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FDA grants fast track designation to IV cannabidiol for neonatal hypoxic/ischemic encephalopathy
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GW Pharmaceuticals recently announced that the FDA has granted fast track designation to an intravenous form of cannabidiol for the treatment of neonatal hypoxic/ischemic encephalopathy.
Additionally, the European Medicines Agency has granted orphan designation for the same product to treat perinatal asphyxia, for which the manufacturer has already received orphan drug designation from the FDA.
An acute or sub-acute brain injury due to asphyxia during the birthing process, neonatal hypoxic/ischemic encephalopathy occurs in 1.5 to 2.8 per 1,000 births in the United States — of these children, 35% are estimated to die in early life while 30% could suffer from permanent disability.
Currently, there are no approved therapies for neonatal hypoxic/ischemic encephalopathy or perinatal asphyxia. Standard of care treatment for perinatal asphyxia patients includes inducing whole-body hypothermia, but is only available in specialized neonatal ICUs and must be initiated within 6 hours of birth.
However, even with treatment, there remained a significant rate of morbidity and mortality; examination of available data demonstrated a 27% death rate, and among patients who survived treatment, 28% exhibited major neurodevelopment issues while 26% developed cerebral palsy.
“GW believes that cannabinoids may have a potentially important role in the treatment of high need pediatric neurologic conditions. As a result, we have developed a proprietary intravenous CBD formulation specifically for use in this most vulnerable of patient populations, newborn infants with NHIE,” Justin Gover, CEO of GW Pharmaceuticals, said in a press release. “As there are no current treatment options beyond induced hypothermia for the affected newborns, there exists a dramatic need to develop new and effective therapies aimed at preventing acute brain damage and enhancing long-term brain repair.”
The FDA provides fast track status to facilitate the development of new products for serious or life-threatening conditions that demonstrate the potential to address unmet medical needs, with the goal of getting important new products to patients earlier. Fast track status will also allow the company to work closely with the FDA to expedite the review of aspects of the pharmaceutical cannabidiol program to improve the efficiency of product development.