EAN 2026 | Guidance for clinicians on the real-world use of foslevodopa/foscarbidopa for PD

Yeah, it’s quite a long sort of remit to answer. I think the first thing to remember is that foslevodopa/foscarbidopa infusion is currently the only subcutaneous infusion that is available, which uses levodopa and carbidopa, which is the gold standard of our treatment. But the great thing about this is the use of a small pump and the ability to deliver this for 24 hours. We don’t have anything that is 24 hours apart from perhaps deep brain stimulation, which can be continued for 24 hours. Some people would say, well, you can continue, you can even give apomorphine or levodopa in duodenal for 24 hours, but that needs extra dosing, extra time, etc. So 24 hours therapy is really quite unique to foslevodopa/foscarbidopa. This has advantages. The advantages clearly are those of continuous dopaminergic stimulation, which is thought to be a physiological way of delivering dopamine in Parkinson’s, supported by an absolute wealth of animal model and basic science data. But also, importantly, it also addresses some of the nighttime issues in Parkinson’s, which are so critical for sleep in Parkinson’s. Issues such as nocturnal movement problems are helped by the infusion, particularly in early morning when patients are severely off, can’t turn in bed, may wake up with severe pain, dystonia, etc., or are getting up at night to pass urine, nocturia, or have significant restless legs or leg movements like PLM. We now know that these features can be severely disruptive to sleep. And sleep disruption is one of the singular causes of our glymphatic system in the brain not being refreshed, which has been linked with high rates of dementia. So the therapy, therefore, is providing you daytime benefit, as is well shown in a lot of clinical trial data, but also with real-world data that’s come out very recently. And secondly, it is also supporting nighttime benefit, which normal therapies don’t. And often sleep therapy is neglected. So in one therapy, you’re addressing both.

The issue that has risen recently are twofold. One is that the therapy can lead to skin issues. And we know that pretty well. Rates can be as high as 30 to 35%. But really, now that we have much experience with this therapy, it leads to discontinuation. If you’ve got very good skin hygiene, if you follow some simple rules that the liquid doesn’t drip onto the skin or you’re taking care of the skin in a very regular way. Skin hygiene is important. And your patient selection is important. For instance, if somebody’s low body weight with history of diabetes, for instance, which causes the skin to become quite problematic in some cases, you have to be very careful in such people with the skin therapy. So therein comes the patient selection. And we’ve written a big consensus paper on it, which has been published in Movement Disorders Clinical Practice. And I would signpost all people who use foslevodopa/foscarbidopa. They must, must look at this paper because it addresses those issues very closely. Second is a growing concern by some people, not all, that apparently this nighttime infusion alters our circadian rhythm, the sleep-wake cycle, and can paradoxically lead to emergence of psychosis. I and many others don’t agree with that, and we’ve just written a review paper on it showing, yes, psychosis is a risk factor, but with certain precautions, you can actually either very successfully manage it and it should not be a deterrent to using this drug. And this is where, again, patient selection comes in to the fore. You have to be very careful in older, frail, vulnerable patients who might have high frailty index, who might have had psychosis with oral dopamine agonist therapies, who might be having cognitive issues, particularly dementia, because in some of the studies which show very high rates of dementia, sorry, high rates of psychosis, if you go back to the patients, you’ll see either they’re very frail and old, they’ve failed all other therapies, they’ve had history of psychosis with the use of dopamine agonists, for instance, and they might be on concurrent medication when foslevodopa/foscarbidopa started. So you need to avoid all these things. And there have been some very good, you know, references and guidelines, or not guidelines, but recommendations that have been proposed by Antonini and Bergman, for instance, but also in our recent review, which is due to come out soon. So I think, and in some cases, if you do get the psychosis, etc., you may even have to stop the nighttime dose for a few days, and then gradually reintroduce it. And we have done that in clinical cases. In many such patients, the psychosis resolves, and you can continue with the therapy. So I think those are the two main things that people who are starting this therapy need to be aware of.

But the benefits are absolutely, you know, superb. In many younger patients, it actually gives them back years of their life, which other drugs would struggle to do unless you do DBS. And it being a very small pump, you know, it doesn’t really address so much of your body image, particularly for a younger woman with Parkinson’s. You can hide the pump in your jacket and so on. And just being very careful with the insertion, I think it works very well. From a practical point of view, again, when you’re choosing patients, it’s really quite important to also ask about their nighttime abilities. If you find by history-taking that the patient’s having significant early morning off, or they are having difficulty turning in bed with frequent wakenings, or they have severe PLM, which is periodic limb movements, at night waking. Or they have early morning off related pain and dystonia. This drug is very, very good to address those along with the daytime problems that you have. So I think all in all, it’s a plus. But with those caveats of skin issues and psychosis, I think people who are using and starting these drugs need to be aware of those things so that they can manage it successfully. And now we have the recommendations, the Movement Disorders Clinical Practice recommendation, which I think should be mandatory to all people going on, foslevodopa/foscarbidopa clinicians and nurse specialists who are going to be using this drug. And secondly, the review on psychosis, which is due out soon.

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