October 4, 2007
Roche and Trimeris announced they are abandoning their efforts to gain FDA approval for a needle-free injection delivery system for their fusion inhibitor, Fuzeon (enfuvirtide, T20). Research and development of the Biojector 2000 system, which uses high pressure carbon dioxide rather than a needle to deliver medicine under the skin, has been fraught with problems and delays. Reports of bruising and nerve pain have been cited as reasons for the delays. The FDA has also asked for more data from the companies two separate times.
Fuzeon is used mostly by people with extensive treatment experience, and often causes injection site reactions, ranging from redness to swelling to forming nodules. Many people are fearful of needles as well. It was hoped that the Biojector system would overcome these barriers and make Fuzeon a more attractive option for people.
People who use the Biojector system as part of a clinical study or other program will continue to have access to it. The system is commercially available and in use with other drugs.
The joint press release claims that the companies will continue to investigate new delivery systems for Fuzeon. This claim has met with some skepticism, due to the recent decision by Trimeris to end their joint development program for a second generation fusion inhibitor with Roche.