WD-1905 - A First LD Product for Treatment of Early Morning “OFF”

"Early Morning Off” is the most common, and often, the first motor complication of PD. It is perceived at awakening after a nightlong treatment-free period. Meanwhile, sleep disturbances are common in PD, with nocturnal akinesia being one of the most burdensome.  Quality sleep may improve "Early Morning Off”. 

There is still an unmet-medical need for a treatment of "Early Morning Off” and sleep disturbances caused by nocturnal akinesia as well.

WD-1905 is a proprietary controlled-release tablet that is designed for oral administration at bedtime to provide constant release and well absorbed at UGIT, thereby providing LD plasma concentration above its therapeutic level at awakening.

WD-1905 can be administered at bedtime by PD patients themselves to wake up at the “ON” state, without any awaiting time from “OFF” state to “ON” state after administration of medicine, which greatly improves the patients’ quality of life. WD-1905 is a first LD product for treatment of "Early Morning Off”. 

A pharmacokinetic study was conducted with healthy volunteers under FDA’s IND. As shown in the following graph, LD plasma concentration was increasing gradually after administration at bedtime, reached maximum at 6hrs post-dosing and remained above 50% of Cmax for additional 2.5 hrs (Figure 7). A pharmacodynamic study with PD patients is ongoing.


Figure 7. Pharmacokinetic profiles of LD plasma concentrations after dosing of WD-1905