FDA to Evaluate IPX203 for the Treatment of Parkinson Disease

The FDA will review a New Drug Application (NDA) for IPX203 for the treatment of Parkinson disease (PD).

IPX203 is a novel, oral formulation of carbidopa/levodopa (CD/LD) extended-release capsules. The drug is comprised of immediate-release (IR) granules and extended-release (ER) beads.

IR granules are comprised of CD and LD plus a disintegrant polymer to allow for rapid dissolution. ER beads consist of LD coated with a sustained release polymer to facilitate slow release of the drug, a mucoadhesive polymer to adhere the granules to the area of absorption for a longer period of time, and an enteric coating to stop the granules from premature disintegration in the stomach.

The formulation is distinct from carbidopa/levodopa (Rytary, Amneal) extended-release capsules, which is Amneal’s extended-release CD/LD treatment for PD approved by the FDA in 2015.

“The FDA filing acceptance of IPX203 marks another important milestone for Amneal as we strive to improve the lives and care of people living with Parkinson’s disease,” said Gustavo Pesquin, chief commercial officer, Amneal Specialty, in a press release. “We look forward to engaging in conversations with the FDA as we advance the application. We believe the data in our RISE-PD study supports the important benefit IPX203 can offer to this community by providing longer duration of symptom control with the benefit of fewer doses.”

The NDA was based on data from the multicenter, double-blind, parallel-group RISE-PD trial, which evaluated the efficacy and safety of IPX203 CD/LD extended-release capsules vs immediate-release CD/LD in the treatment of patients with PD who have motor fluctuations.

The trial was comprised of a 3-week, open-label immediate-release CD/LD dose adjustment period and a 4-week, open-label period for conversion to IPX203. Following this was a 13-week double-blind treatment period in which patients were randomized 1:1 to receive either IPX203 or immediate-release CD/LD.

The baseline for all endpoints was week 7, with nausea being the most common adverse event and greater than immediate-release CD/LD.

The primary endpoint of the trial assessed the change from baseline in “good on” time in hours per day at the end of the double-blind treatment period, which is defined as the sum of “on” time without dyskinesia and “on” time with non-troublesome dyskinesia.

The secondary endpoints evaluated the change from baseline in “off” time in hours per day, proportion of patients who were either “much improved” or “very much improved” in Patients’ Global Impression of Change (PGI-C) scores, change from baseline in the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part 3 score.

REFERENCE

Amneal Announces U.S. FDA Filing Acceptance of New Drug Application for IPX203 for the Treatment of Parkinson’s Disease. Amneal. November 11, 2022. Accessed November 15, 2022. https://investors.amneal.com/news/press-releases/press-release-details/2022/Amneal-Announces-U.S.-FDA-Filing-Acceptance-of-New-Drug-Application-for-IPX203-for-the-Treatment-of-Parkinsons-Disease/default.aspx