Preclinical Safety Results

Multiple preclinical safety studies have been conducted using P-188 NF in a number of animal species (mice, rats, dogs, rabbit and monkeys) and using a number of routes of administration, including subcutaneous dosing, These studies have confirmed suitable safety of P-188 NF for use in Duchenne muscular dystrophy.

Jason Celik

Jason Celik

4-week toxicity study with P-188 NF in rats using daily subcutaneous dosing followed by a 2-week recovery period
Summary basis for approval for NDA 21-148, Novo Nordisk’s NDA for Norditropin™, part 1, and summary basis for approval for NDA 21-148, Novo Nordisk’s NDA for Norditropin™, part 2

13-week toxicity study with P-188 NF in rats using daily subcutaneous dosing followed by a 4-week recovery period
Summary basis for approval for NDA 21-148, Novo Nordisk’s NDA for Norditropin™, part 1, and summary basis for approval for NDA 21-148, Novo Nordisk’s NDA for Norditropin™, part 2

Toxicity study with P-188 NF in rats (daily intravenous dosing for one month)
Magnusson G, Olsson T, Nyberg JA. Toxicity of Pluronic F-68. Toxicol Lett. 1986; 30:203-7.

Toxicity study with P-188 NF in rats (daily intravenous dosing for one month)
Duvinage C, Millecamps S, Sagnier A, Guffroy M, Sarsat J-P, Belin V. One-month intravenous toxicity studies of poloxamer 188 in Sprague-Dawley rats and in beagle dogs. Toxicology Letters 1996; 88(Supplement 1): 101.

4-week toxicity study with P-188 NF in dogs using daily subcutaneous dosing followed by a 2-week recovery period
Summary basis for approval for NDA 21-148, Novo Nordisk’s NDA for Norditropin™, part 1, and summary basis for approval for NDA 21-148, Novo Nordisk’s NDA for Norditropin™, part 2

13-week toxicology study with P-188 NF in dogs using daily subcutaneous dosing followed by a 4-week recovery period
Summary basis for approval for NDA 21-148, Novo Nordisk’s NDA for Norditropin™, part 1, and summary basis for approval for NDA 21-148, Novo Nordisk’s NDA for Norditropin™, part 2

Toxicity study with P-188 NF in dogs (daily intravenous dosing for one month)
Duvinage C, Millecamps S, Sagnier A, Guffroy M, Sarsat J-P, Belin V. One-month intravenous toxicity studies of poloxamer 188 in Sprague-Dawley rats and in beagle dogs. Toxicology Letters 1996; 88(Supplement 1): 101.

Toxicity study with P-188 NF in cynomologus monkeys (daily intravenous dosing for one month)
Duvinage C, Millecamps S, Sagnier A, Guffroy M, Sarsat J-P, Belin V. One-month intravenous toxicity studies of poloxamer 188 in Sprague-Dawley rats and in beagle dogs. Toxicology Letters 1996; 88(Supplement 1): 101.

Only published studies known or assumed to have been conducted under Good Laboratory Practices (GLP) conditions are listed. No research studies purporting to be safety studies have been included. There are additional proprietary, non-public studies that support these results.