All participants in Xspray Pharma studies have received their dose of generic version of dasatinib, HyNap-Dasa ANDA
Press release 2021-08-30
Xspray Pharma (publ) (Nasdaq Stockholm: XSPRAY) announces today that all participants have received their dose in the two bioequivalence studies with the generic product candidate of dasatinib, HyNap-Dasa ANDA.
The bioequivalence studies were conducted on fed and fasting healthy volunteers. The aim of the studies is to achieve bioequivalence for HyNap-Dasa ANDA compared with the reference product, Sprycel® (dasatinib). The studies used a modified formulation of dasatinib, called HyNap-Dasa ANDA formulation C. The results from both studies are expected in H2 2021.
“Our technology makes it possible for us to manufacture improved and generic versions of the PKI substances being marketed. Our improved version of dasatinib has already achieved bioequivalence and is ready to apply for market approval in the US. We are now looking forward to the results from our generic version. Due to Covid-19, the possible closure of facilities where the analyses are being conducted, may mean it takes longer to obtain the results compared with previous studies,” says Per Andersson, CEO of Xspray Pharma.