PRODUCTS: Alprazolam

Alprazolam has been formulated in Antares’ proprietary advanced transdermal delivery (ATD™) system for the treatment of anxiety, generalized anxiety and panic disorders. This transdermal gel product achieves suitable plasma levels of alprazolam, comparable to oral treatment, when formulated as a once daily topically applied gel dose form. Our Alprazolam ATD gel is a simple, easy to use formulation that avoids ‘peaks and troughs’ observed with immediate release tablets. It also avoids the significant food effect observed in sustained release tablets, in addition the gel formulation is both chemically and physically stable. Permeation across skin in vitro and absorption across rabbit skin in vivo, have been achieved successfully. Further, Phase I pharmacokinetic studies in humans showed therapeutic plasma concentrations of alprazolam are achieved after one daily application. Antares’ alprazolam ATD gel offers a convenient dose form providing consistent plasma levels that will prevent breakthrough anxiety. As a short or long term alternative for the management of anxiety, alprazolam ATD gel may also address dependence issues, meaning patients can potentially be titrated to the lowest dose possible. Regulatory approval of Antares’ alprazolam gel formulation will provide patients with continuous therapeutic plasma levels minimizing hepatic first pass metabolism, and potential drug interactions, with the convenience of a once daily regimen.