Peter Milner M.D., CEO, said, "As a result of cooperative interactions between Renexxion management and the FDA, the agency formally dropped its requirement for preapproval CV safety outcome studies so that there is now a clear pathway to approval in CIC, the largest functional GI market. By agreement with the FDA, the additional 2000 total further exposures in two randomized clinical trials would be NDA-enabling. This path to approval is consistent with some of the other recently approved drugs in constipation indications and is familiar to large pharmaceutical companies."
About naronapride – Potential best-in-class blockbuster for unmet GI indications
No safe and effective GI motility agent has been approved since cisapride (Propulsid®) and tegaserod (Zelnorm®), which each sold over $1Bn annually, were withdrawn over 10 years ago due to cardiac safety concerns.
Naronapride was engineered to avoid any such cardiac safety risk. Its oral formulation serves large unmet needs in CIC, IBS-c, PPI-resistant GERD and GP. Additionally, an intravenous (or single dose oral solution) formulation could be used for unmet ICU and ventilator unit needs, including enteral feeding intolerance (EFI), acute GP, short bowel syndrome (SBS) and post-operative ileus (POI) where no approved treatments are available affecting millions of Americans.
Renexxion is a privately held biopharmaceutical company committed to delivering new drugs to patients with GI motility disorders.
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/renexxion-achieves-positive-fda-guidance-for-phase-3-ready-gi-drug-naronapride-300363946.html