MENLO PARK, Calif., Nov. 16, 2016 /PRNewswire/ -- Renexxion today announced positive guidance on the design of the final pivotal trials required for NDA filing for naronapride, a potentially best-in-class 5HT-4 agonist for treatment of GI motility disorders.
At a recent meeting of the FDA's Division of Gastroenterology and Inborn Errors Products (DGIEP), and the Center for Drug Evaluation and Research's (CDER) new Safety Outcomes Trials (SOT) Subcommittee, it was agreed that the necessary safety database for naronapride development for chronic idiopathic constipation (CIC) and other functional GI disorders does not require statistical powering for cardiovascular outcomes. Furthermore, Renexxion was advised that two randomized, blinded placebo-controlled clinical trials of 1000 subjects each of 12 weeks duration in this indication would be sufficient for filing of an NDA for naronapride. The safety trials would be limited to 12 months total exposure in these 2000 subjects in addition to the 982 subjects already exposed in the four positive Phase II studies.
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agent has been approved since cisapride (Propulsid®) and tegaserod (Zelnorm®), which each sold over $1Bn annually, were withdrawn over 10 years ago due to cardiac safety concerns.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.
About Renexxion:
Renexxion is a privately held biopharmaceutical company committed to delivering new drugs to patients with GI motility disorders.
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At a recent meeting of the FDA's Division of Gastroenterology and Inborn Errors Products (DGIEP), and the Center for Drug Evaluation and Research's (CDER) new Safety Outcomes Trials (SOT) Subcommittee, it was agreed that the necessary safety database for naronapride development for chronic idiopathic constipation (CIC) and other functional GI disorders does not require statistical powering for cardiovascular outcomes. Furthermore, Renexxion was advised that two randomized, blinded placebo-controlled clinical trials of 1000 subjects each of 12 weeks duration in this indication would be sufficient for filing of an NDA for naronapride. The safety trials would be limited to 12 months total exposure in these 2000 subjects in addition to the 982 subjects already exposed in the four positive Phase II studies.
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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.
About Renexxion:
Renexxion is a privately held biopharmaceutical company committed to delivering new drugs to patients with GI motility disorders.
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SOURCE Renexxion
