US FDA approves needle-free injector for Tev-Tropin.

The FDA has approved Tev-Tropin (somatropin [rDNA] for injection, from Teva) for administration by needle-free injection. The needle-free device, by Antares Pharma, will be marketed by Teva as the Tev-Tropin Tjet Injector system.

The injector system has been available in Japan for some time under the name Vison.

“Abstract. The aim of this study was to compare the therapeutic effects of rhGH administered either by subcutaneous needle-injection (pens) or subcutaneous needle-free jet-injection (VISION®). Furthermore, a survey was carried out after using VISION® for 12 mo. A needle-free injection group consisting of 18 subjects (11 males and 7 females, mean age 5.87 ± 2.05 yr at the start of hGH therapy) who have not used pen injectors to date, were allowed to use VISION® in their third to fifth years of GH therapy. In addition, a group of 8 subjects who had been using pen injectors at our clinic (6 males and 2 females, mean age 6.54 ± 2.78 at the start of GH therapy) was monitored as a control. The results indicate that there are no significant differences between the mean growth rates, growth rate SD scores or height SD scores when comparing injection devices. Furthermore, the survey of VISION® revealed that 70% of the subjects found it slightly or not painful at or after injection, 70% found VISION® very easy or easy to use, and 80% found the weight of the device appropriate. All subjects expressed a desire to continue using VISION® in the future. Our results suggest that there are no problems with the effectiveness of hGH treatment with VISION®, a needle-free jet-injection device and that VISION® is an effective device for children who have an aversion to needle injection.”

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