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by xavier.grehant on 2026-05-18

Pump therapies (LCIG, apomorphine) On/off fluctuations Dyskinesia Gait & freezing Pain Insomnia Levodopa formulations Trial readouts

Vyalev (also sold as Produodopa in Europe) is a therapy made by AbbVie that delivers levodopa and carbidopa — the standard Parkinson's medications — continuously under the skin via a small pump, 24 hours a day. Unlike oral pills, which cause levodopa levels in the blood to rise and fall with each dose, the pump keeps levels steadier. This matters because those peaks and troughs are what drive two of the most disabling problems in advanced Parkinson's: off episodes (periods when medication stops working and symptoms return, sometimes suddenly) and dyskinesia (involuntary, uncontrolled movements caused by too much levodopa at once).

The article reports six-month interim results from ROSSINI (NCT06107426), an ongoing real-world observational study following 427 adults with advanced Parkinson's across 10 countries in routine clinical care — not a tightly controlled lab trial, but an important first look at how the therapy performs in everyday practice. Among the 105 newly treated participants with evaluable data, daily off time dropped by an average of 2.8 hours (about 53%), and daily dyskinesia time fell by 1.8 hours (also roughly 53%). Standard motor scores improved significantly, freezing of gait lessened, and nonmotor symptoms — pain, sleep disturbances, and gut problems — also got better. Quality of life scores improved, especially in mobility, emotional well-being, and physical comfort. About a third of participants stopped treatment within six months, most commonly due to personal choice or side effects; hallucinations and skin infections at the infusion site each affected around 6% of patients.

For someone living with advanced Parkinson's who still experiences hours of daily off time despite optimised oral medication, this real-world data adds meaningful reassurance that Vyalev performs outside of clinical trials similarly to how it did inside them. It is already approved in the US and Europe, so this is a conversation you can have with your neurologist now — not a future hope. The key question to raise is whether your off-time burden justifies moving to a pump, and whether the practical demands (wearing a device 24/7, managing infusion-site care) are right for your situation. A 12-month interim analysis of 200 patients is planned next, which will give a clearer picture of longer-term tolerability.

What this article adds

Pump therapies (LCIG, apomorphine)
Six-month real-world data from the ROSSINI observational study (n=105 newly treated patients) show Vyalev (foslevodopa/foscarbidopa subcutaneous infusion) cut daily off time by ~53% and dyskinesia time by ~53% in advanced Parkinson's — the first prospective real-world evidence for this pump therapy since its recent approval.
On/off fluctuations
ROSSINI interim data show that 24-hour continuous subcutaneous Vyalev infusion reduced mean daily off time from ~5.2 hours to ~2.4 hours at six months in real-world advanced Parkinson's patients, supporting the clinical-trial efficacy signal in a routine-care setting.
Dyskinesia
In the ROSSINI real-world study, daily dyskinesia time fell by an average of 1.8 hours (53%) after six months on Vyalev, consistent with the smoother levodopa delivery reducing peak-dose involuntary movements outside of controlled trial conditions.
Gait & freezing
ROSSINI six-month data showed a significant reduction in freezing of gait among advanced Parkinson's patients on Vyalev, adding real-world evidence that continuous levodopa delivery may ease this particularly disabling motor symptom.
Pain
The ROSSINI study found that Vyalev significantly reduced pain scores in advanced Parkinson's patients after six months, one of the few real-world datasets to document a nonmotor benefit of continuous subcutaneous levodopa infusion on pain specifically.
Insomnia
ROSSINI interim results reported significant improvement in sleep disturbances after six months of 24-hour Vyalev infusion in advanced Parkinson's, suggesting that stabilising overnight levodopa levels may contribute to better sleep in this population.
Levodopa formulations
ROSSINI provides the first prospective real-world effectiveness data for foslevodopa/foscarbidopa (Vyalev) — a subcutaneous prodrug formulation — showing comparable efficacy to its Phase 3 trial results and a safety profile consistent with prior controlled studies, including ~6% rates of hallucinations and infusion-site infections.
Trial readouts
Six-month interim results from ROSSINI (NCT06107426), an AbbVie-funded 10-country observational study of 427 adults, were published in Neurology and Therapy and represent the first prospective real-world readout for Vyalev; a 12-month interim analysis in 200 patients is planned next.
Other reader summaries (1)

