Amneal Receives Complete Response Letter on the NDA for IPX203 to Treat Parkinson’s Disease
Shots:
- The US FDA granted a CRL for the NDA of IPX203, an oral formulation of carbidopa/levodopa (CD/LD) extended-release capsules to treat Parkinson’s disease
- There were no issues identified with the clinical efficacy and manufacturing of IPX203. The PK data for the safety of one ingredient, levodopa, was sufficient & an additional data was needed for the second ingredient, carbidopa while the company will work with the US FDA to address its concerns
- The NDA submission was based on the P-III trial (RISE-PD) showed that IPX203’s extended-release formulation offers more “Good On” time, as well as significantly less “Off” time over immediate-release CD/LD even when dosed less frequently
Ref: Amneal | Image: Amneal
Related News:- Amneal Receives NDA Approval from the US FDA for Pemrydi RTU
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
