World News: 13:00 GMT Wednesday 17th April 2019. [Emerald Health Pharmaceuticals via Globe Newswire via SPi World News]
SAN DIEGO, CA, April 17, 2019 (GLOBE NEWSWIRE) -- Emerald Health Pharmaceuticals Inc. (EHP), a clinical-stage company developing medicines based on cannabinoid science, has received the determination from the United States Drug Enforcement Administration (DEA) that VCE-004.8, a non-reactive, non-psychotropic, new chemical entity (NCE) derived from synthetic cannabidiol (CBD) and the active pharmaceutical ingredient (API) in the Company’s lead product candidate, EHP-101, is not a controlled substance under the Controlled Substance Act (CSA). EHP-101 is currently in a Phase I clinical study and is being developed for the treatment of multiple sclerosis (MS) and systemic scleroderma, or systemic sclerosis (SSc).
"This determination by the DEA that our lead product candidate, EHP-101, is not considered a controlled substance in the U.S. is of great benefit to us,” said Jim DeMesa, M.D., Chief Executive Officer of EHP. “Not being a controlled substance eliminates the many costs and complexities associated with developing controlled substances. 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 II studies for MS and SSc patients.”
EHP-101 is currently in a Phase I clinical study being conducted in healthy volunteers in Australia as a randomized, double-blind, placebo-controlled study. The Company expects to report top-line results on this Phase I study later this year and initiate Phase II clinical studies in MS and SSc patients thereafter.
The Controlled Substances Act is the U.S. federal statute that regulates the manufacture and distribution of controlled substances, such as hallucinogens, narcotics, depressants, and stimulants. The Act categorizes drugs into five classifications or “schedules” based on their potential for abuse, status in international treaties, and any medical benefits they may provide. Generally speaking, drugs included in Schedule 1, for example, ecstasy, LSD, and heroin, are the most strictly regulated, because they are deemed to have no medical value. Marijuana (cannabis) is also considered a Schedule 1 drug, despite studies finding it to have medical uses.
Emerald Health Pharmaceuticals is developing product candidates derived from cannabinoids for the treatment of CNS, autoimmune, and other diseases. The Company has two families of new chemical entities, derived from synthetic cannabidiol (CBD) and cannabigerol (CBG), that it has modified through rational drug design to affect validated receptors and pathways pertinent to targeted diseases. Its first drug candidate, EHP-101, is in Phase I clinical development and is focused on treating multiple sclerosis and systemic scleroderma. Its second drug candidate, EHP-102, is in preclinical development and is focused on treating Huntington’s disease and Parkinson’s disease. For more information, visit or contact: .
Globe Newswire: 13:00 GMT Wednesday 17th April 2019
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