In the clinical study, Orexo compared its new nasal powder spray with a current liquid nasal spray in 13 healthy volunteers. The study showed that the uptake of desmopressin into the blood stream was three times higher than that of the current liquid nasal spray, with no delay in time to reach maximal plasma concentration. The drug concentrations in the blood showed lower variability compared to the reference product. Reduced variability is essential for a reproduceable effect.
The study also showed excellent tolerance of both spray formulations and no unexpected adverse events. The study also included a sublingual tablet formulation. However, the bioavailability of desmopressin did not increase enough to reach the primary objective for the sublingual tablet formula.
Torbjorn Bjerke, president and CEO of Orexo, said: “We are pleased with the results of the study. Next step will be to seek a partner for the continued development of the nasal powder formulation of desmopressin.”