GW Pharmaceuticals has recently stated that the FDA has allowed fast track appointment to a form of cannabidiol for treat neonatal hypoxic/ischemic encephalopathy that flows through the veins. Orphan appointment for the same product to treat perinatal asphyxia was also approved and the manufacturer now officially has orphan drug designation from the FDA.

Because of asphyxia during the birthing process, a brain injury occurs and as a result, neonatal hypoxic/ischemic encephalopathy presents itself in 15 to 28 per 10,000 births in the United States. 35% of these children have a slim chance to grow past early life while 30% potentially suffer from permanent disability.

At the moment, no approved therapies for neonatal hypoxic/ischemic encephalopathy or perinatal asphyxia exist. Standard procedure for perinatal asphyxia patients involves forcing whole-body hypothermia, but is not available to everyone and has extremely slim time rates – up to six hours after birth. Even with treatment, there are still high death rates. Data demonstrated a 27 percent mortality, and among survivors, 28% experienced neurodevelopment issues and another 26% demonstrated 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 is consenting fast track status to allow the developments for life-threatening circumstances that have the potential to fill unmet medical needs, with the goal of getting vital products to patients quicker. This will also permit the company to work with the FDA to quicken the review of various sectors of the cannabidiol program to expedite developments.


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