Amneal Receives U.S. FDA Complete Response Letter for IPX203

Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Company’s New Drug Application (NDA) for IPX203 for the treatment of Parkinson’s disease.

The letter indicated that although an adequate scientific bridge was established for the safety of one ingredient, levodopa (LD), based on pharmacokinetic studies, it was not adequately established for the other ingredient, carbidopa (CD), and FDA has requested additional information. The letter did not identify any issues with respect to the efficacy or manufacturing of IPX203. Amneal will work closely with the FDA to address its comments and plans to meet with the agency to align on the best path forward.

“We are committed to advancing IPX203 for Parkinson’s disease, which has been developed to provide a longer duration of therapeutic benefit than existing formulations with fewer doses,” said Chirag and Chintu Patel, Co-Chief Executive Officers at Amneal. “We plan to work closely with the FDA to address the agency’s feedback and we remain confident in bringing this new treatment to Parkinson’s patients as soon as possible.”

The NDA submission is based on the results from the Phase 3 RISE-PD clinical trial, which found that IPX203’s extended-release formulation offers significantly more “Good On” time, as well as significantly less “Off” time, compared to immediate-release CD/LD, even when dosed less frequently.

This does not impact Amneal’s 2023 financial guidance, which did not include IPX203 revenues.

About IPX203
IPX203 is a novel, oral formulation of CD/LD extended-release capsules designed for the treatment of Parkinson’s disease. IPX203 contains immediate-release granules and extended-release coated beads. The IR granules consist of CD and LD, with a disintegrant polymer to allow for rapid dissolution. The ER beads consist of LD, coated with a sustained release polymer to allow for slow release of the drug a mucoadhesive polymer to keep the granules adhered to the area of absorption longer, and an enteric coating to prevent the granules from disintegrating prematurely in the stomach. This formulation is distinct from RYTARY (carbidopa/levodopa) extended-release capsules, Amneal’s extended-release CD/LD treatment for PD approved by the U.S. FDA in 2015.