XSPRAY PHARMA AB The current formulation has undergone scale-up in the manufacturing process, stability testing, and has been tested in four clinical studies. External experienced pharmacokinetic experts have, with existing clinical data, calculated that with a 30 percent reduction in dose, the product should be bioequivalent to Sprycel®. Human bioequivalence studies confirms that the formulation:
- can be used simultaneous with omeprazole without affecting the absorption of dasatinib, which enables treatment of ulcer at the same time as the patient receives cancer treatment
- gives an even absorption of dasatinib without the number of low uptake outliers related to previous studies with Sprycel®
- can be administrated with a lower dose, which could lead to fewer side effects
“Our product is designed to improve the quality of life for patients with acute lymphocytic leukemia (ALL) and chronic myeloid leukemia (CML). I am convinced that our version, which is more soluble, bioavailable, gastric pH independent, and has a lower variability will lead to oncology physicians seeing improvements to both safety and efficacy. The application for market approval for our product will be submitted in accordance with the 505(b)(2) regulatory pathway”, says Per Andersson, CEO of
HyNap-Dasa 505(b)(2) will be tested against Sprycel® at a 30% lower dose in a pivotal bioequivalence study. If results are positive, a 505(b)(2) NDA submission is expected during H2 2021.
In 2020 Sprycel® sold worldwide for
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