At the American Academy of Neurology (AAN) 2024 Annual Meeting, Amneal Pharmaceuticals presented new safety data for IPX203 (carbidopa + levodopa, CD/LD) from its Phase III clinical trial RISE-PD and open-label extension in Parkinson’s disease (PD) patients with motor fluctuations.
The poster presentation demonstrated the safety profile of IPX203 and its potential to offer an additional treatment option to control motor fluctuations in patients with PD.
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Levodopa has been the standard of care (SOC) for the symptomatic treatment of PD for the past five decades.
In the early stages of the disease, motor symptoms are well managed by levodopa, but as the disease progresses, reliable dosing becomes more difficult.
The progressive degeneration of the dopaminergic neurons narrows the window of optimal levodopa plasma concentration, causing motor fluctuations to emerge.
Peaks and troughs in levodopa plasma concentration are responsible for peak-dose dyskinesia and off-episodes, respectively, two of the most common motor complications.
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By GlobalDataKey opinion leaders (KOLs) previously interviewed by leading data and analytics company GlobalData stated that 33% of PD patients experience dyskinesia and almost all of them will eventually have off-episodes.
As such, oral extended-release (ER) formulations such as Amneal’s Rytary (CD/LD) are often prescribed to moderate and advanced-stage PD patients over immediate-release (IR) formulations.
Rytary received US Food and Drug Administration (FDA) approval in 2015 and will see its US patent expire in 2028.
IPX203 is an ER formulation that consists of a combination of IR CD/LD granules and ER beads of levodopa, a formulation that is distinct to Rytary.
In the RISE-PD study, there was a statistically significant improvement in efficacy for IPX203 compared to the immediate-release CD/LD, achieving the study’s primary endpoint.
IPX203 treatment resulted in 0.53 more hours of ‘Good On’ time than IR CD/LD when comparing change from baseline in both study arms.
‘Good On’ time is defined as the total time with either non-troublesome dyskinesia symptoms or duration without dyskinesia.
However, KOLs previously interviewed by GlobalData indicated that the improvement in efficacy with IPX203 compared with IR CD/LD was not significant to impact their treatment patterns, especially if IPX203 is anticipated to have premium pricing.
However, IPX203 would offer an alternative treatment option for patients, particularly those who have not had a good experience with Rytary.
Amneal’s AAN 2024 poster presentation reported the safety profile of IPX203 by modal dose range and duration of exposure.
In the study, 179 patients were exposed to IPX203 continuously for at least 12 months.
During the study, patients received a wide distribution of doses to achieve the desired clinical response, with the dose that patients took most frequently (modal doses) ranging from 140mg/560mg CD/LD to 1,260mg/5,040mg CD/LD a day.
The occurrences of treatment-emergent adverse events (TEAEs) were similar across the different modal doses and the number of patients with serious TEAEs was low in all modal dose ranges.
The majority of TEAEs occurred within the first three months of drug treatment. In addition, as the exposure time with IPX203 increased, there was a decrease in the number of TEAEs.
This was consistent across the different modal dose ranges, suggesting that IPX203 is safe and well-tolerated across a wide distribution of doses in PD patients with motor fluctuations.
In July 2023, Amneal received a Complete Response Letter from the FDA.
While the new drug application for IPX203 supported the safety of levodopa, the FDA stated that to proceed, additional safety data was required for the carbidopa component of IPX203.
In February 2024, Amneal presented its Complete Response Resubmission to the FDA, which included additional pharmacokinetic data from a healthy volunteer study.
Should IPX203 receive FDA approval, IPX203 will help Amneal secure a strong position in the future PD market, which is important given the anticipated loss of patent protection for Rytary.
