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Due to the progressive nature of Parkinson’s disease, “oral medications are eventually no longer as effective at motor symptom control and surgical treatment may be required. This new, non-surgical regimen provides continuous delivery of levodopa morning, day, and night,” Robert A. Hauser, MD, MBA, director of the Parkinson’s and Movement Disorder Center at the University of South Florida, Tampa, said in a news release.
The FDA approval was supported by results of a 12-week, phase 3 study evaluating the efficacy of continuous subcutaneous infusion foscarbidopa/foslevodopa in adults with advanced Parkinson’s disease compared with oral immediate-release carbidopa/levodopa.
The study showed that patients treated with foscarbidopa/foslevodopa had superior improvement in motor fluctuations, with increased “on” time without troublesome dyskinesia and decreased “off” time, compared with peers receiving oral immediate-release carbidopa/levodopa.
At week 12, the increase in “on” time without troublesome dyskinesia was 2.72 hours for foscarbidopa/foslevodopa continuous infusion versus 0.97 hours for carbidopa/levodopa (P =.0083).
Improvements in “on” time were observed as early as the first week and persisted throughout the 12 weeks.
The approval of foscarbidopa/foslevodopa for advanced Parkinson’s disease was also supported by a 52-week, open-label study which evaluated the long-term safety and efficacy of the drug.
Most adverse reactions with foscarbidopa/foslevodopa were non-serious and mild or moderate in severity. The most frequent adverse reactions were infusion site events, hallucinations, and dyskinesia.
Full prescribing information is available online.
AbbVie said coverage for Medicare patients is expected in the second half of 2025.
A version of this article appeared on Medscape.com.
Due to the progressive nature of Parkinson’s disease, “oral medications are eventually no longer as effective at motor symptom control and surgical treatment may be required. This new, non-surgical regimen provides continuous delivery of levodopa morning, day, and night,” Robert A. Hauser, MD, MBA, director of the Parkinson’s and Movement Disorder Center at the University of South Florida, Tampa, said in a news release.
The FDA approval was supported by results of a 12-week, phase 3 study evaluating the efficacy of continuous subcutaneous infusion foscarbidopa/foslevodopa in adults with advanced Parkinson’s disease compared with oral immediate-release carbidopa/levodopa.
The study showed that patients treated with foscarbidopa/foslevodopa had superior improvement in motor fluctuations, with increased “on” time without troublesome dyskinesia and decreased “off” time, compared with peers receiving oral immediate-release carbidopa/levodopa.
At week 12, the increase in “on” time without troublesome dyskinesia was 2.72 hours for foscarbidopa/foslevodopa continuous infusion versus 0.97 hours for carbidopa/levodopa (P =.0083).
Improvements in “on” time were observed as early as the first week and persisted throughout the 12 weeks.
The approval of foscarbidopa/foslevodopa for advanced Parkinson’s disease was also supported by a 52-week, open-label study which evaluated the long-term safety and efficacy of the drug.
Most adverse reactions with foscarbidopa/foslevodopa were non-serious and mild or moderate in severity. The most frequent adverse reactions were infusion site events, hallucinations, and dyskinesia.
Full prescribing information is available online.
AbbVie said coverage for Medicare patients is expected in the second half of 2025.
A version of this article appeared on Medscape.com.
Due to the progressive nature of Parkinson’s disease, “oral medications are eventually no longer as effective at motor symptom control and surgical treatment may be required. This new, non-surgical regimen provides continuous delivery of levodopa morning, day, and night,” Robert A. Hauser, MD, MBA, director of the Parkinson’s and Movement Disorder Center at the University of South Florida, Tampa, said in a news release.
The FDA approval was supported by results of a 12-week, phase 3 study evaluating the efficacy of continuous subcutaneous infusion foscarbidopa/foslevodopa in adults with advanced Parkinson’s disease compared with oral immediate-release carbidopa/levodopa.
The study showed that patients treated with foscarbidopa/foslevodopa had superior improvement in motor fluctuations, with increased “on” time without troublesome dyskinesia and decreased “off” time, compared with peers receiving oral immediate-release carbidopa/levodopa.
At week 12, the increase in “on” time without troublesome dyskinesia was 2.72 hours for foscarbidopa/foslevodopa continuous infusion versus 0.97 hours for carbidopa/levodopa (P =.0083).
Improvements in “on” time were observed as early as the first week and persisted throughout the 12 weeks.
The approval of foscarbidopa/foslevodopa for advanced Parkinson’s disease was also supported by a 52-week, open-label study which evaluated the long-term safety and efficacy of the drug.
Most adverse reactions with foscarbidopa/foslevodopa were non-serious and mild or moderate in severity. The most frequent adverse reactions were infusion site events, hallucinations, and dyskinesia.
Full prescribing information is available online.
AbbVie said coverage for Medicare patients is expected in the second half of 2025.
A version of this article appeared on Medscape.com.