levodopa/carbidopa low dose (ND0612L) / Mitsubishi Tanabe - LARVOL DELTA

Mitsubishi Tanabe Pharma America to Present New Data on Investigational ND0612 at the 2025 International Congress of Parkinson's Disease and Movement Disorders (PRNewswire) - "Presentations will share findings from the pivotal Phase 3 BouNDless study (NCT04006210), which evaluated ND0612 vs. standard of care in people with PD experiencing motor fluctuations."

Clinical data • Parkinson's Disease

Mitsubishi Tanabe Pharma America Highlights Parkinson's Disease Research at 2025 EAN and ATMRD Congresses (PRNewswire) - "MTPA will be presenting one e-poster describing the effect of treatment with ND0612 on OFF and ON episodes, their duration, and transitions, in people experiencing motor fluctuations, as observed from the pivotal Phase 3 BouNDless study (NCT04006210) and its one-year open-label extension (OLE) phase."

P3 data • Parkinson's Disease

Mitsubishi Tanabe Pharma America Announces U.S. FDA Acceptance of New Drug Application Resubmission for Investigational ND0612 for the Treatment of Motor Fluctuations in Parkinson's Disease (PRNewswire) - "Mitsubishi Tanabe Pharma America...announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) resubmission for investigational ND0612, a 24-hours/day, continuous, subcutaneous (SC) infusion of liquid levodopa/carbidopa (LD/CD), for the treatment of motor fluctuations in people living with Parkinson's disease (PD). The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date in the fourth quarter of 2025....The NDA is supported by data from the pivotal, Phase 3, multi-center, randomized, double-blind double-dummy (DBDD) BouNDless trial (NCT04006210), which evaluated the effectiveness and safety of ND0612 in people with PD experiencing motor fluctuations, as well as long-term safety data from the ongoing Phase 2b BeyoND study (NCT02726386) of ND0612, with some study participants in their eighth year of follow-up."

FDA filing • PDUFA • Parkinson's Disease

European Medicines Agency (EMA) accepts marketing authorization application for Parkinson's disease drug candidate ND0612 [Google translation] (Mitsubishi Tanabe Press Release) - "Mitsubishi Tanabe Pharma...received notice on February 20th (local time) that the European Medicines Agency (EMA) had accepted its marketing authorization application for ND0612, a candidate drug under development for the treatment of Parkinson's disease with diurnal motor fluctuations. ND0612 was developed by NeuroDerm Ltd. (Head Office: Rehovot, Israel; CEO: Kengo Isshiki), a wholly owned subsidiary of Mitsubishi Tanabe Pharma, and the application was submitted by Mitsubishi Tanabe Pharma GmbH (Head Office: Dusseldorf, Germany) under the EMA's centralized review procedure, which applies to all member states of the European Union (EU) as well as Iceland, Norway and Liechtenstein....This application was based primarily on efficacy, safety and tolerability evaluation data from a global Phase 3 clinical trial (BouNDless study)."

EMA approval • Parkinson's Disease

Investigational ND0612 (PRNewswire) - "Presentations include findings from subgroup analyses from the pivotal Phase 3 BouNDless trial (NCT04006210) evaluating the efficacy and safety of investigational ND0612 across a range of sociodemographic groups of people with PD experiencing motor fluctuations, as well as findings from an integrated analysis characterizing infusion site reactions reported in patients treated with ND0612."

P3 data • CNS Disorders • Parkinson's Disease

Descriptive case studies of patients in their fifth consecutive year of treatment with ND0612 (ATMRD 2024) - No abstract available.

Continuous subcutaneous levodopa/carbidopa infusion with ND0612 for patients with Parkinson’s disease and motor fluctuations: Results from the Phase 3 randomized, active-controlled BouNDless study (ATMRD 2024) - No abstract available.

P3 data

Reductions in OFF time with ND0612 for patients with Parkinson’s disease experiencing motor fluctuations: Responder-analysis from an open-label Phase 2 study (ATMRD 2024) - No abstract available.

