Xspray Pharma commences study with modified formulation of HyNap-Dasa
22 January 2021 -

Swedish pharmaceutical company Xspray Pharma (STO:XSPRAY) announced on Friday the launch of new bioequivalence studies with a slightly modified formulation of HyNap-Dasa.

Xspray Pharma's leading product candidates, HyNap-Dasa and HyNap-Nilo, are stable amorphous versions of the blockbuster cancer drugs Sprycel (dasatinib) and Tasigna (nilotinib). HyNap-Dasa is being developed in two versions, a generic and an improved version. HyNap-Nilo is being developed as an improved version and has received orphan drug status from the US Food and Drug Administration (FDA).

The new studies are being conducted on healthy volunteers with the objective to demonstrate that HyNap-Dasa is bioequivalent to Sprycel, in order for the company to be able to submit an abbreviated new drug application (ANDA) in the United States. Preliminary results are expected at the beginning of the second quarter.

The first study involves fasted healthy volunteers, while the second study, due to start in early February, will involve non-fasted healthy volunteers.