Treatment for genetic eating disorder receives orphan drug designation

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 Pharmaceuticals, said in a press release. “It underscores the urgent, unmet medical need for patients diagnosed with this disease and will benefit us as we continue to advance our program.”