Twenty parkinsonian patients were treated with controlled-release carbidopa/levodopa (Sinemet CR). All were affected by therapeutic response fluctuations related to the timing of drug administration. The daily dosage after 1 year, 766 mg +/- 250 mg, was increased by 23% compared with standard Sinemet dosage, without additional secondary effects. Parkinsonian scores improved by 43%; the prolongation of "on" periods was 63%. Nevertheless, 7 patients withdrew from this study during the 1st month of treatment. Only 1 withdrew due to an adverse reaction to the formulation, a recurrence of hallucinations. The progressive effect of the 1st morning dose and the often unpredictable time at which the product first takes effect were found to be frustrating for the other patients who withdrew. We believe that this disappointment can be avoided by giving new patients the controlled-release formulation from the start of therapy.
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Eur J Pharm Biopharm
October 2024
Hospital Pharmacy Unit, Azienda Provinciale Per i Servizi Sanitari, Largo Medaglie d'oro 9, Trento, Italy. Electronic address:
Background: sepiapterine reductase deficiency (SRD) is a rare levodopa (L-dopa)-responsive disorder treated with a combination therapy of controlled-release L-dopa and carbidopa. The currently available formulation of controlled-release carbidopa/L-dopa does not entirely meet the requirements for the long-term therapy in pediatric patients. In fact, administration of a manufactured tablet at a dose intended for adults necessitates its adjustment to the child's needs, as the splitting of the tablet into smaller portions or its dilution in water.
View Article and Find Full Text PDFJAMA Neurol
October 2023
Amneal Pharmaceuticals, Bridgewater, New Jersey.
Importance: Levodopa has a short half-life and a limited window of opportunity for absorption in the proximal small intestine. IPX203 is an oral, extended-release formulation of carbidopa-levodopa developed to address these limitations.
Objective: To assess the efficacy and safety of IPX203 vs immediate-release carbidopa-levodopa in patients with Parkinson disease who are experiencing motor fluctuations.
Clin Neuropharmacol
October 2021
Department of Neurology, O'Donnell Brain Institute, UT Southwestern Medical Center, Dallas, TX.
Objective: Motor fluctuations develop in most patients treated with carbidopa/levodopa for Parkinson disease. The continuous dopamine stimulation hypothesis suggests that longer-acting forms of levodopa might improve outcomes, but this has been inadequately tested in humans. We undertook to determine if there is any difference in symptom progression rate among patients taking immediate-release carbidopa/levodopa (IR), controlled-release carbidopa/levodopa (CR), or carbidopa/levodopa/entacapone (CLE) using standard outcome measures in a naturalistic study.
View Article and Find Full Text PDFParkinsonism Relat Disord
August 2019
Intec Pharma, Ltd, Hartom 12, POB 45219, Jerusalem, 91450, Israel.
Introduction: Dopamine replacement via levodopa (LD) remains the most effective treatment for Parkinson's disease (PD), yet its use is often associated with motor complications within several years of continued use. The Accordion Pill (AP-CD/LD) is a novel drug delivery system based on gastric retention of multilayer films containing immediate-release (IR) carbidopa (CD) and immediate- and controlled-release LD. The AP-CD/LD was designed to improve the consistency of LD in the bloodstream while offering patients with PD more consistent symptom management.
View Article and Find Full Text PDFJ Neurol Sci
February 2017
Impax Laboratories, Inc., 31047 Genstar Road, Hayward, CA 94544, USA. Electronic address:
Background: IPX066 (Rytary®; carbidopa and levodopa [CD-LD] extended-release capsules) was designed to achieve therapeutic LD plasma concentrations within 1h of dosing and maintain LD concentrations for a prolonged duration in early or advanced Parkinson's disease (PD).
Methods: In this open-label study, patients underwent 6weeks of conversion to IPX066 from their prior controlled-release (CR)±immediate-release (IR) CD-LD therapy and 6months of maintenance (with an additional 6months of IPX066 at some sites). Clinical utility was assessed at both the end of conversion and maintenance.
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