Mitsubishi Tanabe Reports Initiation of P-III BouNDLess Trial in Patients with Fluctuating Parkinson’s Disease
Shots:
- The P-III BouNDLess study involves assessing of continuous carbidopa/levodopa (ND0612, SC) infusion vs immediate-release carbidopa/levodopa (CD/LD, PO) in 300 patients with PD experiencing motor fluctuations, evaluating its safety, efficacy and tolerability
- Mitsubishi’s subsidiary NeuroDerm is leading the P-III study with primary objective to determine the effect of ND0612 on daily “GOOD ON” time as measured by a self-reported patient diary assessing motor function
- ND0612 is a liquid formulation of carbidopa and levodopa administered subcutaneously for PD patients and has also shown safe and well tolerated results in P-I and P-II studies. Additionally, NeuroDerm plans to file its NDA to the UD FDA
Click here to read full press release/ article | Ref: Mitsubishi Tanabe | Image: Bioworld