A new soluble formulation of the human recombinant growth hormone "Norditropin Simplex": Results of a clinical study of children and adolescents with somatotropic deficiency in Russia

Abstract

Two formulations of the human recombinant growth hormone Norditropin (Novo Nordisk, Denmark), namely the liquid dos­age form Norditropin Simplex and the lyophilized dosage form Norditropin PenSet, by using 2 different pen-syringe systems (NordiPen and Nordiject, respectively) were studied in an open randomized crossover study of children with somatotropic defi­ciency. The new soluble formulation of growth hormone Nord­itropin Simplex was developed due to a need for a liquid, stable dosage form that requires no mixing and permits simple and easy- to-use daily injections. Norditropin Simplex is the first liquid growth hormone drug in a milligram dose, which meets the new WHO standards and the European Pharmacopoeia. The purpose of the study was to evaluate the capacities of the new liquid growth hormone formulation Norditropin Simplex, which re­quires no mixing, the pen-syringe NordiPen versus the lyophi­lized growth hormone formulation Norditropin PenSet and the pen-syringe Nordiject in children with somatotropic deficiency. The efficiency and safety of Norditropin Simplex used in the study group of children were also evaluated. Eleven patients with somatotropic deficiency received daily injections of Norditropin Simplex, 5 mg/10 mg, or Norditropin PenSet 12 for 6 weeks, the drug being replacedfor the following 6 weeks. Following 12 weeks of therapy, the preference of one formulation to the other was as­sessed by a questionnaire filled in by a patient or his/her parents. The patients who preferred Norditropin Simplex received an ad­ditional treatment with this drug for as long as 21 months. Ten of the 11 patients noted the advantage of Norditropin Simplex and Nordi pen over Norditropin PenSet and Nordiject continued treatment with the former drug for as long as 21 months. One pa­tient found no significant differences in the use of both dosage forms, but he preferred to continue therapy with Norditropin Sim­plex after a 12-week comparison period. Norditropin Simplex was ascertained to show a high growth-stimulating effect and safety, painless injections, and the easiness of using the pen-sy­ringe NordiPen in children and adolescents with somatotropic deficiency.