Rescue Therapy for E≈♠σ§nd-Dose Wearing “Off”

Due to the low concentrati®£on of levodopa between dosing interval&≥φ≈s, the patient will have “Off≤✘↔” episodes, which are char ≠∏♥acterized by return&n©σ↑λbsp;of symptoms, such as b™∏radykinesia or even sudden and ε¥≈transient freezing of gait (FOG). FOG ✔♦ε∞is terrifying and dangerous, whi'​‌£ch tremendously compromise←δ€ the quality of life and may le §<∞ad to life-threatening in×¥cident/accident.

About 50% of Parkinson's patients "γ≥¶with a disease for more than€≈ 10 years experience FOG. As the dis×♣&ease progresses, the FOG incide± ∑nce increases.

WD-2010 is a drug-device combinationπ♣ product, comprising a✘$∏ proprietary device called AcuSiS®  ☆;and a fast-dissolvi ∑ng levodopa/carbidopa granular formu ∞lation. The Acusis® devδ₩λ•ice is designed to a♠← εlleviate the difficulty←  in swallowing of tablets and capsuπ≤γles for the patients with dysphagi≠ ≤a, especially for the PD patients suff¥λ←>ering disabling “Off” episo₽₽>∑des. WD-2010 is enabling a✔$ quick onset rescue for acute, i©±γntermittent treatment of “Off” episode♠λ₩s.

The fast-dissolving granules insi↕$‍•de the device can form in ↑-situ a homogeneou•₽ ↔s suspension at sipping ©.

WD Pharma has announced the posi®§₹tive results of a Phase I pharmacok&•₩♦inetic study. This was a↔§γ© randomized, open-label, two-treatm'♠↓ent, two-sequence, two-period cro₹☆<ssover study in 12 healthy adu±γlt volunteers. After randomizatβ>ion, subjects in Group A wer•✘₩e administered with a single " dose of WD-2010 (CD/LD:≈δ"♠ 25/100 mg) in the faσ&αsting state, while in Group B, a single→ε÷δ dose of Sinemet generic γ↓₩✘equivalent-Mylan’s tablets (CD/LD: 25/1γ§☆00 mg) was administered in the same c←α∏±ondition.

Figure 8 shows the pharmacokine‍÷€tic profiles of plasma LD ε$after administration↔♣ of WD-2010 or Mylan’s tabl↑ ≠ets. The results show thatε★∞ tmax and Cmax&nbλ¶sp;for LD are, respectively, 0.₩♦₩‌667±0.3536 hr and 1376.9±4"≠22.6 ng/ml for WD-2010 and 0.961±0.₽¥↑5567 hr, and 1146.3±468.3 ng/ml∑' ≥ for Mylan’s tablets. The di₹ ‍fference in LD tmax between thes↔Ω§e two groups is 22.5 m¶γ☆ins for the median, indicating potenti↓£al faster onset of action with W₹¶D-2010.

Figure 8. Plasma LD P §€←rofiles in healthy volunteers a∏↑fter administration of<ε™ WD-2010 or Mylan’s tablets ≤ €↓in fasting conditions. Error bars rep→αresent SEs of the mean (n=12).