Infudopa SubC (levodopa/carbidopa SC) / Dizlin, Neuraxpharm - LARVOL DELTA

Neuraxpharm and Dizlin Pharmaceuticals Announce Global Strategic Co-Development Agreement Bringing Next-Generation Drug-Device Therapy to Patients with Advanced Parkinson's Disease (PRNewswire) - "Neuraxpharm Group...and Dizlin Pharmaceuticals AB...announced a strategic global co-development agreement for Infudopa SubC — a next-generation, wearable drug-device therapy that offers a user-friendly, flexible, and physiologically sound alternative to existing advanced Parkinson's treatments, hence empowering patients with greater independence...This agreement marks a pivotal milestone for Neuraxpharm as it enters the drug-device space with its first-ever combination therapy, reinforcing its commitment to pioneering innovation in CNS and addressing some of the most pressing unmet needs in neurological care."

Licensing / partnership • Parkinson's Disease

Efficacy of Continuous Subcutaneous Levodopa/Carbidopa Infusion (ND0612) on Motor Signs of PD and Experiences of Daily Living (PRNewswire) - P3 | N=381 | BouNDless (NCT04006210) | Sponsor: NeuroDerm Ltd. | "During the BouNDless trial, at both eight and 12 weeks, treatment with ND0612 showed superior improvements in m-EDL vs. oral IR-LD/CD, as measured by the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II and Part III scores. Additionally, a post-hoc analysis of treatment differences for a number of motor signs showed treatment with ND0612 was superior to oral IR-LD/CD, with improvements observed in postural instability-gait disorder (–0.26 vs. 0.02, p=0.0012), speech and oral health (–0.11 vs. 0.05, p=0.0140), tremor (–0.15 vs. –0.05, p=0.0992) and self-care (–0.08 vs. 0.09, p=0.0528). No relevant differences were observed for rigidity and bradykinesia."

P3 data • CNS Disorders • Parkinson's Disease

Quality of Life with 24-hour Subcutaneous Levodopa/Carbidopa Infusion (ND0612): PDQ-39 Results from a Phase 3 Randomized, Active-Controlled Study (PRNewswire) - P3 | N=381 | BouNDless (NCT04006210) | Sponsor: NeuroDerm Ltd. | "At the end of 12 weeks, patients in the continuous 24-hour ND0612 treatment group reported improved QoL (-2.1 [-3.7, -0.6]) compared to no change in the IR-LD/CD group (+0.6 [-0.9, 2.1]). The PDQ-39 domain analyses favored ND0612 treatment in most domains; mean changes were mobility, bodily discomfort, cognition, activities of daily living, stigma, social support, communication and emotional well-being."

P3 data • CNS Disorders • Parkinson's Disease

Long-Term Efficacy of 24-hour Subcutaneous Levodopa/Carbidopa Infusion (ND0612) for Motor Fluctuations in Parkinson's Disease (PRNewswire) - P3 | N=381 | BouNDless (NCT04006210) | Sponsor: NeuroDerm Ltd. | "At six months, patients treated with ND0612 experienced an average reduction of 2.2 hours in daily OFF time and an increase of 2.4 hours in daily ON time without troublesome dyskinesia. These results were sustained at 12 months, showing an average reduction of 2.02 hours in OFF time and an increase of 2.11 hours in ON time without troublesome dyskinesia. In addition, patients with one or more hours of ON time with troublesome dyskinesia at ND0612 initiation (n=45) experienced an average reduction of troublesome dyskinesia by 1.5 hours at 12 months, further demonstrating sustained efficacy."

P3 data • CNS Disorders • Parkinson's Disease

Motor Efficacy of Subcutaneous DIZ102, Intravenous DIZ101 or Intestinal Levodopa/Carbidopa Infusion. (PubMed, Mov Disord Clin Pract) - "Although DIZ101 or DIZ102 causes approximately four times higher plasma carbidopa levels than LCIG, patients responded equally well to all treatments. The results do not indicate that high plasma carbidopa levels hamper the motor efficacy of levodopa."

