FDA Grants Orphan Drug Designation for Cannabidiol in the Prevention of Ischemia and Reperfusion Injury from Organ Transplantation

  • The FDA also previously granted orphan drug designation for cannabidiol in the treatment of autoimmune hepatitis
  • Revive is developing cannabinoid pharmaceuticals to treat rare inflammatory conditions and liver disease

Revive Therapeutics Ltd. (TSX VENTURE: RVV) (OTCQB: RVVTF) (FSE:31R) ("Revive" or the “Company”), a specialty cannabis company focused on the research, development and commercialization of novel cannabinoid-based products, today announced that the U.S. Food and Drug Administration (“FDA”) has granted orphan drug designation for cannabidiol (“CBD”) in the prevention of ischemia and reperfusion injury (“IRI”) resulting from solid organ transplantation.

"We are very pleased to receive orphan drug designation for CBD in the prevention of IRI resulting from solid organ transplantation, such as liver, kidney, heart and lung, as it complements on our first FDA granted orphan drug designation for cannabidiol in the treatment of autoimmune hepatitis, a rare liver disease, and provides us with a unique cannabinoid pharmaceutical product pipeline that is in line with our overall ambition in becoming a leading global specialty medical cannabis company,” said Fabio Chianelli, President of Revive.  "This milestone builds on Revive’s pharmaceutical strategy in developing novel cannabinoid therapies targeting both broad and rare inflammatory diseases and it supports our near-term product and business development strategy in commercializing novel cannabis-based therapies and potential partnering opportunities with licensed producers of cannabis and pharmaceutical companies.”

According to the U.S. Organ Procurement and Transplantation Network, there are approximately 115,000 patients waiting for solid organ transplants in the United States, with the four most common organs transplanted being liver, kidney, heart and lung. IRI in organ transplantation can result in a higher incidence of acute and chronic rejection, as well as long-term morbidity and mortality. Quickly restoring blood supply of ischemic organs as soon as possible is crucial for avoiding or reducing injury from ischemia, whereas strategies used to attenuate the damage induced by reperfusion, including ischemic preconditioning, ischemic postconditioning, and machine perfusion.  These strategies are expensive, sometimes hard to perform in clinical surgeries, and difficult in maintaining organ functions in the case of acute injuries. With the shortage of organs and expensive medical strategies, it is clear that therapies need to be researched to optimize the quality of the organs that are available and to attenuate injury to transplanted organs. Revive believes that the immunosuppressant and anti-inflammatory protective effects of CBD may provide a novel, more beneficial strategy to attenuate the damage induced by ischemia and reperfusion during solid organ transplantation.

Revive currently markets a CBD based chewing gum. The company is developing a portfolio of cannabinoid pharmaceuticals focused on treating rare inflammatory and liver diseases.