NeuroDerm Announces Highly Positive Results from the Pivotal Phase III BouNDless Trial Evaluating ND0612 in Parkinson's Disease Patients with Motor Fluctuations ■About Parkinson's Disease Parkinson's disease affects more than ten million patients worldwide.1 It is caused by decreasing dopamine signaling in the brain as dopaminergic brain cells die off.2 The major motor symptoms include akinesia (or bradykinesia) with reduced movement, the three major symptoms of tremor (tremor of the hands and feet) and (muscle) rigidity (stiffness), as well as postural retention disorders.3 It is also known that Parkinson's disease is associated with non-motor symptoms such as sleep disorder, mental/cognitive/behavioral disorder, autonomic nerve disorder, and sensory disorder.3 Although there is no fundamental treatment method, levodopa, which shows antiparkinsonian effect by compensating for decreased dopamine, is used as a therapeutic drug.3 Levodopa is the most important replacement therapy for Parkinson's disease, administered together with a levodopa degradation inhibitor (usually carbidopa). Oral levodopa intake leads to fluctuating plasma concentrations, with high peaks and low troughs that contribute to the progressive emergence of disabling clinical oscillations over the day in the motor function of many people with Parkinson's disease.5 ■About ND0612 ND0612 is the first liquid formulations of levodopa and carbidopa to be administered subcutaneously to conveniently achieve steady state levodopa plasma levels. There is an ongoing unmet need for treatment innovation for people with Parkinson's disease, as oral levodopa/carbidopa treatments yield a variable and unfavorable pharmacokinetic profile to maintain a stable clinical response. ND0612 is a drug-device combination therapy - a 24 hours/day, continuous subcutaneous infusion of liquid levodopa/carbidopa designed to reduce motor fluctuations in patients with Parkinson's disease and avoid invasive treatment by improving the drugs' pharmacokinetic and maintain stable and continuous therapeutic levodopa plasma concentrations.
■About NeuroDerm, Ltd.
NeuroDerm is a wholly owned subsidiary of MTPC, based in Israel, inspired to reduce disease burden and improve the quality of life of patients and their families through innovative drug-device combination therapies and technologies. Mitsubishi Tanabe Pharma wholly owned NeuroDerm in October 2017 to expand its pipeline in the key R&D disease area, central nervous system. For additional information, please visit NeuroDerm's website at www.neuroderm.com
References
- Who Has Parkinson's? Parkinson's Foundation. Available at:
- Parkinson's 101. The Michael J. Fox Foundation. Available at:
- Parkinson's Disease Guidelines 2018 (Japanese only). Available at:
- 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.
- C D Marsden. Problems with long-term levodopa therapy for Parkinson's disease. Clin Neuropharmacol. 1994;17 Suppl 2: S32-44.
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Mitsubishi Chemical Group Corporation published this content on 10 January 2023 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 10 January 2023 02:16:04 UTC.