IPX203 FDA Approval Status
Last updated by Judith Stewart, BPharm on July 4, 2023.
IPX203 (carbidopa/levodopa) is a novel, oral formulation of carbidopa/levodopa (CD/LD) in development for the treatment of Parkinson’s disease (PD).
- Many people living with PD experience motor fluctuations as part of their symptoms. "On" time refers to periods when these symptoms are better controlled, and patients can move and function better. Extending "Good On" time and reducing "Off" time are often key goals for patients, caregivers and healthcare providers as this can provide more consistent symptom control throughout the day.
- IPX203 contains immediate-release (IR) granules and extended-release (ER) coated beads. The IR granules consist of carbidopa and levodopa, with a disintegrant polymer to allow for rapid dissolution. The ER beads consist of levodopa, 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 beads from disintegrating prematurely in the stomach.
- The NDA submission for IPX203 is based on results from the pivotal Phase 3 RISE-PD clinical trial demonstrating more "Good On" time compared to immediate-release CD/LD. The trial also showed that subjects on IPX203 demonstrated significantly less "Off" time compared with immediate-release CD/LD. A post-hoc analysis of the Least Squares Mean difference at end of study (week 20) showed that IPX203 provided 1.55 more hours of “Good On” time per dose versus immediate-release CD/LD, representing a 70% per dose increase.
- On July 3, 2023, Amneal Pharmaceuticals, Inc. announced that it had 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.
Development timeline for IPX203
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