FDA Approves New Indication For Drug Containing An Active Ingredient Derived From Cannabis To Treat Seizures In Rare Genetic Disease

DISTRICT OF COLUMBIA: Last month, the U.S. Food and Drug Administration approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with tuberous sclerosis complex (TSC) in patients one year of age and older. Epidiolex was previously approved for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome (LGS) and Dravet syndrome (DS). This is the only FDA-approved drug that contains a purified drug substance derived from cannabis. It is also the second FDA approval of a drug for the treatment of seizures associated with TSC.

CBD is a chemical component of the Cannabis sativa plant. However, CBD does not cause intoxication or euphoria (the “high”) that comes from tetrahydrocannabinol (THC). It is THC (and not CBD) that is the primary psychoactive component of cannabis.

“The FDA continues to believe the drug approval process represents the best way to make new medicines, including any drugs derived from cannabis, available to patients in need of appropriate medical therapy such as the treatment of seizures associated with these rare conditions. This paradigm ensures new therapies are safe, effective, and manufactured to a high quality that provides uniform and reliable dosing for patients,” said Douglas Throckmorton, M.D., deputy center director for regulatory programs in the FDA’s Center for Drug Evaluation and Research. “The agency is committed to supporting rigorous scientific research on the potential medical uses of cannabis-derived products and working with product developers who are interested in bringing patients safe and effective, high quality products.”

TSC is a rare genetic disease that causes non-cancerous (benign) tumors to grow in the brain and other parts of the body like the eyes, heart, kidneys, lungs, and skin. TSC usually affects the central nervous system and can result in a combination of symptoms including seizures, developmental delay, and behavioral problems, although the signs and symptoms of the condition, as well as the severity of symptoms, vary widely. TSC affects about 1 in 6,000 people.

Epidiolex’s effectiveness for the treatment of seizures associated with TSC was established in a randomized, double-blind, placebo-controlled trial where 148 patients out of a total of 224 in the study received Epidiolex. The study measured the change from baseline in seizure frequency. In the study, patients treated with Epidiolex had a significantly greater reduction in the frequency of seizures during the treatment period than patients who received placebo (inactive treatment). This effect was seen within eight weeks and remained consistent throughout the 16-week treatment period.

The most common side effects that occurred in Epidiolex-treated patients with TSC in the clinical trial were: diarrhea, elevated liver enzymes, decreased appetite, sleepiness, fever, and vomiting. Additional side effects for patients with LGS, DS, or TSC include: liver injury, decreased weight, anemia, and increased creatinine.

Epidiolex must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and risks. As is true for all drugs that currently treat epilepsy, including Epidiolex, the most serious risks may include an increase in suicidal thoughts and behavior, or thoughts of self-harm. Patients, their caregivers, and their families should be advised to monitor for any unusual changes in mood or behavior, such as worsening depression, suicidal thoughts or behavior. Patients, caregivers, and families should report behaviors of concern immediately to healthcare providers. Epidiolex also caused liver injury in some patients. Most cases were generally mild, but a risk of rare, but more severe liver injury exists. More severe liver injury can cause nausea, vomiting, abdominal pain, fatigue, anorexia, jaundice, and/or dark urine.

The FDA granted Priority Review designation for this application. The approval of Epidiolex was granted to Greenwich Biosciences Inc., of Carlsbad, California.

The Blinc Group And Think20 Labs Announce Research Partnership Focused On Cannabis Vaping Emissions

NEW YORK: The Blinc Group, the leading provider of customized vaping solutions for the Cannabis industry, and Think20 Labs, an analytical testing laboratory for Hemp and Cannabis, announced a research partnership. The objective of this research is to develop a vaping apparatus that helps identify possible dangerous compounds that are inhaled by consumers. More in-depth research will be conducted looking at how the chemicals in the matrices break down as they are vaporized while also analyzing which products can be recommended for safe consumption.

The research partnership combines The Blinc Group’s deep experience in vaping technologies with Think20 Labs’s expertise in pharmaceutical-grade analysis. The Blinc Group’s participation will be headed by the product standards work of Arnaud Dumas de Rauly, CEO of The Blinc Group, Chairman of the ISO Standards on Vaping Products and Chairman of CEN Standards on Vaping Products, and Think20 Labs’s participation will be managed by Conor Jenkins, the scientific director and lead bioinformatician of Think 20 Labs.

