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Xspray Pharma commences study with improved version of dasatinib

Xspray Pharma (Nasdaq Stockholm: XSPRAY) announced today that a bioequivalence study with the improved version of dasatinib has commenced. The objective of the study is to demonstrate that a lower dose strength of Xspray Pharma’s improved version of dasatinib is bioequivalent to a higher dose strength of the original drug Sprycel®. The study is being conducted with a previously used formulation of Xspray Pharma’s amorphous version of dasatinib. The findings will form the basis of an application for market approval in the US under the 505(b)(2) regulatory pathway. The preliminary findings from this study are expected in the third quarter of 2021.

“I am pleased that we are initiating this bioequivalence study as planned. This product candidate that has the potential to improve the therapy for a cohort of cancer patients in a high-value field where no new or improved drugs have been registered for many years. In addition, we have tested this formulation A in previous studies and can better predict the findings compared to the studies that have been based on completely new untested formulations,” says Per Andersson, CEO of Xspray Pharma.

Xspray Pharma’s improved version of dasatinib for the treatment of acute lymphoblastic leukemia (ALL) and chronic myeloid leukemia (CML) and is designed to enable therapy with proton-pump inhibitors (PPIs) such as omeprazol which should be avoided with the original product. Xspray Pharma’s product will be administered at a lower dose strength compared with Sprycel® but with the same availability.

Bioequivalence studies with Xspray Pharma generic product candidate, formulation C, where the objective is to demonstrate bioequivalence with Sprycel®, will be initiated this summer. The findings will form the basis of an application for market approval in the US under the ANDA regulatory pathway.

Source: MFN
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