ND0612
Publisher: Datamonitor Healthcare
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Drug Overview
The ND0612 (Mitsubishi Tanabe) product line comprises two subcutaneous, continuously delivered carbidopa/levodopa liquid formulations: the lower-dose ND0612L, and the higher-dose ND0612H. ND0612L is being investigated for the treatment of moderate Parkinson’s disease, and is intended to be administered through a belt pump or patch pump. ND0612H, under development for advanced Parkinson’s disease, is delivered via a belt pump. ND0612’s continuous administration allows for steady levodopa levels over 24 hours, avoiding the fluctuations in concentration that result in peak-dose dyskinesia, and in “off” periods.
NeuroDerm had previously guided that it anticipates filing ND0612 for regulatory approval in the US via the 505(b)(2) pathway during H2 2018, and will also file for approval in the EU. The company has since been acquired by Mitsubishi Tanabe, which lists ND0612 as a Phase II development project in its pipeline, suggesting that further pivotal clinical trials are likely.
CONTENTS
4 OVERVIEW
4 Drug Overview
5 Product Profiles
5 ND0612 : Parkinson’s disease
LIST OF FIGURES
8 Figure 1: ND0612 for Parkinson’s disease – SWOT analysis
9 Figure 2: Datamonitor Healthcare’s drug assessment summary of ND0612 for Parkinson’s disease
10 Figure 3: Datamonitor Healthcare’s drug assessment summary of ND0612 for Parkinson’s disease
12 Figure 4: ND0612 sales for Parkinson’s disease across the US and five major EU markets, by country, 2016–25
LIST OF TABLES
6 Table 1: ND0612 drug profile
7 Table 2: ND0612 late-phase trials in Parkinson’s disease
13 Table 3: ND0612 sales for Parkinson’s disease across the US and five major EU markets, by country ($m), 2016–25
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