The FDA has granted orphan drug designation to an intranasal potentiated oxytocin treatment for a rare genetic disorder that causes pathological eating disorders in adults and newborns.
Clinical-stage biopharmaceutical company Tonix Pharmaceuticals developed TNX-2900 for treating Prader-Willi syndrome, which causes pathological overeating in adults and a deficiency in suckling in newborns.
“Orphan drug designation by the FDA is an important milestone and further validates our efforts to investigate the utility of TNX-2900 for Prader-Willi syndrome,” Seth Lederman, MD, CEO of Tonix