FDA filing of T-20 sNDA for administration with a needle-free injection device
14 August 2005. Related: Antiretrovirals.
Roche and Trimeris announced on 18 July 2005 that the U.S. Food and Drug Administration (FDA) has accepted the filing of their sNDA to consider inclusion of information about the Biojector 2000 (B2000) needle-free injection device in the T-20 (enfuvirtide, Fuzeon) labeling. The filing is based on data from the T20-405 study, a single-dose, comparative pharmacokinetic study of T-20 administered via the needle-free device compared to standard needle-syringe administration. Results from this study were reported in the April 2005 issue of HIV Treatment Bulletin. [1]
The B2000 injection system, manufactured by Bioject Medical Technologies Inc., is a needlefree CO2-powered injector that disperses liquid medication through the skin. The B2000 has been available since 1996 to deliver subcutaneous and intramuscular injections and has been used in vaccine delivery, chronic therapy and other settings, delivering millions of injections.
Source: Roche Press Release
For more information on Biojector:
Biojector Needle Free Injection System
http://www.bioject.com
Reference:
- Needle-free injections for T-20 in US. HTB April 2005.
http://www.i-base.info/htb/7141/