PSX1001 | PSX1002 | PSX2000 Series | Partners

Fluticasone monotherapies sold >$1 billion in 2010. Because of innate complex formulation challenges, no generic drug product is yet sold in regulated markets. New EU guidelines allow the approval of generic inhalation products by in vitro bioequivalence alone.

Prosonix has shown in vitro bioequivalence for PSX1001 in both MDI and DPI formulations in generically available devices. In addition, Prosonix has had engineered fluticasone API tested on a full scale formulation production batch with in vitro results showing it is equivalent to the currently marketed material.

The Company plans to develop this product rapidly in accordance with the new European guidelines in MDI the first instance and plans to submit in vitro bioequivalence data in 2013.