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Research Articles

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

Russo’s Grand Unified Theory

By | Alzheimer's Disease, Brain Trauma, Cancer, Conditions, Epilepsy, News, Parkinson's, Research, Research Articles

Ethan Russo forwards his paper, Grand Unified Theory (GUT): The Endcannabinoid System, Cannabis and the Microbiome just published in Frontiers of Integrative Neuroscience. Russo notes:

“This article addresses five critical areas of clinical neurology practice wherein conventional medicine has fallen short: epilepsy, brain tumors, Parkinson disease, Alzheimer disease, traumatic brain injury (TBI)/chronic traumatic encephalopathy (CTE), and how cannabis-based treatment and nutritional approaches with prebiotics and probiotics may provide more effective treatment.”

The paper, which will be the basis of Russo’s talk at the CannMed conference in LA October 23, begins with this overview:

Neurological therapeutics have been hampered by its inability to advance beyond symptomatic treatment of neurodegenerative disorders into the realm of actual palliation, arrest or reversal of the attendant pathological processes. While cannabis-based medicines have demonstrated safety, efficacy and consistency sufficient for regulatory approval in spasticity in multiple sclerosis (MS), and in Dravet and Lennox-Gastaut Syndromes (LGS), many therapeutic challenges remain. This review will examine the intriguing promise that recent discoveries regarding cannabis-based medicines offer to neurological therapeutics by incorporating the neutral phytocannabinoids tetrahydrocannabinol (THC), cannabidiol (CBD), their acidic precursors, tetrahydrocannabinolic acid (THCA) and cannabidiolic acid (CBDA), and cannabis terpenoids in the putative treatment of five syndromes, currently labeled recalcitrant to therapeutic success, and wherein improved pharmacological intervention is required: intractable epilepsy, brain tumors, Parkinson disease (PD), Alzheimer disease (AD) and traumatic brain injury (TBI)/chronic traumatic encephalopathy (CTE). Current basic science and clinical investigations support the safety and efficacy of such interventions in treatment of these currently intractable conditions, that in some cases share pathological processes, and the plausibility of interventions that harness endocannabinoid mechanisms, whether mediated via direct activity on CB1 and CB2(tetrahydrocannabinol, THC, caryophyllene), peroxisome proliferator-activated receptor-gamma (PPARγ; THCA), 5-HT1A (CBD, CBDA) or even nutritional approaches utilizing prebiotics and probiotics. The inherent polypharmaceutical properties of cannabis botanicals offer distinct advantages over the current single-target pharmaceutical model and portend to revolutionize neurological treatment into a new reality of effective interventional and even preventative treatment. Read More

Use of Prescription Pain Medications Among Medical Cannabis Patients

By | Opioids, Pain, Research Articles

Use of Prescription Pain Medications Among Medical Cannabis PatientsIn 2015, researchers at the University of Michigan published the first systematic comparison among medical cannabis users who use and do not use prescription pain medications (PPMs). PPM users and nonusers did not exhibit any difference in either lifetime or past-3-month use of other drugs, including cocaine, sedatives, street opioids, and amphetamines. PPM users rated the efficacy of cannabis higher than PPM for pain management and indicated a strong desire to reduce PPM usage. Longitudinal study designs are needed to better understand the trajectories of alcohol and other drug involvement over time among medical cannabis users. Read More

Use and Effects of Cannabinoids in Military Veterans with PTSD

By | PTSD, Research Articles

Use and Effects of Cannabinoids in Military Veterans with PTSD In the United States, post traumatic stress disorder (PTSD) is diagnosed in approximately 5.2 million people annually, and these people suffer a wide range of symptoms. A comprehensive literature search on PTSD and cannabis covering the period January 1, 1995, to October 1, 2014 was conducted. While further research into cannabinoid treatment effects on PTSD symptoms is required, the evaluated evidence indicates that substantial numbers of military veterans with PTSD use cannabis or derivative products to control PTSD symptoms, with some patients reporting benefits in terms of reduced anxiety and insomnia and improved coping ability. Read More

Treating Adult ADHD with Cannabis

By | ADHD, Research Articles

Treating Adult ADHD with CannabisThe medical certificates of 30 patients with adult ADHD, who were granted approval by the German Health Ministry to use cannabis flowers between 2012 and 2014, were analysed with regard to course of disease, previous treatment efforts, and effects of self-medication with cannabis or therapy with cannabis-based medications. For adult patients with ADHD, who experience side effects or do not profit from standard medication, cannabis may be an effective and well-tolerated alternative. Read More

Cannabinoids and Liver Cancer

By | Cancer, Research Articles

Cannabinoids and Liver CancerHepatocellular carcinoma (HCC) is the leading cause of cancer‐associated mortality worldwide; however, only limited therapeutic treatments are currently available. The present study aimed to investigate the effects of cannabinoids as novel therapeutic targets in HCC. In addition, the mechanism underlying the effects of a synthetic cannabinoid, WIN55, 212‐2, on the BEL7402 HCC cell line was investigated. These results provided a basis for the application of WIN in the treatment of HCC. Read More

Cannabinoids and Epilepsy

By | Epilepsy, Research Articles, Seizure Disorder

Cannabinoids and EpilepsyA study recently published in Neurotherapeutics by researchers at the New York University School of Medicine reviews scientific evidence from pre-clinical and clinical trials of cannabinoids in epilepsy. These studies suggest that CBD avoids the psychoactive effects of the endocannabinoid system to provide a well-tolerated, promising therapeutic for the treatment of seizures. Future placebo-controlled clinical trials will provide insight into cannabinoid function and the potential neuroprotective effects of the endocannabinoid system. Read More

Marijuana Use in Epilepsy: The Myth and the Reality

By | Epilepsy, Research Articles

Marijuana Use in Epilepsy: The Myth and the RealityResearchers at Yale University published this review in Current Neurology and Neuroscience Reports in 2015 with the goal of addressing the most important questions a clinician may have regarding the use of marijuana in epilepsy. They review data for the anticonvulsant properties of the different cannabinoids, mainly tetrahydrocannabinol (THC) and cannabidiol (CBD) and explore the safety data from animal and human studies. Read More

THC Inhibits Replication of Herpesviruses in Vitro

By | Research Articles, THC herpes

THC Inhibits Replication Of Herpes Viruses In VitroResearchers at the University of South Florida published an article in BioMed Central in 2004 summarizing the antiviral effects of THC and comparing THC with well-characterized antiviral drugs. They compiled data from the literature as well as from their own experimental results. The authors’ observations suggest that THC either directly or indirectly targets a viral gene shared by the herpesviruses. Read More

Cannabinoid Hyperemesis Syndrome: An Under-Recognized Diagnosis

By | Cannabinoid Hyperemesis Syndrome (CHS), Research Articles

Cannabinoid Hyperemesis Syndrome: An Under-Recognized DiagnosisWith the growing spread of cannabis abuse, a novel clinical disorder has emerged, termed Cannabinoid Hyperemesis Syndrome (CHS).

Researchers in Israel published a Case Communications report in the Israel Medical Association Journal in May 2015. The majority of patients with CHS are heavy users of cannabinoids, on a daily or almost daily basis for years.

Symptoms are characterized by recurrent attacks of severe nausea and vomiting and accompanying abdominal pain. Read More