The same previous designation by the US Drug Enforcement Administration alleviates the typical complexities associated with developing controlled substances throughout North America
SAN DIEGO, CA, March 23, 2020 (GLOBE NEWSWIRE) -- Emerald Health Pharmaceuticals Inc. (EHP), a clinical-stage company developing medicines based on cannabinoid science, has received the determination from Canada’s Controlled Substances Directorate that its lead product candidate, EHP-101, is not a controlled substance under its Controlled Drug and Substance Act (CDSA). The patented active ingredient in EHP-101 is a non-psychoactive novel molecule chemically derived from synthetic cannabidiol (CBD). EHP-101 is currently entering Phase 2 clinical development for the treatment of systemic sclerosis (SSc) and multiple sclerosis (MS).
"The determination in Canada that EHP-101 is not a controlled substance adds to the same determination by the US DEA last year, providing us more flexibility in advancing our clinical program globally,” said Jim DeMesa, M.D., President & Chief Executive Officer of EHP. “These determinations by Canada and the US also highlight the important difference between our novel molecules compared to natural cannabinoids. We plan to continue seeking these determinations in various countries as we expand our clinical program throughout the world.”
A multi-national Phase 2a clinical study on EHP-101 in SSc patients is currently being initiated. In general, the determination of not being a controlled substance eliminates the costs and complexities otherwise associated with developing controlled substances. Among other things, manufacturing facilities do not require controlled substance certification for handling and dispensing the molecules and drug products, it facilitates importation, and it simplifies the conduct of nonclinical and clinical studies, as contracted nonclinical research organizations and clinical sites have less administrative burden.
About the Canadian Controlled Drug and Substance Act
The Canadian Controlled Drug and Substances Act (CDSA) and its regulations provide a framework for the control of substances that can alter mental processes and that may produce harm to an individual or to society when diverted to an illicit market. Scheduling substances under the CDSA provides Canadian law enforcement agencies with the authority to take action against illicit activities with those substances. Examples of substances regulated under the CDSA include oxycodone, cocaine, opium, codeine, morphine and cannabis.
About Emerald Health Pharmaceuticals Inc.
Emerald Health Pharmaceuticals is developing novel product candidates derived from cannabinoids for the treatment of CNS, autoimmune, fibrotic 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 product candidate, EHP-101, has completed a Phase 1 clinical study and Phase 2 clinical development has been initiated, focusing initially on treating systemic sclerosis (a severe form of scleroderma) and multiple sclerosis. Its second product candidate, EHP-102, is in preclinical development and is focused initially on treating Huntington’s disease and Parkinson’s disease. EHP has received Orphan Drug designation in the US and EU for EHP-101 in systemic sclerosis and EHP-102 in Huntington’s disease. For more information, visit http://www.emeraldpharma.life or contact EHP at email@example.com.
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.