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news.The US Food and Drug Administration (FDA) has granted fast track designation for GW Pharmaceuticals' proprietary intravenous form of cannabidiol (CBD) to treat Neonatal Hypoxic-Ischemic Encephalopathy (NHIE).
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Additionally, the European Medicines Agency (EMA) has granted orphan designation for the same product to treat perinatal asphyxia, an alternate term that describes the same condition as NHIE, for which the company has already received orphan drug designation from the FDA.
Currently, there are no approved medicines in Europe or the US specifically indicated for NHIE or perinatal asphyxia.
GW Pharmaceuticals chief executive officer Justin Gover said: "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. 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.
"GW is now working towards the launch of a clinical development program in this important medical condition towards the end of this year."
Both NHIE and perinatal asphyxia are forms of acute or sub-acute brain injury due to asphyxia caused during the birth process and results from deprivation of oxygen during birth (hypoxia).