Are Needle-Free Injections a Useful Alternative for Growth Hormone Therapy in Children? Safety and Pharmacokinetics of Growth Hormone Delivered by a New Needle-Free Injection Device Compared to a Fine Gauge Needle

Abstract

The clinical safety, use and pharmacokinetics of a new needle-free device for delivery of growth hormone (GH) were compared with those of conventional needle injection devices. In an open-label, randomized, 4-period crossover study, 18 healthy adults received single subcutaneous injections of Genotropin administered by the Genotropin ZipTip needle-free device and by conventional injection. Bioequivalence was established between the devices. In a separate open-label, randomized, multicenter, 2-period crossover study, pediatric patients underwent 2-weeks Genotropin treatment administered by the Genotropin ZipTip and by a fine-gauge needle device (>95% used the Genotropin Pen). In total, 128/133 patients who were treated completed the study. Genotropin ZipTip was well tolerated and >50% of patients found no difference between the devices for all parameters assessed. After study completion, >20% patients preferred to continue using Genotropin ZipTip. Although statistical analyses demonstrated superiority of the Genotropin Pen versus Genotropin ZipTip for bleeding, pain, soreness, and bruising, Genotropin ZipTip was considered to provide a safe and bioequivalent alternative to needle injection.

Clinical Evaluation of the Needle-free Injection System VISION for Growth Hormone Therapy in Children

“…Several studies have been carried out comparing pharmacokinetic and pharmacodynamic characteristics of needle-free systems with traditional needle injection (5,6,7,8,9). These studies support the use of jet injection as a viable alternative to the traditional injection pens with needles.…”

Systematic Review of the Clinical Effectiveness of Genotropin (Somatropin) in Children with Short Stature

“…Only two studies gave specific details of randomisation 44,46 , and while two studies were double-blinded 51,60 , allocation concealment was not stated in the majority of trials. Indeed, 10 were open-label studies 40,45,46,[55][56][57]59,62,66,67 . Study design was also heterogeneous between trials, consisting of either Genotropin dose comparisons 41,43,44,53,56,57,59,62,[65][66][67] or Genotropin compared with an unspecified control 40,42,49,50,53,58 , placebo 51 , no treatment 20,41,47,52,[54][55][56][59][60][61][62][63][64]67 or another drug such as Sonomit ® (ubiquinone Q10) 48 , Omnitrope ® (GH) 46 or low-dose oestrogen (ethinyloestradiol) 29 .…”

“…Ethinyloestradiol was used either alone or in combination with Genotropin, as a comparator to Genotropin alone 29 . One study compared methods of Genotropin administration with either a ZipTip™ device or conventional needle 45 . Study durations ranged from four weeks JOURNAL OF PEDIATRIC ENDOCRINOLOGY & METABOLISM to the population being followed until final height.…”

“…Total number of RCTs reporting data for the different outcomes.Of the 30 RCTs remaining in the review, three investigated the effect of Genotropin in children with GHD[44][45][46] , one in children with TS 29 , 12 in children withPWS 20,[40][41][42][47][48][49][50][51][52][53][54] and one in children with CRI (Figure 2)…”

Formulations and Technologies in Growth Hormone Delivery

“…The needle-free injector was shown to be safe and bioequivalent. Thus, after the study, more than 20% of the patients preferred to keep on using it [53].…”