IPX203 shows sustained safety, efficacy in RISE-PD extension trial

[Farooqji]

Using IPX203, an extended-release formulation of carbidopa/levodopa (CD/LD), was associated with a sustained control of symptoms for Parkinson’s disease patients who participated in the open-label extension of the RISE-PD Phase 3 trial.

Final results from the nine-month extension study (NCT03877510) indicate dose adjustments and side effects were most common in the first months of treatment, and tended to stabilize after that. The study, “Safety and Efficacy of IPX203 in Parkinson’s Disease: The RISE-PD Open-Label Extension Study,” was published as a brief report in Movement Disorders. It was sponsored byIPX203’s developer, Amneal Pharmaceuticals.

CD/LD is a standard combination for treating Parkinson’s. Levodopa is a precursor to dopamine, the brain signaling chemical that’s lost in the neurodegenerative disease. Carbidopa helps prevent levodopa’s conversion to dopamine in the bloodstream, enabling more to reach the brain where it’s needed.

IPX203 is an extended-release formulation of this treatment duo that contains immediate-release granules of CD/LD as well as extended-release coated beads of levodopa.

The aim is to enable the medication to stay at clinically relevant doses in the bloodstream longer, extending motor symptom control relative to standard, immediate-release CD/LD therapies such as Sinemet. This could also help prevent off episodes, or motor fluctuations — periods when symptoms return between levodopa doses — and increase on episodes, when symptoms are well controlled without troublesome involuntary movements, called dyskinesia.

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[Nuthatcher]

Thanks for posting this. I was in the original study and have been trying to follow it

[Jana86]

We already have Rytary for extended release of C/L. How does this formulation differ or compare?

[Nuthatcher in reply to Jana86]

I was a part of the study and felt more normal on this drug than I have since before PD. Since it hasn’t been approved by the FDA yet my doctor prescribed Rytary for me saying that Rytary is IPX203’s great grandfather. Virtually no off time. No dyskinesia. I really hope that the FDA approves it and that I will be able to afford it (LOL)

[Farooqji in reply to Nuthatcher]

Thanks for sharing

[Farooqji]

updates:

Knight gains rights to IPX203, for off times, in Canada and Latin America

parkinsonsnewstoday.com/new...