Pharmadrug Files for FDA Orphan Drug Destination for DMT Treatments
Pharmadrug is a specialty pharmaceutical company involved in the research, development, and commercialization of controlled substances and all-natural medicines including psychedelics like DMT, cannabis, and naturally occurring drug derivatives.
The Orphan Drug Act designates special status to a drug or biological product to treat a rare disease or condition by the request of a sponsor. FDA grants ODD status to products that treat rare diseases providing incentives to sponsors developing rare drugs or Biologics. PharmaDrug will be researching DMT for treating ischemic stroke, this is characterized by the sudden loss of blood circulation to the areas of the brain resulting in loss of neurological function. In preclinical research, Studies show DMT improved ischemic brain injury in rats. Results showed decreased brain lesions and improve subsequent motor function recovery. DMT activates sigma-1 receptors and critical downstream pathways known to enhance the production of antistress antioxidant proteins. Administration of tissue plasminogen activators diminishes the impact of hypoxia and oxidative stress on brain cells restoring blood flow to affected regions of the brain. These traditional treatments for ischemic stroke victims only prevented partial areas of the brain from being damaged. DMT seems to show amazing results on blood flow and brain activity. Pharmadrug's psychedelic pharmaceutical strategy will focus on DMT by expanding product line with licensing their clinical research and working with academic institutions to develop novel uses and delivery systems of unique psychedelic formulations.