FDA Strikes Out Amneal Pharmaceuticals' Parkinson's Disease Candidate, Stock Falls

Amneal Pharmaceuticals Inc AMRX received an FDA Complete Response Letter (CRL) regarding its New Drug Application for IPX203 for 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).

The FDA has requested additional information. 

The letter did not identify any issues with the efficacy or manufacturing of IPX203.

Also Read: Amneal Pharma Q1 Exceeds Consensus View On Strength In Complex Generics Portfolio.

The submission was based on the results from the Phase 3 RISE-PD 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.

The company said the update does not impact Amneal's 2023 financial guidance, which did not include IPX203 revenues.

Price Action: AMRX shares are down 13.1% at $3.65 premarket on the last check Wednesday.