AAN 2025 | The infusON trial: continuous, subcutaneous apomorphine for PD motor fluctuations

We’re always trying to get better therapies for our patients both early in the disease, looking at novel mechanisms as the disease progresses for later disease, and we’re also looking for therapies that may have already existed and that help people. And one of these therapies, a subcutaneous infusion of apomorphine, has been widely available globally in Europe, in Asia and Australia for over 30 years and just recently was approved by the FDA for treating off fluctuations in people with Parkinson’s disease. So we’re really happy that we now have this therapy that we can offer for patients who have advanced Parkinson’s disease and these off fluctuations using a device to infuse apomorphine continuously over the waking day, just beneath the skin where it’s absorbed into the circulation as a direct agonist at the dopamine D1 and D2 family receptors can improve motor and perhaps non-motor aspects of the disease. But we want to get some experience in the U.S. because we didn’t have it here and our colleagues and friends throughout Europe and and elsewhere in the world we’ve had great learnings from them we’ve been able to hear from their patient experiences but we need experience in the U.S. So we set up a USS study to really evaluate the efficacy, safety, and tolerability of giving subcutaneous apomorphine by this device. And this study went on for a number of years because it was designed as an open-label safety study with predetermined efficacy endpoints put in this as well. The study infusON has recently been published and then we’re able to demonstrate that similar to what was seen in the TOLEDO double-blind randomized placebo-controlled trial performed in Europe at expert centers with experience using subcutaneous apomorphine infusion in the U.S. in our open-label safety study, we saw very, very similar efficacy improvement beginning early on within a week or so in improving off time, in improving good on time. And then we saw that durability of benefit at 12 weeks and at 52 weeks. And the study is ongoing and there’ll be further reports looking long term. We also demonstrated similar safety and tolerability of using the apomorphine infusion. Skin reactions can occur. These are typically sterile inflammation. How the body’s immune surveillance activates immune cell inflammatory cells to remove any residual apomorphine that resides beneath the dermis, where the apomorphine is absorbed typically once the device is taken off. So these inflammatory cells can sometimes be felt beneath the skin as a nodule. Sometimes the inflammation can increase over a day or two. You might see some redness on the skin. And we were able to present at the Academy of Neurology as well some information on these skin reactions and how to handle them. If they’re mild or moderate, they typically resolve by themselves in a day or two. If the redness may increase over several days, we can watch that as inflammation. If they seem to be more increasing over time and there’s any concern of infection, we wouldn’t expect. And we didn’t see infections in the U.S. safety study or in the TOLEDO double blind study. But if we do think there could be infection, we can use an empiric antibiotic, of course, if there’s anything to culture. But empiric antibiotic often we can use as well. So I can typically at our clinics, we tend to use doxycycline, 100 milligrams BID for seven days. So we give our patients this type of information. So I think we have a lot of learnings from Europe and globally of using apomorphine over the past several decades. Now in the U.S., I think we can be assured that in using apomorphine through this device, but just beneath the skin with this teflon catheter that’s about nine millimeters, just goes right through the dermis and infusing it over the 16 hours. You take it off overnight. It can be started at home, can be gradually increased, and patients will have, I think, predictable improvements in their motor and non-motor symptoms, less fluctuations and durability of benefit and demonstrated tolerability, similar to what has been seen over the decades in expert centers throughout the world.

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