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CBD

Epidiolex Weighs in at Schedule V

By | Cannabinoids, CBD, Conditions, Epilepsy, General Information, News, Research, Research Articles, Seizure Disorder
But CBD remains on Schedule I, due to its supposed abuse liability.  “DEA’s decision to move Epidiolex to Schedule V…  applies only to CBD products approved by the FDA. Other, non-FDA-approved CBD preparations remain in Schedule I,”  says GW Pharmaceuticals’ press release (excerpted below):

Product expected to be available within six weeks

GW Pharmaceuticals plc (Nasdaq: GWPH, “GW,” “the Company” or “the Group”), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, along with its U.S. subsidiary Greenwich Biosciences, announced today that EPIDIOLEX®(cannabidiol) oral solution has been transferred to Schedule V, the lowest restriction classification, by the U.S. Drug Enforcement Administration (DEA). EPIDIOLEX, which was approved by the U.S. Food and Drug Administration (FDA) on June 25, 2018 for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients two years of age or older, is the first prescription pharmaceutical formulation of highly-purified, plant-derived cannabidiol (CBD), a cannabinoid lacking the high associated with marijuana, and the first in a new category of anti-epileptic drugs (AEDs).

“We are pleased that the DEA has placed EPIDIOLEX in the lowest restriction Schedule, because it will help ensure that patients with LGS and Dravet syndrome, two of the most debilitating forms of epilepsy, can access this important new treatment option through their physicians,” said Justin Gover, GW’s Chief Executive Officer. “With this final step in the regulatory process completed, we are working hard to make EPIDIOLEX available within the next six weeks as we know there is excitement for a standardized version of cannabidiol that has undergone the rigor of controlled clinical trials and been approved by the FDA.”

With this decision, the product label for EPIDIOLEX will be finalized. The Company’s development program represents the only well-controlled clinical evaluation of a cannabinoid medication for patients with LGS and Dravet syndrome. Both diseases, which develop in childhood, are rare, severe forms of epilepsy that are notoriously treatment-resistant.[1],[2] Most patients with LGS and Dravet syndrome require multiple seizure medications and the majority are resistant to currently approved AEDs.2,[3],[4] The day-to-day impact of these conditions is significant with high rates of early mortality.[5],[6] The Company anticipates making EPIDIOLEX available within the next six weeks. Availability is primarily dependent on the time involved in obtaining the required Schedule V licenses for the U.S. distributor and importer.

Medicines in Schedule V have a proven medical use and low potential for abuse. DEA’s decision to move EPIDIOLEX to Schedule V was based on non-clinical and clinical data that evaluated the medicine’s potential for abuse and applies only to CBD products approved by the FDA. Other, non-FDA-approved CBD preparations remain in Schedule I. Some examples of Schedule V drugs are cough preparations such as Robitussin AC, and a number of commonly prescribed anti-epilepsy drugs such as VIMPAT (lacosamide), BRIVIACT (brivaracetam), and Lyrica (pregabalin).

The most common adverse reactions that occurred in EPIDIOLEX-treated patients were somnolence, decreased appetite, diarrhea, transaminase elevations, fatigue, malaise, and asthenia, rash, insomnia, sleep disorder and poor-quality sleep, and infections.  The medicine will be marketed in the United States by Greenwich Biosciences, the U.S. subsidiary of GW Pharmaceuticals plc. More information, including the final product label, can be found at Epidiolex.com. Read More

Cannabidiol Induces Programmed Cell Death in Breast Cancer Cells

By | Breast Cancer, CBD, Research Articles

Cannabidiol Induces Programmed Cell Death in Breast Cancer CellsA study by researchers at Harvard Medical School was published in Molecular Cancer Therapeutics in 2011 characterizing the mechanism underlying the antitumoral properties of cannabidiol (CBD). This study showed that CBD induced both apoptosis and autophagy-induced death in breast cancer cells and inhibited the survival of both estrogen receptor-positive and estrogen receptor-negative breast cancer cell lines. These data enhance the desirability of CBD as an anticancer agent, because they suggest that CBD preferentially kills breast cancer cells, while minimizing damage to normal breast tissue.
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Cannabidiol Inhibits Human Glioma Cell Migration

