FDA Accepts NDA for Novel Parkinson’s Disease Therapy

IPX203 is an oral formulation of carbidopa/levodopa extended-release capsules that, if approved, could provide patients with better symptom control. The FDA assigned a Prescription Drug User Fee Act date of June 30, 2023.

The FDA has accepted for review Amneal Pharmaceuticals’ new drug application (NDA) for IPX203 to treat Parkinson’s disease (PD). The FDA assigned a Prescription Drug User Fee Act (PDUFA) date of June 30, 2023. IPX203 is a novel, oral formulation of carbidopa/levodopa (CD/LD) extended-release capsules.

“Amneal aims to provide people living with Parkinson’s disease effective treatments that allow them to live their lives with less concern about their mobility and symptoms, and more freedom to choose how to spend their time,” Gustavo Pesquin, chief commercial officer, Amneal Specialty, said in a press release. “We are pleased that IPX203 has the potential to address this need by extending periods when symptoms are better controlled, with less frequent dosing.”

The submission is based on results from the pivotal phase 3 RISE-PD clinical trial demonstrating more “Good On” time compared with immediate-release carbidopa/levodopa. The trial also showed this was the case when IPX203 was dosed on average three times per day and immediate-release carbidopa/levodopa was dosed on average five times per day. The trial also showed that subjects on IPX203 demonstrated significantly less “Off” time compared with immediate-release carbidopa/levodopa.

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. Carbidopa/levodopa has been used since the 1970s.

Amneal’s therapy contains extended-release beads that consist of levodopa, coated with a sustained release polymer, to allow for slow release of the drug. Additionally, this formulation contains immediate-release granules that consist of carbidopa and levodopa, with a disintegrant polymer to allow for rapid dissolution. This formulation is distinct from Rytary extended-release capsules, Amneal’s extended-release carbidopa/levodopa treatment for Parkinson’s disease approved by the FDA in 2015.

Related: Amneal Submits NDA for Parkinson’s Disease Therapy

The NDA was submitted in September 2022.