Commentary
Video
Properly Integrating Newly Approved IPX203 in the Care of Parkinson Disease
The panelists provided clinical insight on the utilization of IPX203, its potential benefits and clinical implications, as well as the practicalities of transitioning patients from other therapies.
Earlier this month, the FDA approved Amneal Pharmaceuticals’ investigational agent IPX203, an oral formulation of carbidopa/levodopa (CD/LD) extended-release capsules, as a treatment for patients with Parkinson disease (PD). Marketed as Crexont, the therapy is an oral formulation CD/LD which includes immediate-release granules as well as extended-release pellets. In its announcement, Amneal noted it expects the oral treatment to be available to patients in the United States in September 2024.
Amneal’s CD/LD ER capsule product was approved based on data from the phase 3 RISE-PD clinical trial (NCT0300788), a double-blind study published in JAMA Neurology in August 2023. In the study, those treated with IPX203 at least 3 times per day (n = 256) showed a statistically significant improvement of 0.53 hours (95% CI, 0.09-0.97; P = .02) in daily good ON time relative to those on IR CD/LD (n = 250), who were dosed 5 times per day.
Following the approval, NeurologyLive® assembled a panel of movement disorder experts to discuss the downstream impacts of IPX203 as a new treatment for patients with PD. The panelists include Robert Hauser, MD, a professor of neurology at the University of South Florida and director of the Parkinson’s Disease and Movement Disorder Center, and Hubert Fernandez, MD, a neurologist and director of the Center for Neurological Restoration at the Cleveland Clinic.
In this episode, the pair of neurologists detailed some of the next steps of incorporating IPX203 into clinical care following its approval. They described how IPX203 might be initially used and in the long-term, considering its potential to be prescribed earlier in the treatment process. In addition, the duo speculated on the future research directions, particularly comparing the continuous delivery of levodopa through subcutaneous infusions with oral administration like IPX203, and its potential to reduce dyskinesia. Furthermore, the panel touched on the practicalities of transitioning patients to IPX203, including payer support and the initial patient profiles most likely to benefit from this medication.
Transcript edited below for clarity.
Robert Hauser, MD: So, how do you anticipate the medication being used now?
Hubert Fernandez, MD: Well, it depends on a lot of factors. Probably the biggest factor is whether we're allowed to actually prescribe it and whether payers would support such a prescription. Assuming that we would reasonably be able to use it, then I think, initially, its use would be by the book, for patients who are experiencing significant off periods during the day, despite being on medication four or five or more times per day of immediate-release levodopa, likely with at least one more medication to justify the conversion and the exercise. But I predict that as we get more accustomed to the medication and become more comfortable with IPX203, then the needle might really move to an earlier point. When you have a medication, for example, that is known to be the best we have, with a better and more optimal delivery of that medication, why save it until the very end or the middle of that journey? Maybe we could use it a lot earlier, at the first sign of motor fluctuation or off periods, and not necessarily reserve it for someone who’s taking levodopa five, six, or seven times a day, with one or two add-on medications and still suffering from that.
Robert Hauser, MD: Yeah, that's right. So, I think it should be considered for just about any patient who's experiencing motor fluctuations with off episodes. I think there will be interest in the future regarding whether starting it early—maybe even right from the beginning—could delay or avoid future motor complications, including off periods and dyskinesia. That's speculative and an area of research. And what about patients who have off time and dyskinesia? There's a lot of interest coming from the field of subcutaneous infusions that provide continuous levodopa through the day and night. Those patients seem to get less dyskinesia over time. Could we achieve that with an oral medication like IPX203? Again, this is speculation and an area of research, but for now, this looks like a potentially helpful medication for just about all patients who have fluctuations and off periods. So with that, Hubert, I'm going to say thank you very much. I think we covered this pretty well, and hopefully, this has been helpful to our audience. So, thank you, everyone.