By | Brain Health, Cancer, CBD, Research Articles

CaCannabidiol Inhibits Human Glioma Cell MigrationIn 2005, the British Journal of Pharmacology published a study evaluating the ability of cannabidiol (CBD) to impair the migration of tumor cells and thus act as a potential antitumoral compound. The results of the study reinforce the evidence of antitumoral properties of CBD, demonstrating its ability to limit tumor invasion, although the mechanism of its pharmacological effects remains to be clarified. This antimigratory property, together with the known antiproliferative and apoptotic features of CBD, strengthen the evidence for its use as a potential antitumoral agent.
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Medical Cannabis Strain Content Satisfaction

By | CBD, Research Articles, THC, THCV

Medical Cannabis Strain Content Satisfaction

This study, published in the June 2014 issue of the Journal of Clinical Psychopharmacology, describes more than 100 patients reporting about the therapeutic satisfaction with their pharmaceutical-grade cannabis product. Furthermore, differences in subjective effects among the available strains are investigated. Read More

Cannabinoid Receptor Pharmacology

By | CBD, Endocannabinoid System, Research Articles, THC, THCV

Cannabinoid Receptor Pharmacology | Cannabinoid Receptor Agonists

Cannabis sativa is the source of a unique set of compounds known collectively as plant cannabinoids or phytocannabinoids. This review published in 2008 in the Journal of British Pharmacology focuses on the manner with which three of these compounds, (_)-trans-D9-tetrahydrocannabinol (D9-THC), (_)-cannabidiol (CBD) and (_)-trans-D9-tetrahydrocannabivarin (D9-THCV), interact with cannabinoid receptors CB1 and CB2. Read More

MS Spasticity, THC:CBD Cannabis Spray, And Driving

By | CBD, Driving, Multiple Sclerosis, Research Articles, THC

MS Spasticity, THC:CBD Cannabis Spray, And Driving | Cannabis and Multiple Sclerosis

Cannabis and Multiple Sclerosis: Is driving safe for MS patients who use cannabis for resistant spasticity? In this poster presentation by German neurologists they show that THC:CBD oromucosal spray (Sativex), when used for 4-6 weeks by patients with multiple sclerosis, did not harm driving skills. As a matter of fact, there was significant improvement in a motor reaction task test. Read More

Cannabidiol Inhibits Proliferation and Invasion in Glioma Cells

By | Brain Health, Cancer, CBD, Research Articles

Cannabidiol Inhibits Proliferation and Invasion in Glioma Cells | CBD Brain Cancer

This study out of Spain and published in October 2013, confirms the antiproliferative and antiinvasive effects of CBD in two different glioma cell lines. Interestingly, these effects can also be extended to glioma cells that are well known to be D9-THC-resistant. This data adds further insights into CBD antitumor action, showing its ability to influence multiple cellular targets in the two cell lines with partial overlap. Read More

Enhancing the Activity of Cannabidiol and Other Cannabinoids In Vitro

By | Cancer, CBD, Research Articles

Cannabis for Leukemia | Research on Cannabis and Cancer

The concomitant administration of various non-psychoactive plant cannabinoids demonstrates synergistic anti-cancer activity in human leukemia cells, according to preclinical trial data published online in the October 2013 journal Anticancer Research. They explored the activity of six cannabinoids, used both alone and in combination in leukemic cells. Cannabinoids were cytostatic and caused a simultaneous arrest at all phases of the cell cycle. Read More

The Role of Cannabinoids in Prostate Cancer

By | Cancer, CBD, Research Articles, THC

The Role of Cannabinoids in Prostate Cancer

From the Indian Journal of Urology in 2012 comes this information regarding cannabis and prostate cancer: ‘It is our conclusion that it would be of interest to conduct clinical trials involving medicinal cannabis or other cannabinoid agonists, comparing clinical markers such as PSA with controls, especially in men with bone metastatic prostate cancer, whom would not only benefit from the possible anti-androgenic effects of cannabinoids but also from analgesia of bone pain, improving quality of life, while reducing narcotic consumption and preventing opioid dependence.’ Read More