"Early Morning Off” is the ©✔↔most common, and oft™φ≤♣en, the first motor c"&✘omplication of PD. It≠★§ is perceived at awakening after a nighβ↓ tlong treatment-free period. MΩ±eanwhile, sleep disturba☆±¶δnces are common in PD, wi↓↓¥∏th nocturnal akinesia being oε∞★ne of the most burdensome. Qualiεπ≈ty sleep may improve "Early M≤↔↕orning Off”.
There is still an unmet-≤←medical need for a treatment ¶ of "Early Mornin↑ ♣g Off” and sleep disturbances caused∞≠¶ by nocturnal akinesia as well.
WD-1905 is a proprieta∏→ry controlled-releaseα♥∞ tablet that is designed for oral admi"Ω↑nistration at bedtime toδ$ provide constant rel≤₹ease and well absorbed at UGIT, the™reby providing LD plasma concen✘π♥tration above its thera×®§peutic level at awakening.
WD-1905 can be administered at bedtime ε←by PD patients themselves ₹ to wake up at the “ON” state, with↕π ₩out any awaiting time from “OFF” state β≈≥to “ON” state after administration of medicine, whic•©h greatly improves the patients’ qu$≥₽≥ality of life. Wλ™D-1905 is a first LD produλ←ct for treatment of "Early M£&orning Off”.
A pharmacokinetic sγπtudy was conducted with healthy₹↑ volunteers under FDA’s IND. β± As shown in the follow '↔¥ing graph, LD plasma÷&®' concentration was increasi☆★ng gradually after administration at ∏>bedtime, reached maximum atδ ≤♥ 6hrs post-dosing and remain±πed above 50% of Cmax&nb←§'♠sp;for additional 2.5 hrs&n₽&♣bsp;(Figure 7). A pha♦↑β¶rmacodynamic study with PD patients γ∞₹is ongoing.
Figure 7. Pharmacokinetic profile©s of LD plasma concenα♠★trations after dosing of Ω ≠WD-1905
