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NeuroDerm Announces Highly Positive Results from the Pivotal Phase III BouNDless Trial Evaluating ND0612 in Parkinson's Disease Patients with Motor Fluctuations

ND0612, a continuous 24 hours/day subcutaneous (SC) infusion?of liquid levodopa/carbidopa (LD/CD), showed superior efficacy compared to oral LD/CD for the primary endpoint ("ON" time without troublesome dyskinesia, also called "Good ON" time) and the key secondary endpoint ("OFF" time).1 ND0612 also demonstrated superior efficacy on several pre-defined secondary endpoints, including the MDS-Unified Parkinson's Disease Rating Scale Part II score (MDS-UPDRS motor experiences of daily living sub-score), Patient Global Impression of Change (PGIC) and Clinical Global Impression of Improvement (CGI-I).1 ND0612 systemic adverse events were typical to the well-established safety profile of oral LD/CD. 1,3 Infusion site reactions associated with ND0612 treatment were mostly non-serious and mild to moderate in severity.1 ND0612 was well tolerated, with only 6.3% of patients randomized to ND0612 discontinuing the trial, including 5.5% who discontinued due to adverse events.1 or follow us on LinkedIn. 

About Mitsubishi Tanabe Pharma Corporation and Mitsubishi Chemical Group 

Mitsubishi Tanabe Pharma Corporation (MTPC), the pharma arm of Mitsubishi Chemical Group (MCG), is one of the oldest pharmaceutical companies in the world, founded in 1678, and focusing on ethical pharmaceuticals. MTPC is headquartered in Doshomachi, Osaka, the birthplace of Japan's pharmaceutical industry. MCG has positioned health care as its strategic focus in its management policy, "Forging the future." With the MISSION of "creating hope for all facing illness," MTPC is prioritizing work on "precision medicine" to provide drugs with high treatment satisfaction by identifying patient populations with high potential for efficacy and safety, focusing on the disease areas of central nervous system and immuno-inflammation. For more information, go to https://www.mt-pharma.co.jp/e/. 

About Mitsubishi Tanabe Pharma GmbH 

Mitsubishi Tanabe Pharma GmbH, based in Düsseldorf, was founded in 2003 under the name Mitsubishi Pharma Deutschland GmbH as a subsidiary of Mitsubishi Pharma Europe Ltd. (London/UK) which is an affiliate of Mitsubishi Tanabe Pharma Cooperation in Japan. Germany was the first country representative to market products from its own research outside Asia.  

References  

Data on File. S Fahn. Levodopa in the treatment of Parkinson's disease. J Neural Transm Suppl.2006;(71):1-15. doi: 10.1007/978-3-211-33328-0_1.Dijk JM et al, The Choice Between Advanced Therapies for Parkinson's Disease Patients: Why, What, and When? J Parkinsons Dis 2020;10(s1):S65-S73.?Efficacy, Safety and Tolerability Study of ND0612 vs. Oral IR-LD/CD in Subjects with PD Experiencing Motor Fluctuations (BouNDless). Available at: https://clinicaltrials.gov/ct2/show/NCT04006210. Accessed November 7, 2022.S Isaacson, C Warren Olanow, T Simuni, et al. Long-term safety of continuous levodopa/carbidopa infusion with ND0612: Results from the ongoing BeyoND study. Poster presented at: American Academy of Neurology Annual Meeting; 2022 Apr 2-7; Seattle, WA.Who Has Parkinson's? Parkinson's Foundation. Available at: https://www.parkinson.org/Understanding-Parkinsons/Statistics#:~:text=More%20than%2010%20million%20people. Accessed November 10, 2022.Parkinson's 101. The Michael J. Fox Foundation. Available at: https://www.michaeljfox.org/parkinsons-101#q2. Accessed March 15, 2022. Poewe W, Seppi K, Tanner CM, Halliday GM, Brundin P, Volkmann J, Schrag AE, Lang AE.
Parkinson disease. Nat Rev Dis Primers. 2017 Mar 23;3:17013.Fox SH, Katzenschlager R, Lim SY, Barton B, de Bie RMA, Seppi K, Coelho M, Sampaio C; Movement Disorder Society Evidence-Based Medicine Committee.International Parkinson and movement disorder society evidence-based medicine review: Update on treatments for the motor symptoms of Parkinson's disease. Mov Disord. 2018 Aug;33(8):1248-1266.C Warren Olanow, J Obeso, F Stocchi. Drug Insight: continuous dopaminergic stimulation in the treatment of Parkinson's disease.?Nat Rev Neurol?2, 382–392 (2006).  

 

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