Abbvie announces EU launch of PRODUODOPA® , a 24-hour infusion of levodopa-based therapy for the treatment of advanced Parkinson's disease
Published on MedED: 18 January 2024
Originally published: 8 January 2024
Source: Abbvie.com
Type of article: Novel Drug & Emergent Therapy News
MedED Catalogue Reference: MNDN001
Category: Neurology
Crossreference: Gerontology
Category tags: Parkinson's, tremor, tremor, hyperkinesia, dyskinesia
Originally published: 8 January 2024
Source: Abbvie.com
Type of article: Novel Drug & Emergent Therapy News
MedED Catalogue Reference: MNDN001
Category: Neurology
Crossreference: Gerontology
Category tags: Parkinson's, tremor, tremor, hyperkinesia, dyskinesia
| Product Category | Product Name | Company | Status |
|---|---|---|---|
|
Pharmacuetical |
PRODUODOPA® |
EU Approved |
NORTH CHICAGO, Ill., Jan. 9, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV)
AbbVie has announced the introduction of PRODUODOPA® (foslevodopa/foscarbidopa) in the European Union.
PRODUODOPA® (foslevodopa/foscarbidopa) is the first and only subcutaneous 24-hour infusion of levodopa-based therapy for the treatment of advanced Parkinson's disease in patients where existing combinations of medicinal products for Parkinson's have been insufficient or not produced satisfactory results.
The continuous delivery of PRODUODOPA provides levodopa 24 hours a day, which may help patients by extending the period when symptoms are well-controlled, often referred to as "On" time.2
According to the company statement released on the 9th of January, the launch in the EU was supported by three key studies: a Phase 3, 12-month open-label study (M15-741) which assessed the long-term safety, tolerability, and efficacy of continuous subcutaneous infusion of PRODUODOPA; a Phase 3, 12-week study (M15-736) which compared the efficacy and safety of PRODUODOPA to oral levodopa/carbidopa, and a Phase 1 pharmacokinetic comparability study.
Results from the M15-741 study showed a favourable benefit/risk profile, revealing sustained improvements in "Off" time, "On" time without dyskinesia, and morning akinesia. The majority of adverse events with PRODUODOPA were non-serious, mild, or moderate, with everyday events including infusion site issues, hallucinations, falls, and anxiety.
Clinical Trials & Supporting Information
| Clinical Study | ClinicalTrial.gov Registration | ClinicalTrial.gov Registration |
|---|---|---|
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This article is compiled from a variety of resources. Every effort has been made to correctly attribute quotes and content. Where possible all information has been independently verified. The Medical Education Network bears no responsibility for any inaccuracies which may occur from the use of third-party sources. If you have any queries regarding this article contact us
Fact-checking Policy
The Medical Education Network makes every effort to review and fact-check the articles used as source material in our summaries and original material. We have strict guidelines in relation to the publications we use as our source data, favouring peer-reviewed research wherever possible. Every effort is made to ensure that the information contained here is an accurate reflection of the original material. Should you find inaccuracies, out of date content or have any additional issues with our articles, please make use of the contact us form to notify us.
