GW - Neonatal Hypoxic-Ischemic Encephalopathy Treatment
From Healthcare Professionals - Research & Trials - Therapeutic Areas
NHIE is acute or sub-acute brain injury due to asphyxia caused during birth resulting from deprivation of oxygen during birth (hypoxia) as a result of a sentinel event such as ruptured placenta, parental shock and even increased heart rate. Hypoxic damage can occur to most of the infant’s organs, but brain damage is the most serious and least likely to heal, resulting in encephalopathy. This can later manifest itself as either mental retardation (including developmental delay and/or intellectual disability) or physical disabilities such as spasticity, blindness and deafness. The exact timing and underlying causes of these outcomes remains unknown but it is widely recognized that interventions need to be administered within six hours of hypoxic insult.
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Under an IND, GW has completed a Phase 1 trial in healthy volunteers for an intravenous CBD formulation in the treatment of NHIE. After consulting with the FDA on the most appropriate design for an efficacy and safety study in neonates, the Company has commenced a safety study of our intravenous CBD formulation in NHIE in neonate patients in the US. There are currently no FDA-approved medicines indicated for NHIE.
GW has received Orphan Drug Designation and Fast Track Designation from the FDA for CBD for the treatment of NHIE. GW has also received Orphan Drug Designation from the EMA for CBD for the treatment of perinatal asphyxia, an alternate term that describes the same condition.
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