Tanabe Pharma Report the EC Approval of Onerji for Parkinson’s Disease (PD)
Shots:
- The EC has approved Onerji (levodopa/carbidopa) infusion for advanced PD pts with uncontrolled motor fluctuations. The therapy is being developed by its wholly owned subsidiary, NeuroDerm
- Approval was based on the global P-III (BouNDless) trial, which demonstrated Onerji + supplemental oral LD/CD significantly increased ON time without troublesome dyskinesia and reduced OFF time vs immediate-release oral LD/CD. Favourable long-term safety and tolerability results were also observed in the late P-II (BeyoND) study
- Onerji is a 24-hour continuous SC liquid LD/CD infusion therapy for advanced PD pts with motor fluctuations. Delivered via a portable infusion pump system, it is designed to maintain stable LD plasma concentrations and improve PK profiles
Ref: X4 Pharmaceuticals | Image: X4 Pharmaceuticals | Press Release
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