The U.S. Drug Enforcement Administration (DEA) has determined that the cannabidiol-based active ingredient of EHP-101, an investigational oral treatment for multiple sclerosis (MS) under development by Emerald Health Pharmaceuticals (EHP), should not be classified as a controlled substance.
According to Jim DeMesa, MD, Emerald’s chief executive officer, the DEA’s decision is of “great benefit” and facilitates development of the product.
“Not being a controlled substance eliminates the many costs and complexities associated with developing controlled substances,” DeMesa said in a press release.
“It facilitates the manufacturing and import of the product to the U.S. and simplifies the conduct of our non-clinical and clinical studies, including the selection of U.S. clinical sites to conduct our planned Phase 2 studies for MS and SSc [systemic sclerosis] patients,” DeMesa added.
Under federal law (Controlled Substance Act), the DEA and the U.S. Food and Drug Administration (FDA) can determine which substances are added or removed from the list of controlled substances, which, in some situations, also may be enacted by the U.S. Congress.
Under this act, substances are placed into five categories, or schedules, according to their potential for abuse, status in international treaties, and medical benefits they may provide.
The compound under review, VCE-004.8, is the active ingredient in EHP-101, the company’s lead candidate for the treatment of MS and systemic sclerosis.
The ingredient is a lab-made chemical derived from cannabidiol (CBD), a natural substance found in cannabis (marijuana) and hemp plants. CBD is considered non-reactive and non-psychotropic.
Earlier studies in MS mouse models demonstrated that EHP-101 had promising neuroprotective effects that could prevent nerve cell damage and enhance remyelination.
These results encouraged EHP to undertake a Phase 1 clinical study (NCT03745001) that is currently evaluating the safety, tolerability and pharmacokinetics (absorption, distribution, metabolism, and elimination in the body) of a liquid form of EHP-101 in healthy volunteers.
In the first part, participants will be assigned to receive a single ascending daily dose of the compound, or a placebo. In the second part, participants will be given EHP-101 or placebo in multiple ascending daily doses for seven days, based on the results obtained in the first part of the study. Enrollment is taking place in Australia.
EHP-101 has been granted the orphan drug status by the FDA and European Medicines Agency (EMA) as a potential treatment for systemic sclerosis.
In the U.S., cannabidiol currently is a schedule 1 drug, prohibited for any use, ranking along with drugs such as heroin, LSD, and cocaine. The only exception is if the formulation is FDA-approved, containing no more than 0.1% tetrahydrocannabinol, in which case it is classified as schedule 5.
I smoke marijuana daily and have tysabri once a month. I believe that is why I’ve made it. I have had multiple sclerosis for 20 years and have 3 children. And been successful.
Karrie,
Do you use the stuff “off the street” or the medicinal type? Nothing wrong with using either I know. I was approved for the medicinal & will get. Although I have some of the other at home I wanted to try the medicinal stuff also to compare. Thanks…..Mike
Same here. 2 kids and 14 years.
So, give up a natural product for a synthetic lab made??
Finally someone notices. The real thing please.
You are probably misunderstanding the connotation of ‘synthetic’, David. All synthetic means is that they have isolated the amino quinone, which is found in all sativa strains. Then they extract it and remove impurities like tannic acid and phenols to concentrate the amino quinone. Then they give it a new name EHP101. There is nothing truly synthetic but the chemicals used to remove the impurities. Like homogenizing milk to create a vitamin D rich formula. Like removing chaff from wheat to create flour. In fact, making ehp101 or who 102 would be relatively easy to do with household materials and some very basic lab equipment.
Sounds similar to Sativex, a cannabis based mouth spray used safely and effectively in Europe for years. Let’s get with the program. Most DMTs are poison in my opinion. Read the lab sheets and tell me what you think. Time to start healing the patient and stop hurting the patient!
I actually had this concern regarding the use of natural organic substances to create inorganic, synthetic and “enhanced” I can see the profitability factor but what potential unintended consequences might their be on patient? It’s great to have a measurable, consistent model that enhances dosing and outcome study but….
Did any of you actually read the study? Synthetic does not mean inorganic in this context! It means synthesis as extracting or purifying a substance already there. When you depulp orange juice and remove the hydrogen you are left with a synthetic concentrate. It’s the same concept.