Reformulated Metronidazole Granted Orphan Drug for CDI in Children
Appili Therapeutics announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation for ATI-1501 (metronidazole) for the potential treatment of Clostridium difficile infection (CDI) in children.
ATI-1501 is a taste-masked reformulation of metronidazole. For most children, metronidazole tablet is highly unpalatable due to its bitter taste. This reformulation has the potential to improve compliance rates in children in need for a safe and effective treatment for CDI.
The company intends to initiate clinical trials for ATI-1501 by 2017.
For more information visit Appilitherapeutics.com.