Journal • CNS Disorders • Movement Disorders • Parkinson's Disease

Subcutaneous Levodopa: A New Engine for the Vintage Molecule. (PubMed, Neurol Ther) - "The key focus of this review is placed on subcutaneous foslevodopa/foscarbidopa (Foslevodopa/foscarbidopa) infusion, showcasing its recent clinical availability and efficacy in providing continuous levodopa delivery. While providing an overview of the other non-oral levodopa-based CDD systems, such as intrajejunal levodopa-carbidopa infusion and levodopa-entacapone-carbidopa infusion, we highlight the current promising evidence for Foslevodopa/foscarbidopa to improve, for example, "on time" without troublesome dyskinesia and reducing "off time" in people with advanced PD...While these advancements present new therapeutic avenues, long-term observational studies are warranted to elucidate their impact on existing PD therapies. Overall, this review provides insights into the evolving landscape of non-oral CDD therapies and offers a pragmatic approach for their integration into clinical practice."

Journal • Review • CNS Disorders • Movement Disorders • Parkinson's Disease

Motor function in Parkinson´s disease during 16h treatment with intravenously (DIZ101), subcutaneously (DIZ102), or intestinally (LCIG) infused levodopa (MDS Congress 2023) - "There was no observable trend for lower levodopa efficacy on motor symptoms, despite the higher CD concentrations with DIZ101 and DIZ102 compared to LCIG [1]. This indicates, in line with previous reports [2][3], that high blood levels (up to approximately 800 ng/mL) of carbidopa do not reduce the CNS effect of levodopa."

CNS Disorders • Parkinson's Disease

Continuous subcutaneous levodopa-carbidopa for the treatment of advanced Parkinson's disease: is it an improvement on other delivery? (PubMed, Expert Opin Drug Deliv) - "Parkinson's disease (PD) is the second most common neurodegenerative disease and is growing in prevalence and disability. Both ND0612 and ABBV-951 only cause modest reductions in OFF time. It is not clear whether these subcutaneous preparations will have more benefits than the intestinal gel, which also reduces OFF time and dyskinesia."

Journal • Metastases • Review • CNS Disorders • Gastrointestinal Disorder • Movement Disorders • Parkinson's Disease

Dizlin Pharmaceuticals publishes data from pharmacokinetic study (PK) (IPO-001) with Infudopa SubC (DIZ102) and Infudopa IntraV (DIZ101) in Neurology (PRNewswire) - P1 | N=25 | NCT03419806 | Sponsor: Vastra Gotaland Region |"Dizlin Pharmaceuticals AB...announces that an article has been published in Neurology®, from the American Academy of Neurology...In a pharmacokinetic cross-over study comprising 18 evaluable subjects with advanced Parkinson´s disease, levodopa/carbidopa solutions with a pH of 5.5 were produced by continuous buffering shortly prior to intravenous (DIZ101) or subcutaneous (DIZ102) administration....'The outcome shows that subcutaneous administration of a continuously buffered levodopa solution could be a feasible technique to safely and rapidly obtain high and stable levodopa levels in patients with Parkinson´s disease'....'The results suggest that DIZ102 (Infudopa SubC™), administered by means of a portable twin pump, may serve as a levodopa/carbidopa monotherapy for patients requiring high levodopa levels but experience motor fluctuations when receiving oral administration.'"

P1 data • PK/PD data • CNS Disorders • Parkinson's Disease

[VIRTUAL] SUBCUTANEOUS INFUDOPA (LEVODOPA/CARBIDOPA) INFUSION COULD BE SUITABLE MONOTHERAPY IN PATIENTS WITH ADVANCED PARKINSON’S DISEASE (ADPD 2021) - "Bioequivalence to Duodopa treatment was shown for subcutaneous and intravenous administration, with equal early and steady-state levodopa plasma concentrations. Slower elimination of levodopa after subcutaneous infusion may give better night time sleep for the patients reducing complementary oral medication. Subcutaneous Infudopa infusion is a well-tolerated and clinically efficient treatment that is feasible as monotherapy also for patients requiring high doses, easy to perform, and requries no surgical intervention."

Clinical • Monotherapy • CNS Disorders • Movement Disorders • Pain • Parkinson's Disease