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.
