Xspray Pharma initiates pivotal registration studies with HyNap-Dasa for the market approval application in the United States
Regulatory press release 2020-05-29
Xspray Pharma AB (Nasdaq Stockholm: XSPRAY) today announces the start of the pivotal clinical bioequivalence studies with HyNap-Dasa. The studies are conducted on healthy volunteers with the objective to demonstrate that HyNap-Dasa is bioequivalent to the original drug Sprycel® (dasatinib).
The bioequivalence studies consist of two studies, where the first one, starting today, is conducted on fasted healthy volunteers. The second study, starting next month, is conducted on non-fasted healthy volunteers. In both studies, HyNap-Dasa bioavailability is compared to the original drug Sprycel®. The preliminary results from the two studies are expected during the third quarter 2020.
"The initiation of the pivotal clinical trials marks a major milestone for Xspray and for our HyNap-Dasa product candidate," says Per Andersson, CEO Xspray. “HyNap-Dasa has in previous clinical studies shown positive results and we now look forward to see the clinical outcome this time as well, and take a big step closer to submitting our first application for market approval in the US."
The results of the two clinical trials together with the results of the ongoing stability studies will form the basis of the company’s ANDA application for market approval in the USA.