Amneal Pharmaceuticals has recently announced that its pipeline product IPX-203 (carbidopa + levodopa, (CD/LD)) achieved key primary and secondary endpoints in the pivotal Phase III RISE-PD clinical trial for patients with Parkinson’s disease (PD) who experience motor fluctuations. Levodopa’s short half-life makes dosing difficult to manage and the treatment is often associated with dyskinesia and the medicine’s wearing-off episodes. The market for new products aimed at controlling motor fluctuations holds great potential, says GlobalData, a leading data and analytics company.

Christie Wong, Pharma Analyst at GlobalData, comments: “Levodopa has been the gold standard of care for patients with PD for over 50 years. However, the decline in efficacy of levodopa and the emergence of motor fluctuations after a few years of its use remains a major challenge for physicians and patients”

Amneal’s IPX-203 has an innovative controlled-release delivery technology whereby the CD/LD combination is delivered orally in a gastric-retentive capsule that prolongs the absorption of levodopa. The RISE-PD clinical trial demonstrated a statistically significant improvement in efficacy for IPX-203 compared to immediate-release CD/LD, as measured by the total time with non-troublesome dyskinesia symptoms or without dyskinesia and the duration of off-episodes. Amneal plans to submit a New Drug Application (NDA) for IPX-203 with the US Food and Drug Administration (FDA) in mid-2022. GlobalData forecasts that IPX-203 will generate global sales of $118m by 2029.

Wong adds: “IPX-203 is likely to compete with Intec’s Accordion Pill, a CD/LD combination, which is also in Phase III development. However, Key Opinion Leaders (KOLs) interviewed by GlobalData reported that IPX-203 and the Accordion Pill are expected to be a slight improvement on Amneal’s Rytary, an extended-release CD/LD treatment that was approved in 2015. As such, some KOLs believed that IPX-203 and the Accordion Pill would not have a big impact on their treatment algorithm if they were approved.

“Furthermore, novel levodopa delivery systems in Phase III development, namely AbbVie’s ABBV-951 and Mitsubishi/NeuroDerm’s ND-0612 are pipeline candidates that could be alternatives to the oral formulations. The two products can be continuously administrated at a fixed dose over a 24-hour period, via subcutaneous infusions. If approved, they are expected to capture a patient share from the oral levodopa formulations.”