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Research

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

Research Pioneer: Ethan Russo MD

By | Cardiovascular, Pain, Research, Research Articles

ethan-russo2Ethan Russo, MD, is a board-certified neurologist and psychopharmacology researcher. He has held faculty appointments in Pharmaceutical Sciences at the University of Montana, in Medicine at the University of Washington, and as visiting professor, Chinese Academy of Sciences. He is currently Past-President of the International Cannabinoid Research Society, and is former Chairman of the International Association for Cannabinoid Medicines.

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