Editor’s note (February 12, 2024): Amneal has resubmitted its drug application to the FDA for review, and hopes for a final decision regarding approval by the second half of 2024.
Editor’s note (July 17, 2023): Amneal, the maker of IPX203, recently announced receipt of a complete response letter from the FDA. In the letter, the agency requested additional information on the safety of one of the drug’s ingredients, carbidopa. There were no questions on the drug’s efficacy or manufacturing. Amneal will now work with the FDA to address concerns and resubmit their application for potential approval.
Researchers and drug developers are consistently looking for ways to better treat Parkinson’s. One path toward better treatment aims to improve existing medications, like levodopa. Levodopa works well, especially early in disease. But over time, it can feel less effective or contribute to involuntary movement (dyskinesia). (Read more about levodopa.)
A new formulation of levodopa recently went to the FDA for potential approval. Amneal Pharmaceuticals’ IPX203 is a pill containing both immediate- and extended-release levodopa and carbidopa. This combination is similar to the currently available brand-name Rytary. But IPX203 has been reformulated for potentially better absorption and longer lasting effects. It may be able to control Parkinson’s motor symptoms (tremor, slowness, stiffness) for longer periods of time and with fewer doses each day.
A Phase III clinical trial compared IPX203 to immediate-release levodopa/carbidopa in people with Parkinson’s disease who have good symptom control alternating with poor symptom control (motor fluctuations) and/or dyskinesia. When taking IPX203, volunteers had one-half hour more time without symptoms (“on” time) and without dyskinesia than they had on immediate-release levodopa/carbidopa. IPX203 was dosed, on average, three times per day; immediate-release levodopa/carbidopa was taken, on average, five times per day. Studies did not directly compare IPX203 to Rytary. (Read more about Rytary.)
The FDA has up to 10 months to decide on approval. If this medication is approved, it may offer another treatment option for people who experience fluctuating control of symptoms throughout the day, potentially with fewer total daily doses.
