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https://www.readbyqxmd.com/read/27743318/novel-levodopa-formulations-for-parkinson-s-disease
#1
Maria Eliza Freitas, Marta Ruiz-Lopez, Susan H Fox
Levodopa remains the most effective treatment for Parkinson's disease and is considered the gold standard therapy. However, disease progression and changes in the gastrointestinal tract result in a declining window of treatment response in a majority of patients. Efforts have been made recently to improve levodopa bioavailability either by developing more effective oral formulations or by innovating routes of administration (intestinal infusion, transcutaneous or inhaled levodopa). IPX066 is a novel levodopa-carbidopa (LD/CD) oral formulation combining immediate-release (IR) and extended-release (ER) LD/CD recently approved in the USA and the EU...
October 14, 2016: CNS Drugs
https://www.readbyqxmd.com/read/27044646/advances-in-levodopa-therapy-for-parkinson-disease-review-of-rytary-carbidopa-and-levodopa-clinical-efficacy-and-safety
#2
REVIEW
Rohit Dhall, David L Kreitzman
Parkinson disease (PD) is a slowly progressive, incurable, neurodegenerative disorder with progressive motor symptoms that can be managed with treatments. Levodopa is generally recognized as the most effective and widely used treatment for PD. It improves function and quality of life, morbidity, and mortality, and therefore reduces individual and societal costs. Levodopa has a relatively short half-life, however, and is quickly metabolized in the plasma, leading to fluctuations, including wearing-off of effect and inconsistent symptomatic relief as well as development of dyskinesias, with both wearing off and dyskinesias worsening with advancing disease...
April 5, 2016: Neurology
https://www.readbyqxmd.com/read/26692288/carbidopa-levodopa-er-capsules-rytary-%C3%A2-numient%C3%A2-a-review-in-parkinson-s-disease
#3
Sarah L Greig, Kate McKeage
A new extended-release (ER) capsule formulation of carbidopa/levodopa (Rytary(®), Numient™, IPX066) is available for the treatment of Parkinson's disease (PD). Carbidopa/levodopa ER capsules contain beads of carbidopa and levodopa, designed to release the drugs at different rates in the gastrointestinal tract and provide constant therapeutic levodopa concentrations that are maintained for 4-5 h (after an initial peak at ≈ 1 h). In randomized phase III trials, oral carbidopa/levodopa ER was significantly more effective than placebo with regard to improving motor symptoms and activities of daily living in patients with early PD after 30 weeks' treatment, and provided significantly greater reductions in daily 'off-time' in patients with advanced PD than immediate-release (IR) carbidopa/levodopa or carbidopa/levodopa IR plus entacapone after a treatment period of 13 and 2 weeks, respectively, without increasing troublesome dyskinesia...
January 2016: CNS Drugs
https://www.readbyqxmd.com/read/26632091/dose-response-analysis-of-the-effect-of-carbidopa-levodopa-extended-release-capsules-ipx066-in-levodopa-naive-patients-with-parkinson-disease
#4
Zhongping Lily Mao, Nishit B Modi
Parkinson disease is an age-related disorder of the central nervous system principally due to loss of dopamine-producing cells in the midbrain. Levodopa, in combination with carbidopa, is widely regarded as an effective treatment for the symptoms of Parkinson disease. A dose-response relationship is established for carbidopa-levodopa extended-release capsules (IPX066) in levodopa-naive Parkinson disease patients using a disease progression model. Unified Parkinson Disease Rating Scale (UPDRS) part II plus part III scores from 171 North American patients treated with placebo or IPX066 for approximately 30 weeks from a double-blind, parallel-group, dose-ranging study were used to develop the pharmacodynamic model...
August 2016: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/26626430/clinical-pharmacokinetics-of-ipx066-evaluation-of-dose-proportionality-and-effect-of-food-in-healthy-volunteers
#5
RANDOMIZED CONTROLLED TRIAL
Hsuan-Ming Yao, Ann Hsu, Suneel Gupta, Nishit B Modi
OBJECTIVES: IPX066 is an oral, extended-release capsule formulation of carbidopa-levodopa (CD-LD) available in 4 strengths. The goals of this investigation were to assess the dose proportionality of IPX066 and to study the effects of a high-fat, high-calorie meal and of sprinkling the capsule contents on applesauce on the pharmacokinetics of IPX066 in healthy volunteers. METHODS: Three open-label studies were conducted. In the first study, subjects received 1 capsule of each IPX066 strength (23...
