Much More Clear Nr . Sh - PharmaDrug Inc. (BUZZ) has filed an application with the FDA to receive Orphan Drug Designation for N-Dimethyltryptamine (DMT)
- In pre-clinical research, DMT has been shown to improve ischemic brain injury in rats
- PharmaDrug's psychedelic pharmaceutical strategy will focus on DMT by expanding its product pipeline through licensing
- The FDA grants ODD status to products that treat rare diseases
- PharmaDrug (BUZZ)is up 14.29 per cent and is trading at C$0.12 at 1:03 pm EST
PharmaDrug Inc. (BUZZ) has filed an application with the FDA to receive Orphan Drug Designation for N, N-Dimethyltryptamine (DMT).
This application is said to help treat acute ischemic stroke patients presenting for emergency medical assistance within three-hours of symptom onset.
Acute ischemic stroke is characterized by the sudden loss of blood circulation to an area of the brain, resulting in a corresponding loss of neurologic function.
Around 85 per cent of all strokes are due to a blockage cutting off the blood supply to the brain.
Stroke-related costs in the United States were approximately $46 billion between 2014 and 2015.
In pre-clinical research, DMT has been shown to improve ischemic brain injury in rats, both by decreasing brain lesion volume and by improving subsequent motor function recovery.
Restoration of blood flow to affected regions of the brain through the administration of tissue plasminogen activator (tPA aka alteplase), long considered the gold-standard treatment for ischemic stroke, often only partially rescues damaged brain regions.
The development of novel approaches to treat ischemic stroke, such as PharmaDrug's DMT program, represent a critical development in reducing patients' resulting neurological deficit.
"We are building an industry-leading foundation to explore the clinical potential of DMT in rare neuropsychiatric and neurological disorders. With the submission of our orphan drug application to the FDA now complete we will move swiftly to accelerate the research and development of DMT for acute ischemic stroke," said Daniel Cohen, CEO of PharmaDrug.
"Additionally, we will continue to broaden our DMT clinical programs by taking advantage of valuable FDA regulatory incentives such as orphan drug, fast track and breakthrough therapy designations," added Cohen.
PharmaDrug's psychedelic pharmaceutical strategy will focus on DMT by expanding its product pipeline through licensing, pre-clinical and clinical research, forming research collaborations with academic institutions and industry.
The Orphan Drug Act grants special status to a drug or biological product to treat a rare disease or condition upon request of a sponsor.
This status is referred to as orphan designation.
The FDA grants ODD status to products that treat rare diseases, providing incentives to sponsors developing drugs or biologics.
PharmaDrug is a specialty pharmaceutical company focused on the research, development and commercialization of controlled-substances and natural medicines such as psychedelics, cannabis and naturally-derived approved drugs.
PharmaDrug (BUZZ)is up 14.29 per cent and is trading at C$0.12 at 1:03 pm EST.