Emerald Health Pharmaceuticals Receives U.S. Drug Enforcement Administration Determination that the Active Ingredient in its Lead Product Candidate is not a Controlled Substance
Development of EHP-101, a clinical-stage cannabidiol (CBD) derivative, simplified by DEA determination
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.
About the Controlled Substance Act
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 http://www.emeraldpharma.life or contact: firstname.lastname@example.org.
To the extent statements contained in this news release are not descriptions of historical facts regarding Emerald Health Pharmaceuticals Inc. they should be considered "forward-looking statements," as described in the private securities litigation reform act of 1995, that reflect management's current beliefs and expectations. You can identify forward-looking statements by words such as "anticipate," "believe," "could," "estimate," "expect," "forecast," "goal," "hope," "hypothesis," "intend," "may," "plan," "potential," "predict," "project," "should," "strategy," "will," "would," or the negative of those terms, and similar expressions that convey uncertainty of future events or outcomes. Forward-looking statements contained in this news release include, but are not limited to, statements regarding: (i) the success and timing of our product development activities and clinical trials; (ii) our ability to develop our product candidates; (iii) our plans to research, discover, evaluate and develop additional potential product, technology and business candidates and opportunities; (iv) the anticipated timing of clinical data availability; (v) our ability to meet our milestones; and (vi) our expectations regarding our ability to obtain and maintain intellectual property protection. Forward-looking statements are subject to known and unknown factors, risks and uncertainties that may cause actual results to differ materially from those expressed or implied by such forward-looking statements. Undue reliance should not be placed on forward-looking statements. We undertake no obligation to update any forward-looking statements. Emerald Health Pharmaceuticals' investigational drug products have not been approved or cleared by the FDA.