January 2016: Clinical Neuropharmacology
https://www.readbyqxmd.com/read/26444090/conversion-to-ipx066-from-standard-levodopa-formulations-in-advanced-parkinson-s-disease-experience-in-clinical-trials
#6
RANDOMIZED CONTROLLED TRIAL
Paul A Nausieda, Ann Hsu, Lawrence Elmer, Ramon A Gil, Joerg Spiegel, Carlos Singer, Sarita Khanna, Robert Rubens, Sherron Kell, Nishit B Modi, Suneel Gupta
BACKGROUND: Due to the short half-life of levodopa, immediate-release carbidopa-levodopa (IR CD-LD) produces fluctuating LD concentrations, contributing to a risk of eventual motor complications. IPX066 was designed to rapidly attain therapeutic LD concentrations and maintain them to allow a dosing interval of ∼6 hours. OBJECTIVE: To extensively analyze the dosing data collected in IPX066 studies during open-label conversions from IR CD-LD alone or with entacapone (CLE) and identify patterns relevant for managing conversion in the clinical setting...
2015: Journal of Parkinson's Disease
https://www.readbyqxmd.com/read/26293004/new-treatments-for-levodopa-induced-motor-complications
#7
REVIEW
Olivier Rascol, Santiago Perez-Lloret, Joaquim J Ferreira
Levodopa (l-dopa)-induced motor complications, including motor fluctuations and dyskinesia, affect almost all patients with Parkinson's disease (PD) at some point during the disease course, with relevant implications in global health status. Various dopaminergic and nondopaminergic pharmacological approaches as well as more invasive strategies including devices and functional surgery are available to manage such complications. In spite of undisputable improvements during the last decades, many patients remain significantly disabled, and a fully satisfying management of l-dopa-induced motor complications is still an important unmet need of PD therapy...
September 15, 2015: Movement Disorders: Official Journal of the Movement Disorder Society
https://www.readbyqxmd.com/read/25855267/comparison-of-the-pharmacokinetics-of-an-oral-extended-release-capsule-formulation-of-carbidopa-levodopa-ipx066-with-immediate-release-carbidopa-levodopa-sinemet-%C3%A2-sustained-release-carbidopa-levodopa-sinemet-%C3%A2-cr-and-carbidopa-levodopa-entacapone-stalevo-%C3%A2
#8
RANDOMIZED CONTROLLED TRIAL
Ann Hsu, Hsuan-Ming Yao, Suneel Gupta, Nishit B Modi
IPX066 (extended-release carbidopa-levodopa [ER CD-LD]) is an oral extended-release capsule formulation of carbidopa and levodopa. The single-dose pharmacokinetics of ER CD-LD (as 2 capsules; total dose, 97.5 mg-390 mg CD-LD) versus immediate-release (IR) CD-LD (25 mg-100 mg), sustained-release (CR) CD-LD (25 mg-100 mg), and CD-LD-entacapone (25 mg-100 mg-200 mg) was evaluated in healthy subjects. Following IR dosing, LD reached peak concentrations (Cmax ) at 1 hour; LD concentrations then decreased rapidly and were less than 10% of peak by 5 hours...
September 2015: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/25697185/safety-of-ipx066-an-extended-release-carbidopa-levodopa-formulation-for-the-treatment-of-parkinson-s-disease
#9
REVIEW
Meir Kestenbaum, Stanley Fahn
INTRODUCTION: Levodopa (LD) is the most effective treatment for Parkinson's disease (PD). However, chronic use of LD commonly results in the development of motor complications, including wearing off and dyskinesia. The presumption that the short serum half-life of LD is associated with the development of motor complications has raised the need to develop treatments with increased durations of stable LD concentrations. AREAS COVERED: We conducted a PubMed search for IPX066 articles and also reviewed abstracts from meetings that included this topic...
May 2015: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/25476691/novel-formulations-and-modes-of-delivery-of-levodopa
#10
REVIEW
Werner Poewe, Angelo Antonini
Ever since its early clinical use in the 1960s, levodopa has remained the gold standard of symptomatic efficacy in the drug treatment of Parkinson's disease (PD). Motor response fluctuations and drug-induced dyskinesias seriously compromise the unparalleled symptomatic efficacy of l-dopa during long-term treatment. Discontinuous drug delivery resulting from the short half-life of l-dopa and erratic gastrointestinal absorption plays a major role in the pathophysiology of these motor complications. Several approaches to improve the pharmacokinetics and ways of administration of l-dopa are in different stages of clinical development and include novel formulations as well as nonoral routes of drug delivery...
