Xspray Pharma AB through its proprietary HyNap? technology, announced the results from drug interaction studies demonstrating that DASYNOC?s (DASYNOC CO-PPI Study) uptake into blood following oral dosing is not altered by the concomitant administration of omeprazole, a commonly prescribed PPI, while a significant reduction in the uptake of SPRYCEL (SPRYCEL CO-PPI Study) was observed with the use of omeprazole. Xspray has demonstrated that in the DASYNOC CO-PPI Study, DASYNOC?s uptake into blood was not affected 10 hours after taking omeprazole (107 % of intended AUC0-24h and 86% of intended Cmax).

However, in the SPRYCEL CO-PPI Study, the uptake of SPRYCEL was significantly reduced 10 hours after taking omeprazole (only 12% of the intended AUC0-24h and 4% of the intended Cmax). Previous studies supporting the approval of SPRYCEL demonstrated that administration of a single 100 mg dose of SPRYCEL, 22 hours following a 40 mg dose of omeprazole, reduced the mean AUC of dasatinib to 57% and the mean Cmax to 58% of the intended values without PPI. Despite labeled avoidance of coadministration of SPRYCEL with PPIs2, PPIs are used concomitantly in nearly half of all CML patients taking TKIs.1 The SPRYCEL CO-PPI Study data show that subjects received only 12% of the intended dasatinib dosage.

This may potentially increase their risk of disease progression and death1. SPRYCEL was approved in 2006 by the FDA and is the market leading branded product that revolutionized the treatment of CML. However, the crystalline formulation of dasatinib in SPRYCEL results in a low, pH-sensitive, and highly variable intestinal absorption that may jeopardize the optimal and anticipated therapeutic response.3?6 In contrast, DASYNOC?s amorphous, non-crystalline, formulation results in higher solubility, improved dissolution and pH independent bioavailability allowing patients to receive the full benefits of dasatinib therapy.