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Home 🌿 Medical Cannabis News 🌿 FDA backs cannabis-based medicine for in-danger newborns 🌿FDA backs cannabis-based medicine for in-danger newborns
Cambridge biomedical innovator, GW Pharmaceuticals, has won fast track designation from the US FDA for a potential treatment for babies deprived of oxygen during childbirth – a problem that can lead to brain damage and death.
NASDAQ-quoted GW has received FDA support for a proprietary intravenous form of cannabidiol (CBD) to treat Neonatal Hypoxic-Ischemic Encephalopathy, or NHIE.
The European Medicines Agency has granted orphan designation for the same product to treat perinatal asphyxia, an alternate term that describes the same condition as NHIE, for which GW has already received Orphan Drug Designation from the FDA.
There are currently no approved medicines in Europe or the US specifically indicated for NHIE or perinatal asphyxia.
Justin Gover, GW's CEO, said: “GW believes that cannabinoids may have a potentially important role in the treatment of high need paediatric neurologic conditions. As a result, we have developed a proprietary intravenous CBD formulation specifically for...
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