The FDA’s fast track programme is designed to facilitate the development and accelerate the review of new drugs intended to treat serious or life-threatening diseases and that show potential to address an unmet clinical need.
MuDelta, which is currently in Phase II clinical trials, is a novel mu-opioid receptor agonist and delta-opioid receptor antagonist in development for the treatment of diarrhea-predominant irritable bowel syndrome.
Early pre-clinical and Phase I clinical data of MuDelta indicate that this drug may provide effective relief for both pain and diarrheal symptoms of IBS-d, without causing constipation which is usually seen with mu receptor agonists.
Diarrhea-predominant irritable bowel syndrome or IBS-d is characterised by chronic abdominal pain and frequent diarrhea, and it affects approximately 12 million people in the US.