Amneal Submits NDA for Parkinson’s Disease Therapy

Amneal Pharmaceuticals has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for IPX203, a novel, oral formulation of carbidopa/levodopa extended-release capsules for the treatment of Parkinson’s disease.

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.

Chintu Patel

“The RISE-PD data indicate IPX203 can offer patients a new and important treatment option that will enable them to have more ‘Good On’ time during the day, which we believe would be a significant new benefit for Parkinson’s patients. We are working with the FDA to bring this treatment to market, co-CEO Chintu Patel, said in a press release.

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. Extending “Good On” time and reducing “Off” time are often key goals for patients, caregivers and healthcare providers as this can provide more consistent symptom control throughout the day.

Carbidopa/levodopa has been the gold standard of treatment for Parkinson’s disease since the 1970s, but additional options are needed that can help patients function more consistently with an increase in “Good On” time per dose. Based on data in the Amneal clinical trials, IPX203 can offer patients additional “Good On” time with reduced dose frequency compared to immediate-release Parkinson’s disease.

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. IPX203 is a novel, oral formulation that 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.