Reader summary by xavier.grehant

by xavier.grehant on 2026-05-18

Pump therapies (LCIG, apomorphine) On/off fluctuations Dyskinesia Gait & freezing Pain Insomnia Levodopa formulations Trial readouts

Vyalev (also sold as Produodopa in Europe) is a therapy made by AbbVie that delivers levodopa and carbidopa — the standard Parkinson's medications — continuously under the skin via a small pump, 24 hours a day. Unlike oral pills, which cause levodopa levels in the blood to rise and fall with each dose, the pump keeps levels steadier. This matters because those peaks and troughs are what drive two of the most disabling problems in advanced Parkinson's: off episodes (periods when medication stops working and symptoms return, sometimes suddenly) and dyskinesia (involuntary, uncontrolled movements caused by too much levodopa at once).

The article reports six-month interim results from ROSSINI (NCT06107426), an ongoing real-world observational study following 427 adults with advanced Parkinson's across 10 countries in routine clinical care — not a tightly controlled lab trial, but an important first look at how the therapy performs in everyday practice. Among the 105 newly treated participants with evaluable data, daily off time dropped by an average of 2.8 hours (about 53%), and daily dyskinesia time fell by 1.8 hours (also roughly 53%). Standard motor scores improved significantly, freezing of gait lessened, and nonmotor symptoms — pain, sleep disturbances, and gut problems — also got better. Quality of life scores improved, especially in mobility, emotional well-being, and physical comfort. About a third of participants stopped treatment within six months, most commonly due to personal choice or side effects; hallucinations and skin infections at the infusion site each affected around 6% of patients.

For someone living with advanced Parkinson's who still experiences hours of daily off time despite optimised oral medication, this real-world data adds meaningful reassurance that Vyalev performs outside of clinical trials similarly to how it did inside them. It is already approved in the US and Europe, so this is a conversation you can have with your neurologist now — not a future hope. The key question to raise is whether your off-time burden justifies moving to a pump, and whether the practical demands (wearing a device 24/7, managing infusion-site care) are right for your situation. A 12-month interim analysis of 200 patients is planned next, which will give a clearer picture of longer-term tolerability.

What this article adds

Pump therapies (LCIG, apomorphine)
Six-month real-world data from the ROSSINI observational study (n=105 newly treated patients) show Vyalev (foslevodopa/foscarbidopa subcutaneous infusion) cut daily off time by ~53% and dyskinesia time by ~53% in advanced Parkinson's — the first prospective real-world evidence for this pump therapy since its recent approval.
On/off fluctuations
ROSSINI interim data show that 24-hour continuous subcutaneous Vyalev infusion reduced mean daily off time from ~5.2 hours to ~2.4 hours at six months in real-world advanced Parkinson's patients, supporting the clinical-trial efficacy signal in a routine-care setting.
Dyskinesia
In the ROSSINI real-world study, daily dyskinesia time fell by an average of 1.8 hours (53%) after six months on Vyalev, consistent with the smoother levodopa delivery reducing peak-dose involuntary movements outside of controlled trial conditions.
Gait & freezing
ROSSINI six-month data showed a significant reduction in freezing of gait among advanced Parkinson's patients on Vyalev, adding real-world evidence that continuous levodopa delivery may ease this particularly disabling motor symptom.
Pain
The ROSSINI study found that Vyalev significantly reduced pain scores in advanced Parkinson's patients after six months, one of the few real-world datasets to document a nonmotor benefit of continuous subcutaneous levodopa infusion on pain specifically.
Insomnia
ROSSINI interim results reported significant improvement in sleep disturbances after six months of 24-hour Vyalev infusion in advanced Parkinson's, suggesting that stabilising overnight levodopa levels may contribute to better sleep in this population.
Levodopa formulations
ROSSINI provides the first prospective real-world effectiveness data for foslevodopa/foscarbidopa (Vyalev) — a subcutaneous prodrug formulation — showing comparable efficacy to its Phase 3 trial results and a safety profile consistent with prior controlled studies, including ~6% rates of hallucinations and infusion-site infections.
Trial readouts
Six-month interim results from ROSSINI (NCT06107426), an AbbVie-funded 10-country observational study of 427 adults, were published in Neurology and Therapy and represent the first prospective real-world readout for Vyalev; a 12-month interim analysis in 200 patients is planned next.

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