Levodopa/carbidopa/entacapone (Lecigon) - Parkinson's disease Final Appraisal Recommendation Advice number: 0223 – April 2023 Levodopa-carbidopa-entacapone (Lecigon®) 20 mg/ml + 5 mg/ml + 20 mg/ml intestinal gel Submission by Britannia Pharmaceuticals Ltd This product is not currently marketed in the UK Recommendation of the All Wales Medicines Strategy Group Levodopa-carbidopa -entacapone (Lecigon®) is recommended as an option for restricted use within NHS Wales. Levodopa-carbidopa-entacapone (Lecigon®) is licensed for the treatment of advanced Parkinson’s disease with severe motor fluctuations and hyperkinesia or dyskinesia when available oral combinations of Parkinson medicinal products have not given satisfactory results. Levodopa-carbidopa-entacapone (Lecigon®) is restricted
Levodopa/carbidopa/entacapone (Lecigon) - advanced Parkinson's disease 1 Published 09 December 2024 1 SMC2507 levodopa 20mg/mL + carbidopa monohydrate 5mg/mL + entacapone 20mg/mL intestinal gel (Lecigon®) Britannia Pharmaceuticals Ltd 10 January 2023 (Issued 08 November 2024) The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use in NHSScotland. The advice is summarised as follows: ADVICE: following a full submission assessed under the orphan equivalent medicine process levodopa 20mg/mL + carbidopa monohydrate 5mg/mL + entacapone 20mg/mL intestinal gel (Lecigon®) is not recommended for use within NHSScotland. Indication under review: treatment of advanced Parkinson's disease
The efficacy of levodopa/carbidopa/entacapone on cognitive function in moderate to advanced Parkinson's disease and its relationship with peripheral inflammatory cytokines. Entacapone has been widely used in the treatment of moderate to advanced Parkinson's disease (PD), and its efficacy for motor symptoms has been well-known from several clinical trials and long-term clinical use. The efficacy of Levodopa/Carbidopa/Entacapone (LCE) on neuropsychological functions in moderate to advanced PD has not been validated yet, and little is known about the effect of LCE on peripheral inflammatory cytokines. The aim of this study was to investigate the efficacy of LCE on neuropsychological functions in moderate to advanced PD and to explore its relationship with the changes in peripheral inflammatory
Comparison of two types of extension tubes for people with Parkinson's disease in advanced treatment with levodopa-entacapone-carbidopa intestinal gel infusions: a prospective, crossover quality study. Within Parkinson's disease (PD) management, a pivotal juncture often arises when individuals with PD (PwP) necessitate advanced therapies to stabilise symptom fluctuations and reduce off-periods , which are intrinsic to living with PD. One such intervention is the infusion of duodenal levodopa-entacapone-carbidopa intestinal gel (LECIG), which confers a more dependable levodopa plasma concentration compared with conventional oral therapy. It involves the insertion of a percutaneous endoscopic gastrojejunostomy (PEG-J) tube, facilitating direct access to the stomach and jejunum. Then, a slender
Using Multiple Authorized Generics to Maintain High Prices: The Example of Entacapone. Brand-name drug manufacturers can market or license authorized generics (AGs), which are the same product sold under a generic name. By contrast, independent generics (IGs) are made by other manufacturers. The brand-name manufacturer of entacapone, a treatment for Parkinson's disease, established 4 AGs before IGs emerged. We used this case study to understand how AGs can affect the length of brand-name exclusivity and robustness of generic competition. Using public Food and Drug Administration and court records, we identified the regulatory and legal history for generic entacapone products marketed through 2021. We used Medicare Part D data to estimate trends in use, prices, and spending on entacapone
Effects of vitamin B12, folate, and entacapone on homocysteine levels in levodopa-treated Parkinson's disease patients: A randomized controlled study. Previous studies have suggested a significant increase in plasma homocysteine (Hcy) levels in levodopa-treated Parkinson's disease (PD) patients, and vitamin B12 and folate supplementation may decrease Hcy levels. However, the effects of catechol -O-methyltransferase inhibitors on levodopa-induced increase in Hcy levels were conflicting. The aim of this study was to evaluate whether Hcy levels are increased in levodopa-treated PD patients and to evaluate the effects of vitamin B12 and folate or entacapone on Hcy levels in levodopa-treated PD patients. We analyzed and compared plasma Hcy levels in 20 levodopa-naïve PD patients and 42
Entacapone An official website of the United States government Here's how you know Log inAccess keysNCBI HomepageMyNCBI HomepageMain ContentMain NavigationBookshelfSearch databaseBooksAll DatabasesAssemblyBiocollectionsBioProjectBioSampleBooksClinVarConserved DomainsdbGaPdbVarGeneGenomeGEO DataSetsGEO ProfilesGTRHomoloGeneIdentical Protein GroupsMedGenMeSHNLM LactationNo information is available on the use of entacapone during breastfeeding. An alternate drug may be preferred, especially while nursing a newborn or preterm infant.Drug LevelsMaternal Levels. Relevant published information was not found as of the revision date.Infant Levels. Relevant published information was not found as of the revision date.Effects in Breastfed InfantsRelevant published
Population pharmacokinetics of levodopa gel infusion in Parkinson's disease: effects of entacapone infusion and genetic polymorphism. Levodopa-entacapone-carbidopa intestinal gel (LECIG) provides continuous drug delivery through intrajejunal infusion. The aim of this study was to characterize the population pharmacokinetics of levodopa following LECIG and levodopa-carbidopa intestinal gel (LCIG , and apparent volume of distribution of 74.4 L/70 kg. Our results thus suggest that the continuous maintenance dose of LECIG, on a population level, should be decreased by approximately 35%, to achieve similar drug exposure as with LCIG. An effect from entacapone was identified on all individuals, regardless of COMT rs4680 genotype. The individuals with higher DDC and COMT enzyme activity showed tendencies