January 2015: Movement Disorders: Official Journal of the Movement Disorder Society
https://www.readbyqxmd.com/read/25306200/comparison-of-ipx066-with-carbidopa-levodopa-plus-entacapone-in-advanced-pd-patients
#11
RANDOMIZED CONTROLLED TRIAL
Fabrizio Stocchi, Ann Hsu, Sarita Khanna, Aaron Ellenbogen, Andreas Mahler, Grace Liang, Ulrich Dillmann, Robert Rubens, Sherron Kell, Suneel Gupta
BACKGROUND: IPX066, an investigational extended-release carbidopa-levodopa (CD-LD) preparation, has demonstrated a rapid attainment and prolonged maintenance of therapeutic LD plasma concentrations in advanced Parkinson's disease (PD). This phase-3 crossover study assessed its efficacy and safety vs. CD-LD plus entacapone (CL + E). METHODS: At baseline, all patients had motor fluctuations despite a stable regimen of CL + E or CD-LD-entacapone combination tablets (CLE)...
December 2014: Parkinsonism & related Disorders
https://www.readbyqxmd.com/read/25146967/ipx066-a-mixed-immediate-sustained-release-levodopa-preparation-for-parkinson-s-disease
#12
REVIEW
William Ondo
INTRODUCTION: L-DOPA has long been the 'gold standard' treatment for Parkinson's disease (PD), but suffers from poor oral bioavailability and rapid pharmacokinetic elimination. A longer acting preparation has long been sought. AREAS COVERED: We conducted PubMed search for IPX066 and reviewed abstracts from meetings that included the topic of PD. IPX066 is a novel mixed immediate release (IR) and sustained-release levodopa preparation designed to prolong the clinical effect of a single dose...
October 2014: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/24950010/treatment-of-early-parkinson-s-disease
#13
REVIEW
Rajesh Pahwa, Kelly E Lyons
PURPOSE OF REVIEW: This review summarizes currently available treatment options and treatment strategies, investigational treatments, and the importance of exercise for early Parkinson's disease. RECENT FINDINGS: The available treatment options for early Parkinson's disease have changed little in the past decade and include carbidopa/levodopa, dopamine agonists, and monoamine oxidase type B (MAO-B) inhibitors. However, we discuss changes in treatment strategies, including dosing and the use of combination therapy used in an attempt to reduce or delay the appearance of motor complications and other adverse events...
August 2014: Current Opinion in Neurology
https://www.readbyqxmd.com/read/24501594/ipx066-a-new-intermediate-and-extended-release-carbidopa-levodopa-formulation
#14
Talene A Yacoubian
Carbidopa-levodopa (CD-LD) is the mainstay of treatment for Parkinson's disease (PD), yet most patients with advanced PD develop motor fluctuations with time when treated with CD-LD. Development of longer-acting CD-LD formulations is a major goal for reducing motor fluctuations in advanced PD. IPX066 is a new formulation of CD-LD that contains both an immediate-release and a sustained-release levodopa component, which is currently under review by the US FDA. Recent clinical trials have demonstrated improved effectiveness of IPX066 compared with other CD-LD formulations in advanced PD, with a reduction in 'off' time of approximately 37%...
April 1, 2013: Neurodegenerative Disease Management
https://www.readbyqxmd.com/read/24428803/novel-levodopa-formulations-in-the-treatment-of-parkinson-s-disease
#15
REVIEW
Manuela Pilleri, Angelo Antonini
Levodopa is the gold standard in Parkinson's disease (PD) treatment but its use is associated with motor complications. Levodopa pharmacokinetics, a short half-life, erratic gastric emptying and duodenal absorption, are key factors in their pathogenesis. As the disease progresses, frequency of levodopa administrations is increased leading to a complex treatment schedule and poor patient compliance. The development of long acting formulations ensuring continuous delivery is therefore crucial to improve daily motor control...