Research, development, and implementation of standardized test methods will include, among others, emissions of cannabinoids, terpenes, VOCs, carbonyl compounds, nitrosamines, and heavy metals.

“We are delighted to be joining forces with the forward-thinking science team at Think20 Labs, to research the creation of innovative, safe and tested cannabis vaping products. The Blinc Group and Think20 Labs share a commitment to responsible product development, based on science and experience, in order to address the current vaping issues. We look forward to beginning our work on this important partnership as The Blinc Group continues to strive for a professional, transparent, and sensibly-regulated cannabis industry,” said Arnaud Dumas de Rauly, CEO of The Blinc Group.

Conor Jenkins states: “The overall goal is to drive the regulations regarding these products and informing regulatory bodies of our findings in hopes that we can show an area that has been dangerously overlooked in this field.”

First US Clinical Study Assessing Hemp-Derived Cannabinoid Supplementation In Recovery From Traumatic Brain Injury Begins In Colorado

COLORADO:  The Flowering HOPE Foundation and Clover Leaf University have just announced sponsorship and collaboration on the first US clinical study to be approved to investigate plant-derived cannabinoid supplements in recovery from brain injury. 

The study will analyze quantitative EEG brain activity and a cannabinoid-sensitive salivary biomarker in 40 subjects with mild traumatic brain injury and controls who currently take hemp-derived botanical supplements on a regular basis (i.e. phytocannabinoids). The study is recruiting adults age 18 to 55 to participate in the year-long trial. 

Jason Cranford, Founder of the Flowering HOPE Foundation, a Colorado registered 501(c)(3) nonprofit organization that supports the medicinal use of plant-derived cannabinoids, called phytocannabinoids, described the motivation for sponsoring the study: “We hope to provide scientific support for the benefits of the natural plant-based compounds contained in hemp and move a step closer towards the unrestricted availability of non synthetic cannabinoid therapeutics.”

Cranford is a pioneer in the emerging cannabis industry with more than 25 years experience in cultivation, extraction and formulations. His know-how allowed him to breed a unique hemp strain selected for a blend of phytoterpenes and phytocannabinoids designed to alleviate treatment-resistant epilepsy in children without psychoactive side effects. The resulting strain, called Haleigh’s Hope, was formulated into a supplement offered by the FHF (2013). 

The FHF has partnered with Clover Leaf University to study brain injury. The President and Founder, Chloe Villano, received accredited approval for CLU in 2013 by the Colorado Department of Higher Education’s Private Occupational School Board. Villano is a pioneer in the cannabis and hemp industry and prioritized brain injury for the study.

“This historic study is the first of its kind and it is a privilege to work with the Flowering HOPE Foundation to address the problem of brain injury and collaborate with a neuroscientist who understands the brain endocannabinoid system, such as Dr. Cooper. There are currently no effective treatments for traumatic brain injury or chronic traumatic encephalopathy, but phytocannabinoids may be a good candidate, based on the established science of anti-inflammatory and neuroprotective mechanisms. Clover Leaf University is excited to take the lead in clinical studies that will improve and save lives,” said Villano.

The lead neuroscientist responsible for the study,  Don Cooper, Ph.D, is President of Real-Time Diagnostics Ventures Inc. He has published 45 peer reviewed papers on neuronal memory formation/plasticity and has studied brain cannabinoids since 2000, when he received his first NIH grant. 

“I never thought it would take almost 20 years from when I started working on the brain cannabinoid system to have the first approved clinical study on phytocannabinoids and brain injury. We have convincing preclinical data showing that phytocannabinoids are neuroprotective and may be critically important for restoring neuronal function after brain injury,” stated Cooper.

For more information contact the study Clinical Coordinator at TBIstudy@protonmail.com.

Study: Majority Of Medical Cannabis Patients Are Seeking Pain Relief

MICHIGAN: Most US patients registered to access medical cannabis cite chronic pain as their primary qualifying condition, according to data published in the journal Health Affairs.

Investigators from the University of Michigan, Ann Arbor reviewed patient registration data from the majority of states that provide medical cannabis access. (Some states, notably California and Maine, possess voluntary registries and therefore do not compile patient profile data.)

