entacapone/levodopa/carbidopa / Generic mfg. - LARVOL DELTA

Alembic Pharmaceuticals Ltd on Friday said it has received approval from the US health regulator for its generic version of Carbidopa, Levodopa and Entacapone tablets used in treatment of Parkinson's disease. (Business Standard) - "The approval by the US Food & Drug Administration (USFDA) is for the Abbreviated New Drug Application (ANDA) of Carbidopa, Levodopa and Entacapone tablets of strengths 12.5 mg/50 mg/200 mg; 18.75 mg/75 mg/200 mg; 25 mg/100 mg/200 mg; 31.25 mg/125 mg/200 mg; 37.5 mg/150 mg/200 mg; and 50 mg/200 mg/200 mg, Alembic Pharmaceuticals Ltd said in a regulatory filing."

ANDA • Parkinson's Disease

SWITCH-ON: Long Term Effectiveness of Levodopa-Entacapone-Carbidopa Intestinal Gel in Participants With Advanced Parkinson's Disease (clinicaltrials.gov) - P=N/A | N=215 | Recruiting | Sponsor: Britannia Pharmaceuticals Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Movement Disorders • Parkinson's Disease

SWITCH-ON: Long Term Effectiveness of Levodopa-Entacapone-Carbidopa Intestinal Gel in Participants With Advanced Parkinson's Disease (clinicaltrials.gov) - P=N/A | N=215 | Not yet recruiting | Sponsor: Britannia Pharmaceuticals Ltd.

New trial • CNS Disorders • Movement Disorders • Parkinson's Disease

Levodopa/carbidopa/entacapone versus levodopa/benserazide plus pramipexole in Chinese patients with Parkinson's disease experiencing wearing off. (PubMed, Front Neurol) - "One patient in the LCE group and 2 patients in the PPX group experienced mild dyskinesia. LCE and LB + PPX were both effective, safe and tolerable in treating patients with PD who experienced WO."

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

Voltammetric analysis of entacapone, levodopa, and carbidopa in tablets: A chemometric approach. (PubMed, J Pharm Biomed Anal) - "The objective of the present work is to develop a voltammetric method for the determination of entacapone (ENT) in the presence of levodopa (LEV) and carbidopa (CAR) in synthetic mixtures and pharmaceutical formulations, using a multivariate approach. To evaluate the validity of the recommended method, a commercial pharmaceutical tablet (Stalevo ® 200 mg) was analyzed. RBF model has the ability to overcome difficulties such as non-linearity and overlaps in the voltammograms."

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

Drug Exposure and Microscopic Colitis: Analysis of a Large Multi-Institutional Research Network (ACG 2025) - "Among Parkinson's disease drugs, the combination agent Stalevo was noted to be associated with significant increase in risk...SSRIs, particularly sertraline, and certain NSAIDs (diclofenac, celecoxib) were associated with highest increase in risk... A total of 1,234,310 patients undergoing colonoscopy with biopsy were analyzed across the cohorts. Among major drug classes, SSRIs [RR 1.40(1.31-1.51)] and NSAIDs [RR 1.05 (1.01-1.11)] were noted to be significantly associated with increased risk of MC diagnosis. Highest risk among SSRIs was noted with Sertraline [RR 1.58 (1.39-1.79)] while Diclofenac was noted to have the highest risk among NSAIDs [RR 1.61 (1.41-1.84)]."

Clinical • Addiction (Opioid and Alcohol) • CNS Disorders • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Movement Disorders • Parkinson's Disease

Infusion therapies for Parkinson's disease: where are we in 2025? (PubMed, Expert Opin Drug Deliv) - No abstract available

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

Treatment Of Advanced Parkinson's With Levodopa–Entacapone–Carbidopa Intestinal Gel – Impact On Dyskinesia (MDS Congress 2025) - P | "Data from ELEGANCE suggest that long-term treatment with LECIG can improve the daily duration of dyskinesia. In the small number of patients who switched from LCIG to LECIG, there was a trend for a slight reduction in daily hours of dyskinesia. Figure 1 Figure 2"

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

Sustained Motor Symptom Efficacy With Long-Term Levodopa–Entacapone–Carbidopa Intestinal Gel (LECIG) Treatment – Data From The ELEGANCE Interim Analysis (MDS Congress 2025) - P | "LECIG showed sustained clinical efficacy in reducing PD motor symptoms, both during the day and at night, following treatment for up to two years. Figure 1 Figure 2 Figure 3"

