In the approvable letter the FDA has requested additional information from the ongoing WAND study, a randomized, open-label, two-way, crossover study assessing the tolerability of the B2000 device for administration of Fuzeon.
Fuzeon is the only entry inhibitor available for the treatment of HIV and is currently approved for administration with a needle and syringe. The B2000, made by Bioject Medical Technologies, is a needle-free, CO2-powered injector that disperses liquid medication beneath the skin.
Roche and Trimeris filed a supplemental new drug application in May 2005 based on data from a single-dose pharmacokinetic study of Fuzeon administered by a nurse via the B2000 needle-free device, compared to standard needle-syringe administration.
In August 2005, Roche and Trimeris initiated the WAND study, an eight-week trial designed to assess patient acceptance and experience of Fuzeon administration via the B2000 needle-free device compared to the standard needle and syringe. The primary endpoints of this study are tolerability and injection site reactions. Final data from the trial are expected in the second half of 2006.