Biotechnology company focused on development and commercialization of natural medicine and controlled substances including cannabis and psychedelics PharmaDrug Inc. (CSE: BUZZ) (OTC: LMLLF) announced having been granted U.S. Food and Drug Administration (FDA) Orphan Drug Designation (ODD) of dimethyltryptamine (DMT) for prevention of Ischemia-reperfusion injury in patients undergoing organ transplants.
This goes down as the first ever Food and Drug Administration orphan drug designation for the company.
The approval captures patients undergoing solid organ transplants including heart, liver and the heart. The approval also recognizes the pernicious consequences of ischemia-reperfusion injury (IRI) in all solid organ transplantation.
The company’s chief executive Daniel Cohen confirmed the approval further saying they are the first ever company to receive a FDA orphan drug designation for DMT. Cohen also said this will push them to evaluate DMT in potential human clinical trials for these type of serious organ transplants.
“We are the first and only company in the world to receive FDA 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. We are building on this achievement by positioning our research initiatives to evaluate DMT in potential human clinical studies for these types of serious and life-threatening indications,” said the CEO.