Xspray Pharma (Nasdaq Stockholm: XSPRAY) announces today that the new bioequivalence studies with a slightly modified formulation of HyNap-Dasa has started. The studies are conducted on healthy volunteers with the objective to demonstrate that HyNap-Dasa is bioequivalent to the original drug Sprycel® (dasatinib) in order to then be able to submit an application for market approval in the USA, so called ANDA. The preliminary result from this study is expected at the beginning of the second quarter.
The bioequivalence studies consist of two studies, where the first one that has started now, is conducted on fasted healthy volunteers. The second study, starting in early February, is conducted on non-fasted healthy volunteers. In both studies, HyNap-Dasa bioavailability is compared to the original drug Sprycel®.
“Immediately after we received the results from the studies this autumn, we decided to develop new formulations of HyNap-Dasa to achieve bioequivalence. With this large market potential, we want to enter the market as soon as possible. The study with the first formulation, which is slightly modified, has now started. We have a second formulation which is more modified, with study start in the second quarter,” says CEO Per Andersson. “We expect to achieve a lower general absorption for this modified formulation than the results we received last autumn. This is to compensate for the fact that the original drug showed very low absorption in some subjects where our formulation did not.