Increased dose of carbidopa with levodopa and entacapone improves off time in a randomized trial To investigate whether increased fixed carbidopa doses of 65 or 105 mg (ODM-101/65 and ODM-101/105) in combination with 75, 100, 125, or 150 mg of levodopa and 200 mg of entacapone might improve "off" time in fluctuating Parkinson disease (PD) compared to the standard combination of 4:1 levodopa /carbidopa with the usual 200 mg of entacapone (LCE) during a 4-week treatment period. This was a randomized, double-blind, double-dummy, active-controlled, crossover, multicenter, phase II, proof-of-concept study in patients with fluctuating PD. One hundred seventeen patients were randomized into the study (mean age 67.0 years; daily "off" time 5.3 hours; mean daily levodopa dose 610 mg). Carryover
Levodopa dose maintenance or reduction in patients with Parkinson's disease transitioning to levodopa/carbidopa/entacapone. Levodopa bioavailability is enhanced by adding entacapone. However, the optimal dose of levodopa while transitioning to levodopa/carbidopa/entacapone (LCE) in Parkinson's disease (PD) during the wearing-off period is unclear. The relative therapeutic efficacy and safety
Effectiveness of opicapone and switching from entacapone in fluctuating Parkinson disease. To evaluate the effectiveness of opicapone as add-on to levodopa and the effects of switching from entacapone over 1 year of treatment in patients with fluctuating Parkinson disease. After completion of a placebo- and entacapone-controlled double-blind study of opicapone (5, 25, or 50 mg), 495 patients , and -23.0 minutes for switching from placebo, entacapone, and opicapone 5 and 25 mg, respectively). Dyskinesia was the most frequently reported adverse event (14.5%) and was managed by adjustment of dopaminergic therapy. No new safety concerns were observed with long-term opicapone administration. Long-term use of opicapone provided sustained efficacy over 1 year. Switching from entacapone to opicapone
Efficacy and Safety of Entacapone Combined With Madopar in the Treatment of Early Parkinson's Disease (PD): A Prospective, Multicenter, Non-Randomized Controlled Study This study aims to evaluate the efficacy and safety of combining entacapone with Madopar (levodopa/benserazide) in the treatment of early-stage Parkinson's disease (PD). Levodopa is the most effective medication for PD, but long -term use often causes motor complications due to its short half-life. Entacapone is a COMT inhibitor that can prolong levodopa's effect and stabilize its blood levels. This prospective, multicenter, non-randomized controlled study will recruit early PD patients and assign them to either a Madopar-only group or a Madopar plus entacapone group. Participants will be treated for 24 weeks. The primary
Entacapone Teva 7 Westferry Circus ● Canary Wharf ● London E14 4HB ● United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8545 E-mail info@ema.europa.eu Website www.ema.europa.eu An agency of the European Union EMA/52316/2011 Committee for medicinal products for human use (CHMP) Assessment Report For Entacapone Teva (entacapone) Procedure No.: EMEA/H/C/002075 2010 an application for Marketing Authorisation to the European Medicines Agency (EMA) for Entacapone Teva, through the centralised procedure falling within the scope of the Article 3 (3) – ‘Generic of a Centrally authorised product’, of Regulation (EC) No. 726/2004. The eligibility to the centralised procedure was agreed upon by the EMA/CHMP on 24 June 2009. The applicant applied for the following
Basic and Clinical Studies of Levodopa/Carbidopa/Entacapone in the Treatment of Early Parkinson's Disease This is a, open-label, single-arm 8-week investigation of levodopa/carbidopa/entacapone in the treatment of early Parkinson's disease. This study will enroll subjects who have a diagnosis of PD with Hoehn-Yahr stage 1.5-3.0 and assess the impact of low dosage of levodopa/carbidopa/entacapone
Bioequivalence Study of Entacapone,Levodopa and Carbidopa Tablets in the Postprandial State in Healthy Chinese Subjects In this trial, 36 healthy subjects are planned to be enrolled in postprandial, and the postprandial trials will be randomized separately. According to the randomization table, subjects will be randomly assigned to one of the two groups (Group A: TRTR, Group B: RTRT). The washout
Effects of levodopa-carbidopa-entacapone and smoked cocaine on facial affect recognition in cocaine smokers. In addition to difficulties in daily social functioning, regular cocaine users have decrements in social processing (the cognitive and affective processes underlying social behavior) relative to non-users. Little is known, however, about the effects of clinically-relevant pharmacological agents, such as cocaine and potential treatment medications, on social processing in cocaine users. Such drug effects could potentially alleviate or compound baseline social processing decrements in cocaine abusers. Here, we assessed the individual and combined effects of smoked cocaine and a potential treatment medication, levodopa-carbidopa-entacapone (LCE), on facial emotion recognition in cocaine
Levodopa-entacapone-carbidopa intestinal gel in Parkinson's disease: A randomized crossover study. The addition of oral entacapone to levodopa-carbidopa intestinal gel treatment leads to less conversion of levodopa to 3-O-methyldopa, thereby increasing levodopa plasma concentration. The objective of this study was to compare systemic levodopa exposure of the newly developed levodopa-entacapone was assessed according to the treatment response scale. Systemic exposure of levodopa did not differ significantly between treatments (ratio, 1.10 [95% confidence interval, 0.951-1.17]). Treatment response scale scores did not significantly differ between treatments (P = 0.84). Levodopa-entacapone-carbidopa intestinal gel allowed a lower amount of levodopa administration and was well tolerated. Long-term