The Ministry of Health has announced the financing of the first continuous subcutaneous infusion treatment based on levodopa (foslevodopa, FLD / foscarbidopa, FCD) for the treatment of advanced Parkinson’s. Marketed as Duodopa, this solution is indicated in patients who respond to levodopa, with severe motor fluctuations and hyperkinesia or dyskinesia when the combinations of medications available for Parkinson’s have not provided satisfactory results.
“This new treatment represents a significant advance in the approach to Parkinson’s disease, as it offers a new non-surgical levodopa-based subcutaneous treatment option that can help control motor symptoms for those living with advanced Parkinson’s disease who sometimes “They often experience challenges as their disease progresses ,” explains Dr. Álvaro Sánchez-Ferro , coordinator of the Movement Disorders Study Group of the Spanish Society of Neurology (SEN), during a press conference organized by the pharmaceutical company Abbvie. , which develops and produces this therapy.
With the financing of this treatment, patients no longer need to undergo surgery for the administration of foslevodopa and foscarbidopa. Instead, the cse patient is implanted with a subcutaneous infusion system for continuous administration over 24 hours. This innovation already represents an improvement in the patient’s quality of life.
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This levodopa-based treatment has proven effective in reducing the most common symptoms of Parkinson’s disease
The treatment has proven effective in reducing the most common symptoms of Parkinson’s disease. Motor symptoms include tremor at rest, bradykinesia, muscle rigidity or balance and posture problems. As for non-motor problems, sleep problems have a prevalence of between 42% and 98%. Other problems may also occur such as depression, anxiety, fatigue or muscle pain. “The symptoms of the disease are often talked about in terms of ON and OFF time. The ON time occurs when the symptoms are controlled and the OFF time is when the symptoms return between doses of the medication ,” adds Dr. Rocío García-Ramos , neurologist at the San Carlos Clinical Hospital in Madrid.
The approval of the treatment is based on two pivotal phase III clinical trials: M15-741 and M-15-736. Primary endpoint results from the first trial showed that adverse events were mostly non-serious and mild/moderate in severity. Secondary endpoint results at week 52 showed improvements in “ON” time without disabling dyskinesia (3.8 ± 3.3 · 3.3 hours) and improvements in “OFF” time relative to initial hours (-3.5 ± 3.1]). For its part, the second trial demonstrated that patients treated with Duodopa showed significant improvements in “ON” time.
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First published in iSanidad. A third-party contributor translated and adapted the article from the original. In case of discrepancy, the original will prevail.
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