P2 data

Investigational Pump Agents to Treat Parkinson Disease (NeurologyLive) - "In this segment, Kremens described pump therapies currently in development, such as ND0612 and ABBV-951."

Video

Mitsubishi Tanabe Pharma America to Showcase Breadth of Neurodegenerative Research at 2024 American Academy of Neurology Annual Meeting (PRNewswire) - "Presentations include new data from a subgroup analysis from the pivotal Phase 3 BouNDless trial (NCT04006210) evaluating the efficacy and safety of investigational ND0612 in different subgroups of people with PD experiencing motor fluctuations, in addition to findings characterizing infusion site reactions (ISR) reported from treatment with ND0612 in clinical studies....Additional presentations include a post-hoc analysis from the 28-day open-label Study 006 evaluating ND0612 efficacy onset data and findings from a responder analysis of the ongoing Phase 2b BeyoND long-term safety study (NCT02726386) assessing efficacy data for ND0612 in reducing OFF time in people with PD with motor fluctuations."

P2b data • P3 data • Retrospective data • CNS Disorders • Parkinson's Disease

Investigational Parkinson Treatment ND0612 Demonstrates Efficacy, Safety in Published Phase 3 BouNDless Trial (NeurologyLive) - "'Orally administered levodopa/carbidopa tablets remain the most essential pharmacological intervention in Parkinson disease; however, over time, the reliability of its benefits can decrease, leading to the onset of motor fluctuations,' Espay said in a statement."

Media quote

Mitsubishi Tanabe Pharma America Announces Presentations in Parkinson's Disease at 2024 International Conference on Alzheimer's and Parkinson's Diseases (AD/PD) (PRNewswire) - "Mitsubishi Tanabe Pharma America, Inc...today announced two posters in Parkinson's disease (PD) will be shared at the International Conference on Alzheimer's and Parkinson's Diseases (AD/PD 2024), being held in Lisbon, Portugal, and virtually, from March 5-9....Presentations include findings of a responder-analysis from the Phase 2b BeyoND (NCT02726386) long-term safety study assessing efficacy data for investigational ND0612 in reducing OFF time in people with PD with motor fluctuations. Additionally, a second presentation will highlight progress in the development of a Motor Fluctuations Patient Journey Map for people with PD to describe the holistic patient experience from pre-diagnosis through long-term treatment."

P2b data • CNS Disorders • Parkinson's Disease

Carbidopa Levodopa Enteral Suspension Leads to Greater Cost-Effectiveness Over Standard Care (NeurologyLive) - "Led by Rajesh Pahwa, MD...a previously published Markov model was adapted to the US healthcare setting with patient level data from an open-label clinical trial (NCT00335153) and an observational study (GLORIA). The model, comprised of 25 health states and a death state, represented the first cost-effectiveness model assessing CLES compared with SoC from a US payer perspective."

Media quote

Mitsubishi Tanabe Pharma America Presents Positive Results from Pivotal Phase 3 BouNDless Trial of Investigational ND0612 in People with Parkinson's Disease Experiencing Motor Fluctuations (PRNewswire) - P3 | N=381 | BouNDless (NCT04006210) | Sponsor: NeuroDerm Ltd. | "Mitsubishi Tanabe Pharma America, Inc...announced the presentation of positive results from the pivotal, Phase 3, multi-center, randomized, double-blind double-dummy (DBDD) BouNDless trial of investigational ND0612 – a continuous, 24 hours/day subcutaneous (SC) infusion of liquid levodopa/carbidopa (LD/CD) – as part of the International Congress of Parkinson's Disease and Movement Disorder Society (MDS), being held in Copenhagen, Denmark, August 27-31. The study, which evaluated the efficacy, safety and tolerability of ND0612 in comparison to oral immediate-release (IR) LD/CD in people with Parkinson's disease (PD) experiencing motor fluctuations, met its primary endpoint and the first four secondary endpoints. Results, which follow positive topline data reported earlier this year, will be presented as both a poster and part of an Oral Platform Presentation at the meeting."

