Our Solution
Redefining the Gold StandardIntegrated Pharma and MedTech:
Tailored solution for people with Parkinson’s disease
NeuroDerm specializes in integrating proprietary pharmaceutical formulations, state-of-the-art delivery system, and digital health solutions with the aim of reducing disease burden and improving the quality of life of patients and their families.
NeuroDerm’s uniqueness lies in integrating diverse capabilities into a comprehensive solution for the benefit of patients and the future of healthcare and healthcare connectivity.
NeuroDerm’s flagship product ND0612 is currently in late stage development for Parkinson’s disease patients experiencing motor fluctuations.
Our system for self-administered continuous subcutaneous infusion of the gold standard levodopa/carbidopa, was designed specifically to be a user-friendly system for people with Parkinson's disease, to maintain steady therapeutic levodopa plasma concentrations for the purpose of improving fluctuations, that is, reducing patients’ "OFF" time without increasing troublesome dyskinesia.
Our tailored solution potentially offers sustained relief (compared to oral immediate-release levodopa/carbidopa treatments) and empowers patients and their families to regain control of their lives with greater daily-life predictability and independence.
Clinical trials
ND0612 has successfully completed Phase I and II clinical trials and completed recruiting patients for a Phase III efficacy study. The BeyoND pivotal study was designed to evaluate the long-term safety of ND0612 and has been completed with over 4 years of accumulated long-term safety data.
The BouNDless pivotal study, designed to evaluate the efficacy of ND0612, completed recruitment.
ND0612 clinical trials current status:
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Phase 1
NeuroDerm has completed 8 Phase-I and clinical pharmacology studies, ranging from small dose-finding studies to 12-month population pharmacokinetics studies.
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Phase 2
Three completed Phase-II studies have established a robust platform of evidence supporting the safety, tolerability, and preliminary efficacy of ND0612 in people with Parkinson’s disease.
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Phase 3
BouNDless Study - Still recruiting
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Phase 4
BeyoND Study
BeyoND is an open-label study of ND0612 designed to evaluate the long-term safety and tolerability of ND0612 in patients with Parkinson’s disease experiencing motor fluctuations. With over 100 patients having completed the first 12 months in the BeyoND study, ND0612 was found to be safe with generally mild to moderate infusion site reactions typical of a subcutaneous mode of continuous drug delivery, and no unexpected TEAEs for systemic levodopa treatment. Long-term data will continue to be collected from patients enrolled in the study extension, some of whom are now in their fifth year of ND0612 treatment. More information can be found at ClinicalTrials.gov.
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BouNDless Study
BouNDless is a Phase-III randomized, active-controlled, double-blind, double-dummy trial designed to establish the efficacy, safety, and tolerability of ND0612 in comparison to oral immediate-release LD/CD in patients with Parkinson's disease experiencing motor fluctuations.
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Let's Stay in Touch
For general inquiries or to learn more about NeuroDerm, please complete the form below. For medical information or to report on your own health or experience, please consult your healthcare provider. Please click here for information about our clinical trials.
