: Levodopa is the most efficacious and best-tolerated drug for treating Parkinson's disease (PD). To improve the treatment of PD, recent research initiatives have aimed to optimize the pharmacokinetic plasma behavior of L-dopa. : This non-systematic, narrative drug evaluation brings the therapeutic value of IPX066 up for discussion. IPX066 is an orally applied levodopa/carbidopa containing formulation with modified drug release. It is rapidly absorbed, similar to conventional immediate-release levodopa preparations. The IPX066 capsule continuously releases levodopa during its passage through the gastrointestinal tract. : IPX066 provides more constant therapeutic levodopa plasma concentrations over longer periods. Furthermore, the IPX066 study program showed superior efficacy of IPX066 than conventional oral levodopa/carbidopa preparations for the treatment of motor complications, particularly with OFF intervals. IPX066 also reduced the frequency of oral levodopa intake. IPX066 may also improve the patient´s compliance due to its simplified drug regimen. The marketing of IPX066 outside the US is complex since in countries like Germany, health-care payers only consider innovation in terms of mode of action whereas innovation of pharmacokinetic and pharmacodynamic properties is disregarded.
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http://dx.doi.org/10.1080/14656566.2018.1538355 | DOI Listing |
J Parkinsons Dis
June 2020
Adamas Pharmaceuticals, Inc., Emeryville, CA, USA.
Background: Parkinson's disease (PD) patients using levodopa commonly develop dyskinesia and OFF episodes that reduce quality of life.
Objective: Evaluate prevalence of troublesome dyskinesia and OFF through the day, assessed by 30-minute intervals, as well as the mean number and duration of troublesome dyskinesia and OFF episodes, transitions between PD states, and effects of Gocovri® (amantadine) extended release capsules on these episodes.
Methods: Evaluate diary data from pooled Gocovri phase 3, placebo-controlled trials-analyzed for 17 hours following wake-up-at baseline and week 12.
Parkinsons Dis
October 2018
Impax Laboratories, LLC, 31047 Genstar Road, Hayward, CA 94544, USA.
Background: IPX066 is an extended-release (ER) oral formulation of carbidopa-levodopa (CD-LD). Following an initial peak at about one hour, plasma LD concentrations are maintained for about 4-5 hours.
Objective: To present dosing factors that may affect the successful conversion to ER CD-LD from other LD formulations.
Expert Opin Pharmacother
December 2018
a Department of Neurology , St. Joseph Hospital Berlin-Weißensee, Berlin , Germany.
: Levodopa is the most efficacious and best-tolerated drug for treating Parkinson's disease (PD). To improve the treatment of PD, recent research initiatives have aimed to optimize the pharmacokinetic plasma behavior of L-dopa. : This non-systematic, narrative drug evaluation brings the therapeutic value of IPX066 up for discussion.
View Article and Find Full Text PDFNeuropsychiatr Dis Treat
March 2018
Impax Laboratories, Inc., Hayward, CA, USA.
Background: In patients with Parkinson's disease (PD), oral dosing of extended-release carbidopa-levodopa (Rytary, IPX066 [ER CD-LD]) achieves peak levodopa plasma concentrations within 1 hour and maintains them for 4-6 hours.
Aims: To compare the onset and duration of ER CD-LD benefit with those of immediate-release carbidopa-levodopa (IR CD-LD) in PD patients with motor fluctuations, using crossover data, and to evaluate which threshold values of improvement in finger-tapping and Unified Parkinson's Disease Rating Scale (UPDRS) motor scores yield results most similar to those for trained raters' "on"/"off" assessments.
Methods: Patients underwent serial "on"/"off" rating and provided serial finger-tapping and UPDRS motor scores after receiving, in an "off" state, their usual morning IR dose or an ER dose designed to produce a similar levodopa peak concentration.
Objectives: Extended-release (ER) carbidopa-levodopa (CD-LD) (IPX066/RYTARY/NUMIENT) produces improvements in "off" time, "on" time without troublesome dyskinesia, and Unified Parkinson Disease Rating Scale scores compared with immediate-release (IR) CD-LD or IR CD-LD plus entacapone (CLE). Post hoc analyses of 2 ER CD-LD phase 3 trials evaluated whether the efficacy and safety of ER CD-LD relative to the respective active comparators were altered by concomitant medications (dopaminergic agonists, monoamine oxidase B [MAO-B] inhibitors, or amantadine).
Methods: ADVANCE-PD (n = 393) assessed safety and efficacy of ER CD-LD versus IR CD-LD.
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