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FDA Reviewing Four New Parkinson's Medications in 2024

Getting Precise about Precision Medicine in Parkinson's

There’s a lot of promise and momentum in Parkinson’s drug development. We started 2024 with the potential for four new Parkinson’s medications to gain approval in the United States. These treatments include the following:  

  • Under-the skin, continuous apomorphine infusion, given through a pump, like an insulin pump used by people with Diabetes Mellitus Type 2 

  • Under-the-skin, continuous levodopa/carbidopa infusion, also given through an insulin pump-like device 

  • Under-the skin, continuous levodopa/carbidopa infusion given through a pump-patch that attaches to the skin  

  • Reformulated, potentially longer-acting levodopa/carbidopa pill  

New Therapies Aim for Better Parkinson’s Symptom Control 

All these medications temporarily replace or mimic dopamine, the brain chemical that decreases in Parkinson’s, causing movement difficulties. The infusions aim to provide a consistent medication level to help smooth out symptom fluctuations — when times of little or no symptoms alternate with times of significant symptoms and/or extra movement (dyskinesia) throughout the day. The pill aims to potentially provide better symptom control with fewer daily medication doses.  

Approved

In August 2024, the FDA approved the reformulated, longer-acting levodopa/carbidopa pill, now called Crexont. It becomes the 19th new treatment approved in the last decade.

Updates on Potential Approvals 

Each of the new device-based drug’s applications received a “complete response letter” (CRL) from the FDA. These letters outlined areas for drugmakers to address about the devices themselves or the manufacturing process. While this is a delay in the approval process, the good news is that each of these medications could still gain approval. The drugmakers are working with the FDA to address outstanding matters and potentially resubmit their application.  

In August 2024, Supernus Pharmaceuticals announced it had resubmitted its application for the continuous apomorphine infusion.

Learn more about how the FDA approval process works and view our full breakdowns of currently available Parkinson’s medications. And stay tuned to our channels for the latest research and drug development news. 

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