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

Timing And Type Of Adverse Events Following Long-Term Treatment With Levodopa–Entacapone–Carbidopa Intestinal Gel (LECIG) Infusion – Data From The ELEGANCE Interim Analysis (MDS Congress 2025) - P | "These data suggest that LECIG treatment for up to one year is generally well tolerated by patients with advanced PD. As has been observed with levodopa–carbidopa intestinal gel infusion, the most frequent AEs are associated with the procedure or the device. Table 1"

Adverse events • CNS Disorders • Movement Disorders • Parkinson's Disease

Three-Year Single-Center Experience with Levodopa–Entacapone–Carbidopa Intestinal Gel in Advanced Parkinson's Disease (MDS Congress 2025) - "The therapeutic efficacy of LECIG in mitigating motor complications is comparable to that of levodopa–carbidopa intestinal gel (LCIG), with the added benefits of a reduced daily levodopa requirement and a more compact administration device. However, further longitudinal studies and extended clinical experience are required to determine the relative advantages of these two enteral levodopa formulations within the framework of personalized treatment strategies for advanced Parkinson's disease."

Clinical • Metastases • CNS Disorders • Movement Disorders • Parkinson's Disease

Patient And Clinician Perceptions Of Disease Improvement With Levodopa–Entacapone–Carbidopa Intestinal Gel (LECIG) In Advanced Parkinson's – Data From The ELEGANCE Interim Analysis (MDS Congress 2025) - P | "Both clinicians and PD patients report sustained favourable improvements in their disease following treatment with LECIG for up to two years compared with their baseline condition. Figure 1 Figure 2"

Clinical • Metastases • CNS Disorders • Cognitive Disorders • Movement Disorders • Parkinson's Disease

Split tablet dosing of Levodopa/Carbidopa/Entacapone 100mg/25mg/200mg in treating Chinese patients with early Parkinson's disease: a single-center, prospective cohort study (MDS Congress 2025) - "Split tablet dosing of LCE 100mg/25mg/200mg was effective and safe in treating Chinese patients with early PD. Demographic Data Treatment-emergent adverse events for patients receiving 1/2 LCE tablet tid treatment-naïve patients who received LCE only UPDRS II, III; H&Y PDQ-39; LCE"

Clinical • Back Pain • CNS Disorders • Movement Disorders • Musculoskeletal Pain • Parkinson's Disease

Multidimensional Assessment of Levodopa/Carbidopa/Entacapone Gel (LECIG) Therapy in Parkinson's Disease: Perspectives of Patients, Clinicians, and Caregivers (MDS Congress 2025) - "LECIG therapy significantly reduces caregiver burden and improves patient-reported quality of life in PD. Clinician assessments corroborate these benefits, with no reported worsening. These findings highlight the importance of continuous dopaminergic stimulation in managing advanced PD."

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

Comparative Analysis of miR-29a Expression in Optimized Medical Therapy and Intestinal Infusion Therapies in Advanced Parkinson's Disease (MDS Congress 2025) - "Objective: To compare the relative expression of miR-29a in patients with advanced Parkinson's disease (PD) receiving optimized medical therapy (OMT) versus intestinal infusion therapies—levodopa/carbidopa intestinal gel (LCIG) and levodopa/entacapone/carbidopa intestinal gel (LECIG). In our study, we observed that there was a significant decrease in the relative expression of miR-29a in patients on OMT. This decrease may be associated with greater dopamine level fluctuations, potentially contributing to increased oxidative stress. The stable miR-29a expression in the intestinal infusion groups (LCIG and LECIG) could suggest a neuroprotective effect of continuous levodopa administration, potentially mitigating neuronal stress and inflammation."

Metastases • CNS Disorders • Movement Disorders • Parkinson's Disease • MIR29A

Effects of levodopa-entacapone-carbidopa intrajejunal infusion on non-motor symptoms of advanced Parkinson's disease-interim analysis of the ELEGANCE study. (PubMed, J Neural Transm (Vienna)) - P | "The ELEGANCE study (NCT05043103) is an ongoing, non-interventional registry study collecting real-world data on long-term efficacy, safety and patient-reported outcomes following treatment with levodopa-entacapone-carbidopa intestinal gel (LECIG) infusion. The significant reductions in the scores for two domains, 'sleep/fatigue' and 'gastrointestinal (GI) tract', were sustained at V3. Routine use of LECIG for up to 12 months was found to reduce the overall NMS burden, a factor that is known to impact the quality of life of people with Parkinson's, with particular impact on sleep- and GI-related symptoms."

