For Parkinson Therapy IPX203, Amneal has announced the complete response resubmission.

Published Date: 11 Feb 2024

Results from the phase 3 RISE-PD trial, in which treated patients demonstrated greater ON time than immediate-release CD/LD, supported the new drug application for IPX203, a novel oral formulation of carbidopa/levodopa.

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New 12-month interim data showed functional gains with BBP-418 vs placebo, consistent benefit across genotype, age, and baseline pulmonary function subgroups, and a safety profile comparable to placebo.

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