doctor. Unfortunately, scientific research demonstrating these benefits has often been hampered by federal barriers. In the letter, the members of Congress say that more scientific information on the therapeutic risks and benefits of marijuana is needed.

 

Medical Marijuana Growers

Clark County Commissioners Approve 101 Medical Marijuana Operations

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More than 100 applicants from medical marijuana companies were granted approval by Commissioners in Nevada’s Clark County.

The Clark County Commission received 112 applications for medical marijuana establishments in three licensing categories: cultivation, production and laboratory.  With unanimous votes, commissioners approved 101 applications. Among the other eleven, five were rejected and six withdrew their applications.

The commission approved 58 permits for cultivation facilities, 38 permits for production facilities and five permits for laboratories for testing medical marijuana. There is no limit on how many cultivation sites are allowed, so the hearing lasted only seven hours. The applicants that were approved by the commissioners will still need to be approved by the state.

Two weeks ago, commissioners heard a first round of applications from businesses wanting to open medical marijuana dispensaries. However, due to the limit of dispensaries allowed the commission took much longer to review the 79 applications.  Additionally, the dispensaries must go through a state approval as well. License applications are being accepted until early August and will take up to 90 days to review them.

In 2013, the Nevada Legislature approved a bill allowing for medical marijuana dispensaries and related facilities to make sure that people who require medical marijuana could obtain the drug without breaking state law.

The Las Vegas Department of Planning will accept land use and licensing applications between July 8 and July 17, and mandated that anyone that submits and application must attend a workshop.

Epidiolex

GW Pharmaceuticals’ Epidiolex Demonstrates Positive Results in Patients with Hard-to-Treat Epilepsy

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Cannabis-based drug maker GW Pharmaceuticals plc recently announced that its experimental drug has produced promising results in a study of children with hard-to-treat epilepsy.

The company announced physician reports of efficacy and safety data on 27 children and young adults with treatment-resistant epilepsy who have been treated with GW’s investigational cannabidiol (CBD) product candidate, Epidiolex, for a period of 12 weeks. The treatment-resistant patients suffer from a range of epilepsies in which current anti-epileptic drugs have been unsuccessful in adequately controlling seizures, and include severe forms such as Dravet syndrome and Lennox-Gastaut syndrome.

Among the 27 patients who have been treated with Epidiolex for at least 12 weeks, two commenced treatment in 2013 and the remaining 25 patients commenced treatment in the first quarter of 2014. All of the patients were treated at New York University Langone Medical Center (NYU) or the University of California at San Francisco (UCSF).

“We are pleased to report preliminary data on Epidiolex which provides promising signals of efficacy in children with treatment-resistant epilepsy, including patients with Dravet syndrome. It is noteworthy that, of the patients who have responded to Epidiolex, a high proportion show a reduction in seizure frequency of greater than 50% and a portion of these patients were reported to be seizure-free at the end of 12 weeks of treatment,” said Justin Gover, GW’s Chief Executive Officer. “We believe that these signals of efficacy, together with the side effect profile observed to date, support GW’s decision to advance Epidiolex into a formal development program and we look forward to commencing a Phase 2/3 clinical trial of Epidiolex in Dravet syndrome in the second half of 2014.”

Among all patients, the mean overall reduction in seizure frequency as compared to baseline seizure frequency was 44 percent and median overall reduction in seizure frequency as compared to baseline seizure frequency was 42 percent. Forty-eight percent of all patients obtained at least a 50 percent reduction in seizure frequency as compared to baseline seizure frequency. Forty-one percent of all patients obtained at least a 70 percent reduction in seizure frequency as compared to baseline seizure frequency, and 22 percent of all patients obtained at least a 90 percent reduction in seizures. At the end of the 12 weeks, 15 percent of all patients were free of seizures.

“There remains an enormous unmet need in a range of pediatric and adult treatment-resistant epilepsy syndromes, which affect approximately 750,000 Americans. Some of the greatest needs are in children with severe epilepsy syndromes such as Dravet and Lennox-Gastaut, where frequent seizures often persist despite high doses of multiple anti-epileptic drugs,” said Orrin Devinsky, MD, Professor of Neurology, Neurosurgery, and Psychiatry at NYU School of Medicine, and Director, NYU Comprehensive Epilepsy Center. “The initial open-label study with Epidiolex has provided encouraging results. Some children have had marked reductions in their seizures and overall, the medication has been well tolerated.”

GW announced data for only convulsive seizures reported for each patient, the only type of seizures considered by the US Food and Drug Administration (FDA) in assessing primary efficacy for Dravet syndrome trials, in the nine patients with Dravet syndrome in the study. According to results, the mean reduction in seizure frequency as compared to baseline frequency was 52 percent and median reduction in seizure frequency as compared to baseline seizure frequency was 63 percent; 56 percent of Dravet patients obtained at least a 50 percent  reduction in seizure frequency as compared to baseline seizure frequency; 44 percent of Dravet patients obtained at least a 70 percent reduction in seizure frequency as compared to baseline seizure frequency; 33 percent of Dravet patients obtained at least a 90 percent reduction in seizure frequency as compared to baseline seizure frequency; and at the end of 12 weeks, 33 percent of Dravet patients were free of seizures.

Dpidiolex was granted orphan drug designation by the FDA, which may ease the drug’s path to market and offer the company additional exclusivity.

Following the announcement, GW’s shares increased as much as 17 percent.

Source: GW Pharmaceuticals plc

Last updated: 6/19/14; 10:30am EST