Pharma Focus Asia

Amneal Submits Revised Application for IPX203 New Drug Approval

Friday, February 09, 2024

Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) has announced its submission of a Complete Response resubmission to the U.S. Food and Drug Administration (FDA) for IPX203, an innovative oral formulation of carbidopa/levodopa (CD/LD) extended-release capsules aimed at treating Parkinson’s disease (PD).

The initial New Drug Application (NDA) for IPX203 resulted in a Complete Response Letter (CRL) from the FDA. In response, the resubmission package includes data from a study conducted with healthy volunteers in the fourth quarter of 2023. Notably, the FDA did not request any additional studies.

"We are pleased to present our complete response resubmission for IPX203 as part of our efforts to expand our Parkinson’s franchise," stated Chirag and Chintu Patel, Co-Chief Executive Officers at Amneal. "We anticipate launching this much-needed treatment in the second half of 2024, pending FDA approval."

IPX203 is an oral formulation of CD/LD extended-release capsules specifically developed for the treatment of Parkinson’s disease. It comprises immediate-release granules and extended-release coated beads. The immediate-release granules contain CD and LD along with a disintegrant polymer for rapid dissolution. Meanwhile, the extended-release beads consist of LD coated with a sustained-release polymer to facilitate slow drug release, a mucoadhesive polymer for prolonged adherence to the absorption area, and an enteric coating to prevent premature disintegration in the stomach. This formulation differs from RYTARY® (carbidopa/levodopa) extended-release capsules, another extended-release CD/LD treatment for PD approved by the U.S. FDA in 2015.

Parkinson’s disease is the fastest-growing neurological disorder worldwide, with approximately 1 million patients diagnosed in the U.S. It is a progressive disorder of the central nervous system (CNS) affecting dopamine-producing neurons in the brain, which control movement.

PD is characterized by symptoms such as slow movement, stiffness, resting tremor, and impaired balance. While PD is not classified as a fatal disease, it is associated with significant morbidity and disability. The average age at diagnosis is 60, and as life expectancy increases, the number of PD patients is expected to rise substantially in the coming decades.



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