P3 data • CNS Disorders • Parkinson's Disease

Mitsubishi Tanabe Pharma America Announces Presentations in Parkinson's Disease at 2023 International Congress of Parkinson's Disease and Movement Disorders Society (MDS) (PRNewswire) - "Mitsubishi Tanabe Pharma America, Inc...today announced that four presentations in Parkinson's disease (PD) will be shared at the International Congress of Parkinson's Disease and Movement Disorder Society (MDS), being held in Copenhagen, Denmark, August 27-31....Presentations include results from the ongoing pivotal Phase 3 multi-center, randomized, double-blind double-dummy (DBDD) BouNDless study...in addition to findings of a responder-analysis from the Phase 2b BeyoND long-term safety study assessing the efficacy of ND0612 in reducing OFF time in people with PD with motor fluctuations. Results from the BouNDless study, which follow positive topline data reported earlier this year, will be presented as both a poster and part of an Oral Platform Presentation at the meeting. Additional presentations will highlight three-year safety and efficacy outcomes from the BeyoND long-term safety study..."

P2b data • P3 data • CNS Disorders • Parkinson's Disease

Efficacy of 24-hour subcutaneous levodopa/carbidopa infusion with ND0612 for patients with Parkinson’s disease experiencing motor fluctuations: Subgroup-analysis from the open-label BeyoND study (WPC 2023) - P2b | N=214 | BeyoND (NCT02726386) | Sponsor: NeuroDerm Ltd. | "Findings support improved Good On time for all patient subgroups treated with 24-hour subcutaneous levodopa/carbidopa infusion with ND0612."

P2b data

Enrollment characteristics for patients entering a Phase 3 study of subcutaneous levodopa/carbidopa infusion with ND0612 (WPC 2023) - P3 | N=259 | BouNDless (NCT04006210) | Sponsor: NeuroDerm Ltd. | "Enrollment characteristics of patients randomized in the BouNDless trial are consistent with those observed in other clinical studies in PwP experiencing motor fluctuations."

P3 data

Mitsubishi Tanabe Pharma America Highlights Latest Research in Parkinson's Disease at EAN and WPC 2023 Congresses (PRNewswire) - "Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced the presentation of seven abstracts in Parkinson's disease (PD) at the 9th Congress of the European Academy of Neurology (EAN), which was held in Budapest, July 1-3, and the 6th World Parkinson Congress (WPC), being held in Barcelona, July 4-7....Presentations highlighted findings from two ongoing studies of investigational ND0612 in people with PD with motor fluctuations, including topline results from the Phase 3 multi-center, randomized, double-blind double-dummy (DBDD) BouNDless trial evaluating the efficacy, safety and tolerability of ND0612, in addition to three-year outcomes from the Phase 2b open-label BeyoND study evaluating the long-term safety of ND0612. Additionally, results were shared from an open-label pharmacokinetic study assessing the relative bioavailability of levodopa when administered with ND0612 vs. oral levodopa/carbidopa (LD/CD)."

P2 data • P2b data • P3 data: top line • CNS Disorders • Parkinson's Disease

Descriptive case studies of patients in their fifth consecutive year of treatment with ND0612 (WPC 2023) - "Continuing into their fifth year of treatment, these patients exemplify the favorable long-term benefit/risk profile of ND0612 and will serve to inform future patient selection and education."

Onset of efficacy with continuous, subcutaneous levodopa/carbidopa infusion in patients with PD experiencing motor fluctuations (WPC 2023) - "Results of this analysis demonstrate that patients experience statistically significant and clinically relevant improvements with 24-hour subcutaneous infusion with ND0612 at Day 3 after treatment initiation that improved further to Day 28 (primary endpoint)."

