PharmaDrug becomes first company to receive Orphan Drug Designation for DMT from the US FDA

PharmaDrug Inc (CSE:BUZZ) (OTCPINK:LMLLF) announced that it has received Orphan Drug Designation for its dimethyltryptamine (DMT) formulation to prevent ischemia-reperfusion injury from organ transplantation from the US Food and Drug Administration (FDA).  The designation was granted to PharmaDrug’s subsidiary Sairiyo Therapeutics Inc and covers solid organ transplantation, which includes the liver, kidney, heart and lungs.  According to Toronto-based PharmaDrug, the orphan drug designation is broader than its original application, which was for kidney transplantation only.  READ: PharmaDrug signs deal to begin manufacturing potential esophageal cancer and coronavirus treatment Cepharanthine PharmaDrug told shareholders that the FDA’s decision to broaden the designation recognizes the “pernicious consequences” of ischemia-reperfusion injury (IRI) in all solid organ transplantation. Daniel Cohen, PharmaDrug’s CEO, told investors that the company is the only company in the world that has received orphan drug designation for DMT. "We are incredibly pleased to have reached this significant milestone as it validates our strategy in discovering novel uses, formulations and delivery methods for DMT while also securing market exclusivity and patent protection of DMT for rare diseases,” Cohen said in a statement. Cohen added that the company is building on the achievement by positioning its research initiatives to evaluate DMT in potential human clinical studies for these types of serious and life-threatening indications. The company is currently evaluating specific DMT formulations aimed at superior delivery and improved efficacy. Its management will contemplate additional pre-clinical research in inflammatory and oxidative stress-induced complications, including organ transplants, to better understand the role DMT plays in the field. PharmaDrug is focused on the research, development and commercialization of controlled-substances and natural medicines such as psychedelics, cannabis and naturally-derived approved drugs. Contact Angela at angela@proactiveinvestors.com Follow her on Twitter @AHarmantas