Objective: To assess the efficacy and safety of Rotigotine extended-release microspheres (LY03003) in patients with early Parkinson’s disease

Background: Treatment that provides a continuous flow of dopamine and thus can mimic normal physiological dopamine stimulation to improve motor control for patients. Weekly intramuscular injection also has the advantage of simplifying treatment regimen, improving compliance, and reducing gastrointestinal dysfunction.

Method: This was a phase 3, randomized, placebo-controlled, double-blind trial enrolled 294 subjects aged 30 or older and diagnosed with PD within 5 years. Participants were randomized in a 1:1 ratio to receive a weekly intramuscular injection of 56mg LY03003 (n=147) or placebo (n=147) for up to 24 weeks. The primary outcome was the change in the UPDRS subtotal scores of parts Ⅱ and Ⅲ from baseline to the end point. The secondary outcomes included responder rate (defined as ≥20% decrease in subtotal score of UPDRS part Ⅱ and Ⅲ, and changes in scores of UPDRS Ⅱ or Ⅲ, CGI, and PDQ-8.

Results: The study has demonstrated a statistically significant improvement in LY03003 group than placebo group in UPDRS subtotal scores of Ⅱ+Ⅲ (-11.8 vs. -5.6, P <0.001), UPDRS (Ⅱ+Ⅲ) responder rates (67.7% vs 38.5%; P＜0.001) and CGI-GI Scale (74.8% vs 54.2%; P＜0.001). Significant differences were also observed between LY03003 and placebo groups in the PDQ-8, and CGI-SI Scales. Most treatment-emergent adverse events (TEAEs) were mild or moderate. Serious adverse events occurred relatively equal between the LY03003 group (7, 4.8%) and placebo group (4, 2.7%).

Conclusion: The results have demonstrated intramuscular injection of Rotigotine extended-release microspheres weekly can provide lasting improvement in symptoms and quality of life of PD patients with good safety and tolerance.

Change in UPDRS Subtotal Scores of Part II and III

Change in UPDRS Scores Part III

References: ClinicalTrials.gov Identifier: NCT 04571164.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/efficacy-and-safety-of-rotigotine-extended-release-microspheres-in-early-parkinsons-disease/