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

Living Alone Is Associated With Discontinuation of Levodopa-Entacapone-Carbidopa Intestinal Gel Treatment in Advanced Parkinson's Disease. (PubMed, Eur Neurol) - "Yet, no direct comparison to LCIG was made in this study. Similar to LCIG, the discontinuation rate is particularly high among patients living alone."

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

Levodopa-Carbidopa-Entacapone Intestinal Gel for Advanced Parkinson's Disease-Results from a Monocentric Study Evaluating Both Motor and Non-Motor Manifestations. (PubMed, Biomedicines) - "Among the non-motor symptoms, depression and sleep disorders improved, with no changes in cognitive status and psychotic disorders. Adding new data for the use of device-assisted therapy in advanced PD, our study also highlights the need to further research this challenging patient profile."

Journal • CNS Disorders • Depression • Geriatric Disorders • Movement Disorders • Parkinson's Disease • Psychiatry • Sleep Disorder

Intrajejunal levodopa infusion therapy – comparison of real-world data from the ELEGANCE, GLORIA and DUOGLOBE registries (EAN 2025) - P | "Background and aims: The therapeutic options for patients with advanced Parkinson's disease (PD) who choose intrajejunal levodopa infusion treatment are levodopa–carbidopa intestinal gel (LCIG) or levodopa–entacapone–carbidopa intestinal gel (LECIG). At an early stage of treatment with LECIG (up to 12 months) patients in ELEGANCE showed significant improvements in PD motor symptoms, sleep and QoL. These findings are directly comparable to observations after 12 months of treatment with LCIG in the GLORIA and DUOGLOBE studies."

Clinical • Real-world • Real-world evidence • CNS Disorders • Movement Disorders • Parkinson's Disease

COMT inhibition with entacapone for patients with Parkinson's disease and motor complications: the novelty of continuous infusion. (PubMed, J Neural Transm (Vienna)) - "In this review, we describe the pharmacologic rationale for combining COMT inhibition with entacapone and continuous dopaminergic delivery that led to the development of levodopa/entacapone/carbidopa intestinal gel (LECIG). Accumulating real-world evidence with LECIG supports its use in managing motor fluctuations in patients whose control is becoming suboptimal with oral approaches. We provide an overview of the growing evidence base for its risk-benefit profile in patients with motor fluctuations."

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

INITIATE-LECIG: Intestinal Levodopa + Entacapone Therapy (Lecigon®) to Counteract Dopaminergic Desensitization and Neuropsychiatric Complications in Parkinson's Disease (clinicaltrials.gov) - P3 | N=150 | Not yet recruiting | Sponsor: University Hospital Tuebingen

New P3 trial • CNS Disorders • Movement Disorders • Parkinson's Disease • Psychiatry

Cost of Quality of Life in Advanced Parkinson's Disease: Efficient Strategies for Disease Assessment. (PubMed, Rev Neurol) - "These results provide additional information on the efficiency of treatments that should inform decision-making in the management of advanced Parkinson's disease, thus enabling better resource management."

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

Cognitive outcomes of infusion therapies in Parkinson's disease: A comprehensive systematic review. (PubMed, Parkinsonism Relat Disord) - "The cognitive effects of device-aided treatments in PD show substantial variability, and their impact on cognitive function, processing speed, attention, and memory is inconsistent, with some studies reporting impairments and others indicating stability or slight improvements. The heterogeneity in study designs, neuropsychological assessments and coexisting vascular and amyloid pathology further complicates interpretation, underscoring the need for more controlled investigations."

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

Navigating the therapeutic landscape in advanced Parkinson's disease: a comprehensive review from infusion therapies to stem cells. (PubMed, Expert Opin Drug Deliv) - "Emerging infusion therapies (e.g. foslevodopa-foscarbidopa) will boost this tendency. Enhancing DATs accessibility and inclusivity in clinical trials are key priorities. Finally, regenerative therapies including putaminal infusion of neurotrophic factors and dopaminergic neuron precursors may transform advanced PD care."

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

Levodopa Intestinal Gel Infusion Therapies in Advanced Parkinson's Disease: A Swedish Study on Real-World Use and Costs. (PubMed, Neurol Ther) - "Real-world data show that the number of dispensed cassettes and overall treatment costs are higher for LECIG than LCIG treatment among patients with advanced PD in Sweden."

Journal • Real-world evidence • CNS Disorders • Movement Disorders • Parkinson's Disease