Clinical

Mitsubishi Tanabe Pharma America to Present Latest Findings Across ALS and Parkinson’s Disease at 2023 American Academy of Neurology Annual Meeting (PRNewswire) - "Presentations include topline results from the ongoing Phase 3 multi-center, randomized, double-blind double-dummy (DBDD) BouNDless trial evaluating the efficacy, safety and tolerability of investigational ND0612 in people with PD experiencing motor fluctuations, in addition to three-year outcomes from the ongoing Phase 2b open-label BeyoND study evaluating the long-term safety of ND0612 in people with PD with motor fluctuations. Findings from the BouNDless and BeyoND studies will be presented orally as part of an Emerging Science Platform Session and Plenary Session, respectively. Additionally, results from an open-label pharmacokinetic study assessing the relative bioavailability of levodopa when administered with ND0612 vs. oral levodopa/carbidopa (LC/CD) will be shared...Mitsubishi Tanabe Pharma America to Present Latest Findings Across ALS and Parkinson's Disease at 2023 American Academy of Neurology Annual Meeting."

P2b data • P3 data • CNS Disorders • Parkinson's Disease

Changes in Continuous Subcutaneous Liquid levodopa/carbidopa Administration (ND0612) for patients with fluctuating Parkinson’s disease Development Plan and an Impairment Loss (Non-recurring Items) (Mitsubishi Tanabe Press Release) - "Mitsubishi Tanabe Pharma Corporation...announced today that its subsidiary, NeuroDerm Ltd...has changed the global phase 3 clinical trial plan of continuous subcutaneous liquid levodopa/carbidopa administration (ND0612) in the U.S. and Europe. Following this change, MTPC recorded an impairment loss for a part of intangible assets in the first-half of FY2020. In the global development of ND0612, due to the overlap between the expansion of COVID-19 and the important start-up period of phase 3 study; opening clinical trial sites and patient enrollment, MTPC decided to extend the development period for about 1.5 years from the plan at the time of review of 'Medium-Term Management Plan 16 -20' announced in November 2018. Under the revised ND0612 development plan, NDA/MAA are to be filed in the U.S. and Europe simultaneously in FY2023."

Enrollment status • European regulatory • NDA • Trial status • CNS Disorders • Parkinson's Disease

BeyoND Phase 2b Data Indicates ND0612 Has a Positive Long-Term Safety Profile for People with Parkinson's Disease (PRNewswire) - P2 | N=210 | BeyoND (NCT02726386) | Sponsor: NeuroDerm Ltd. "NeuroDerm Ltd...announced positive, long-term safety and tolerability data for ND0612 at the American Academy of Neurology Annual Meeting (in Seattle, April 2-7, and virtually, April 24-27)....Cumulative safety data from the ongoing BeyoND study for ND0612 was evaluated for the 114 participants enrolled in the long-term extension period of the study (beyond one year), with some participants having entered their sixth year of treatment. The analysis demonstrates that ND0612 treatment remains safe and well tolerated over the long term in people with Parkinson's disease experiencing motor fluctuations."

P2b data • CNS Disorders • Parkinson's Disease

ND0612 (levodopa/carbidopa for subcutaneous infusion) in patients with Parkinson’s disease and motor response fluctuations: A randomized, placebo-controlled phase 2 study. (PubMed, Parkinsonism Relat Disord) - "Levodopa/carbidopa infusion with ND0612 was generally well-tolerated and resulted in reduced fluctuations in plasma levodopa concentrations when given with SoC oral levodopa. ND0612 met the efficacy endpoint for the futility design."

Clinical • Journal • P2 data • CNS Disorders • Movement Disorders • Parkinson's Disease

[VIRTUAL] Developing a drug-device combination for patients with Parkinson’s disease during the COVID19 pandemic (EAN 2021) - "Background and aims: ND0612 is a continuous, subcutaneous levodopa/carbidopa delivery system in development for people with Parkinson’s disease (PwP)... The changes implemented were well-accepted by the investigators and patients and ensured patient safety while maintaining the clinical trial integrity. We found that clear and frequent communication, with a balanced ‘hybrid’ mix of virtual and in-person approaches, successfully enabled the safe continuation of pivotal clinical trials with this drug-device combination in patients with PD."

Clinical • CNS Disorders • Infectious Disease • Movement Disorders • Novel Coronavirus Disease • Parkinson's Disease