FDA Grants Fast Track Status to IBS-D Treatment

The Food and Drug Administration (FDA) has granted Fast Track designation to ORP-101 (OrphoMed), an investigational treatment for irritable bowel syndrome with diarrhea (IBS-D).

ORP-101 is a peripherally active partial agonist of the μ opioid receptor and antagonist of the κ opioid receptor. It is designed to mitigate colonic hypersensitivity and associated motility dysfunction in IBS-D.

In animal models, ORP-101 consistently suppressed general and colon-specific hyperalgesic signals without CNS penetration and without constriction of the sphincter of Oddi. 

“Our goal is to continue to advance ORP-101 into Phase 2 by the end of 2018,” said Gary Phillips, MD, OrphoMed’s President and CEO.

Rates of IBS vary depending on diagnostic criteria but recent studies have suggested that the syndrome affects roughly 11% of the US population (Canavan et al. 2014; Hungin et al 2005). 

For more information visit OrphoMed.com.