Xspray Pharma has initiated studies with generic version of dasatinib, HyNap-Dasa ANDA
Press release 2021-08-06
Xspray Pharma (publ) (Nasdaq Stockholm: XSPRAY) announced today that the pivotal bioequivalence studies have been initiated with the modified tablet formulation of the generic product candidate with dasatinib, HyNap-Dasa ANDA "C".
The bioequivalence studies are being conducted in fed and fasting healthy volunteers. The purpose of the studies is to achieve bioequivalence for HyNap-Dasa ANDA “C” compared with the reference product, Sprycel® (dasatinib). The results from both studies are expected in H2 2021.
“It is extremely gratifying to have initiated the bioequivalence studies with the generic product candidate with dasatinib, HyNap-Dasa ANDA “C”. We have modified the formulation to compensate for Sprycel’s low absorption in the body under fasting conditions, where our previous formulations had too high absorption in comparison to the reference product,” says Per Andersson, CEO of Xspray Pharma.