They reported that in 2016, chronic pain was the most common qualifying condition reported by patients (65 percent). They added, “Of all patient-reported qualifying conditions, 85 percent had either substantial or conclusive evidence of therapeutic efficacy,” as defined by the 2017 report published by the National Academy of Sciences, Engineering, and Medicine. The authors of that report concluded that there exists conclusive or substantial evidence for the effectiveness of cannabis in the treatment of chronic pain, nausea and vomiting, and spasticity.

Separate studies indicate that legal cannabis access is typically associated with reduced rates of opioid use and abuse. Studies have also identified a reduction in the prevalence of opioid-related mortality following statewide marijuana access.

Authors concluded: “[O]ur data show that the number of medical cannabis patients has risen dramatically over time as more states have legalized medical cannabis. … [W]e believe not only that it is inappropriate for cannabis to remain a Schedule I substance, but also that state and federal policy makers should begin evaluating evidence-based ways for safely integrating cannabis research and products into the health care system.”


For more information, contact Paul Armentano, NORML Deputy Director, at: paul@norml.org. Full text of the study, “Qualifying conditions of medical cannabis license holders in the United States,” appears in Health Affairs. Additional information is available in NORML’s fact-sheet, “Relationship Between Marijuana and Opioids.”

Medical Schools Including Cannabis Content In Their Curriculum

PENNSYLVANIA: A growing percentage of colleges of pharmacy are instituting medical cannabis training as part of their curriculum, according to survey data published in the journal Currents in Pharmacy Teaching and Learning.

Researchers at the University of Pittsburgh contacted 140 US schools of pharmacy regarding whether they include medical cannabis-related topics in their curriculum. Among respondents, 62 percent reported that they had instituted some level of medical marijuana training, while 23 percent answered that they intended to incorporate the topic to their coursework within the next 12 months.

The study is the first inventory of medical schools with regard to the inclusion of medical cannabis-related topics to their curriculum.

According to a 2015 evaluation of student pharmacists’ attitudes, 90 percent of respondents indicated that they favored the inclusion of medical cannabis instruction to their curriculum.


For more information, contact Paul Armentano, NORML Deputy Director, at: paul@norml.org. Full text of the study, “Evaluation of medical marijuana topics in the PharmD curriculum: A national survey of schools and colleges of pharmacy,” appears in Currents in Pharmacy Teaching and Learning.

Case Report: Daily CBD Administration Associated With Remission Of Schizophrenic Symptoms

GERMANY: The adjunctive use of cannabidiol is associated with a remission in schizophrenic symptoms in a patient previously unresponsive to conventional treatment, according to a case report published in the Australian & New Zealand Journal of Psychiatry.

Investigators from the University of Leipzig in Germany assessed the use of twice-daily dosing of 750mg of CBD in conjunction with clozapine in a patient with treatment-resistant schizophrenia. Cannabidiol dosing was associated with remission criteria and improvements remained consistent over eight months.

“Our case report contradicts the assumption that CBD is not likely to be any superior than existing antipsychotics,” authors concluded. “In fact, CBD might be particularly suitable for those patients [who are] resistant to antipsychotics due to its different mode of action.”


For more information, contact Paul Armentano, NORML Deputy Director, at: paul@norml.org. Full text of the study, “Remission of severe, treatment-resistant schizophrenia following adjunctive cannabidiol,” appears in the Australian & New Zealand Journal of Psychiatry.

Thousands Of Peer-Reviewed Studies Specific To Medical Cannabis Have Been Published Over Past Decade

ISRAEL: The total number of peer-reviewed scientific papers dedicated to cannabis, and the therapeutic use of cannabis in particular, has increased exponentially in recent years, according to data published the journal Population Health Management.

Israeli researchers assessed trends in the number of scientific publications specific to cannabis as compared to all scientific publications during the years 2000 to 2017. They reported: “The overall annual number of scientific publications … increased 2.5 times between 2000–2017 from 531,664 to 1,282,229. In contrast, the corresponding number for publications on cannabis increased 4.5 times … and increased 9-fold for publications on medical cannabis.”

Overall, authors identified just over 29,000 cannabis-centric scientific papers published during the study period, with over 3,300 of those dedicated to the subject of medical marijuana. Papers specific to medical cannabis were most likely to address its use in the treatment of HIV, chronic pain, multiple sclerosis, nausea, or epilepsy.

