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.
We are sorry that this post was not useful for you!
Let us improve this post!
Tell us how we can improve this post?