February 2014: Expert Review of Neurotherapeutics
https://www.readbyqxmd.com/read/24055014/randomized-trial-of-ipx066-carbidopa-levodopa-extended-release-in-early-parkinson-s-disease
#16
RANDOMIZED CONTROLLED TRIAL
Rajesh Pahwa, Kelly E Lyons, Robert A Hauser, Stanley Fahn, Joseph Jankovic, Emmanuelle Pourcher, Ann Hsu, Martin O'Connell, Sherron Kell, Suneel Gupta
OBJECTIVE: IPX066 is an extended release carbidopa/levodopa formulation designed to rapidly attain and maintain therapeutic plasma concentrations for a prolonged duration, allowing dosing intervals of approximately 6 h. The objective was to assess the efficacy, safety, and impact on quality of life of IPX066 in the treatment of levodopa-naive Parkinson's disease (PD) patients. METHODS: This was a randomized, double-blind, placebo-controlled, 30-week study of 381 levodopa-naïve patients assigned to placebo or IPX066 containing 145, 245 or 390 mg of levodopa administered three times daily (TID)...
February 2014: Parkinsonism & related Disorders
https://www.readbyqxmd.com/read/24018435/-pharmacotherapy-of-parkinson-s-disease-progress-or-regress
#17
REVIEW
Karolina Pytka, Małgorzata Zygmunt, Barbara Filipek
Parkinson's disease (PD) is a chronic, progressive disease of the central nervous system (CNS), characterized by a slow loss of dopaminergic neurons in the substantia nigra, leading to significant decrease in dopamine (DA) levels in the striatum. Currently used drugs, such as levodopa (L-DOPA), amantadine, dopamine agonists (D) or anticholinergic drugs, are not effective enough, and do not eliminate the causes of disease. Many research centers are conducting research on new forms of currently used drugs (e...
2013: Postȩpy Higieny i Medycyny Doświadczalnej
https://www.readbyqxmd.com/read/23739008/continuous-dopaminergic-delivery-to-minimize-motor-complications-in-parkinson-s-disease
#18
Brenton A Wright, Cheryl H Waters
Motor fluctuations and dyskinesias are common sequelae of Parkinson's disease (PD) that may limit function and quality of life. With disease progression, striatal dopamine concentration becomes closely linked to plasma levodopa levels, which vary considerably with standard oral regimens. Exposure of striatal dopamine receptors to wildly fluctuating transmitter levels is thought to contribute to the development of dyskinesias and motor fluctuations. Continuous dopaminergic delivery has been shown to reduce motor complications in advanced PD patients, and has been hypothesized to prevent their incidence when given as early therapy in mild PD...
June 2013: Expert Review of Neurotherapeutics
https://www.readbyqxmd.com/read/23485610/extended-release-carbidopa-levodopa-ipx066-compared-with-immediate-release-carbidopa-levodopa-in-patients-with-parkinson-s-disease-and-motor-fluctuations-a-phase-3-randomised-double-blind-trial
#19
RANDOMIZED CONTROLLED TRIAL
Robert A Hauser, Ann Hsu, Sherron Kell, Alberto J Espay, Kapil Sethi, Mark Stacy, William Ondo, Martin O'Connell, Suneel Gupta
BACKGROUND: IPX066 is an oral, extended-release, capsule formulation of carbidopa-levodopa. We aimed to assess this extended-release formulation versus immediate-release carbidopa-levodopa in patients with Parkinson's disease and motor fluctuations. METHODS: We did a phase 3, randomised, double-blind, double-dummy study at 68 academic and clinical centres in North America and Europe. Patients with Parkinson's disease who had at least 2·5 h per day of off-time underwent 3 weeks of open-label immediate-release carbidopa-levodopa dose adjustment followed by 6 weeks of open-label extended-release carbidopa-levodopa dose conversion...
April 2013: Lancet Neurology
https://www.readbyqxmd.com/read/23426902/population-pharmacodynamics-of-ipx066-an-oral-extended-release-capsule-formulation-of-carbidopa-levodopa-and-immediate-release-carbidopa-levodopa-in-patients-with-advanced-parkinson-s-disease
#20
RANDOMIZED CONTROLLED TRIAL
Zhongping Mao, Ann Hsu, Suneel Gupta, Nishit B Modi
A pharmacodynamic model is presented to describe the motor effects (tapping rate, Unified Parkinson's Disease Rating Scale [UPDRS] Part III, and investigator-rating of ON/OFF, including dyskinesia) of levodopa (LD) in patients with advanced idiopathic Parkinson's disease (PD) treated with immediate-release (IR) carbidopa-levodopa (CD-LD) or an extended-release (ER) formulation of CD-LD (IPX066). Twenty-seven patients participated in this open-label, randomized, single- and multiple-dose, crossover study. The pharmacodynamic models included a biophase effect site with a sigmoid E(max) transduction for tapping and UPDRS and an ordered categorical model for dyskinesia...
May 2013: Journal of Clinical Pharmacology
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