Over 60 percent of the papers were classified as “original research,” and 66 percent of all scientific papers originated from authors in the United States.


For more information, contact Paul Armentano, NORML Deputy Director, at: paul@norml.org. Full text of the study, “Trends in publications in medical cannabis from the year 2000,” appears in Population Health Management.

Patients Frequently Turning To Cannabis To Treat Symptoms Of Sickle Cell Disease

CONNECTICUT: Medical cannabis use is relatively common among patients with sickle cell disease, according to survey data published in the journal Cannabis and Cannabinoid Research.

Investigators at Yale University conducted an anonymous questionnaire among 58 patients with the disease. Forty-two percent of respondents reported having used cannabis within the past two years, and 31 percent reported having used it within the past month. Most respondents said that said they did so for therapeutic purposes. Common symptoms of sickle cell disease include pain, fatigue, and swelling of the hands and feet.

Many respondents acknowledged that the use of cannabis “allowed for less use of pain medications” – a finding that is consistent with reports from other cohorts of chronic pain patients.

To date, the use of medicinal cannabis has not been evaluated in controlled settings for patients with sickle cell disease.

Authors concluded: “From our study as well as a few other reports, it appears that many adults with sickle cell disease use marijuana in the belief that it has medicinal benefits. … Thus, there is a strong rationale for the study of the medicinal properties of marijuana and/or its constituents in sickle cell disease.”


For more information, contact Paul Armentano, NORML Deputy Director, at: paul@norml.org. Full text of the study, “Marijuana use in adults living with sickle cell disease,” appears in Cannabis and Cannabinoid Research.

Patients Dramatically Reduce Their Opioid Use Following Cannabis Access

CANADA: Pain patients enrolled in Canada’s legal medical cannabis access program significantly reduce their use of opioids over the long-term, according to longitudinal data provided by Tilray Canada Ltd – one of the nation’s largest, licensed provider of medicinal marijuana products.

Investigators assessed opioid use patterns in a cohort of 573 patients using Tilray-provided products. Among those patients who acknowledged using opioids upon enrollment in the trial, 51 percent reported ceasing their opiate use within six-months.

“The high rate of cannabis use for the treatment of chronic pain – and subsequent substitution for opioids – suggests that cannabis may play a harm-reduction role in the ongoing opioid dependence and overdose crisis,” said Philippe Lucas, lead investigator of the Tilray Observational Patient Study. “While the cannabis substitution effect for prescription drugs has been identified and assessed via cross-sectional and population-level research, this study provides a granular individual-level perspective of cannabis substitution for prescription drugs and associated improvement in quality of life over time.”

The study’s findings are similar to those reported among enrollees in medical cannabis programs in the United States, such as the experiences of patients in IllinoisMichiganMinnesotaNew Mexico, New York, and elsewhere.


For more information, contact Paul Armentano, NORML Deputy Director, at: paul@norml.org. NORML’s fact-sheet highlighting the relevant, peer-reviewed research specific to the relationship between cannabis and opioids is available online.

Patients Use Fewer Opioids Following Enrollment In Medical Cannabis Program

NEW YORK:  Patients enrolled in New York state’s medical cannabis program reduce their use of opioids and spend less money on prescription medications, according to data published online in the journal Mental Health Clinician.

Investigators from GPI Clinical Research labs in Rochester and the University of Buffalo assessed trends in patients’ medical cannabis and prescription drug use following their enrollment in the state’s marijuana access program.

On average, subjects’ monthly analgesic prescription costs declined by 32 percent following enrollment, primarily due to a reduction in the use of opioid pills and fentanyl patches. “After three months treatment, medical cannabis improved [subjects’] quality of life, reduced pain and opioid use, and lead to cost savings,” authors concluded.

The study’s findings are similar to those reported among enrollees in other states’ medical cannabis programs, including the experiences of patients in IllinoisMichiganMinnesotaNew Mexico, and elsewhere.


For more information, contact Paul Armentano, NORML Deputy Director, at: paul@norml.org. Full text of the study, “Preliminary evaluation of the efficacy, safety, and costs associated with the treatment of chronic pain with medical cannabis,” appears in The Mental Health Clinician. NORML’s fact-sheet highlighting the relevant, peer-reviewed research specific to the relationship between cannabis and opioids is available online.