FDA Needs More Data on Novel Carbidopa/Levodopa Formulation; Issues CRL

The Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Amneal Pharmaceuticals regarding the New Drug Application (NDA) for IPX203 for the treatment of Parkinson disease.

IPX203 is a novel, oral capsule formulation that contains immediate-release (IR) granules of carbidopa and levodopa and extended-release beads of levodopa. The application included data from the phase 3 RISE-PD trial (ClinicalTrials.gov Identifier: NCT03670953), which compared the efficacy and safety of IPX203 to carbidopa/levodopa (CD/LD) IR in Parkinson disease patients with motor fluctuations. Treatment with IPX203 was associated with a statistically significant improvement in “Good On” time and with significantly less “Off” time compared with CD/LD IR.

According to the letter, the product could not be approved based on the data provided as additional information was needed on the safety of the carbidopa component. The pharmacokinetic studies had only established the safety of one ingredient, levodopa.

“We are committed to advancing IPX203 for Parkinson 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 patients as soon as possible.”

The Agency did not identify any issues related to clinical efficacy or manufacturing.

This article originally appeared on MPR