Today the U.S. Food and Drug Administration announced the approval of Vyalev, the first and only subcutaneous infusion of levodopa that has been shown to increase “on” time without dyskinesia in people with Parkinson’s disease. “On” time refers to the period of time when medications are working well and symptoms are controlled. A Phase 3 study of Vyalev showed that the treatment improves “on” time by almost three hours per day compared to oral levodopa/carbidopa.

In a press release from AbbVie, Robert A. Hauser, M.D., MBA, Professor of Neurology and Director of the Parkinson’s and Movement Disorder Center at the University of South Florida said, “For too long, the Parkinson’s community has had limited treatment options for advanced disease. Due to the progressive nature of the disease, oral medications are eventually no longer as effective at motor symptom control and surgical treatment may be required. This new, non-surgical regimen provides continuous delivery of levodopa morning, day and night.”

If you’re experiencing “off” time, dyskinesias, or feeling that your medications aren’t adequately controlling your symptoms, it’s worth a discussion with your healthcare provider to determine if Vyalev might be a good option for you. Timing for a patient’s access to Vyalev is dependent on their individual insurance plan. Coverage for Medicare patients is expected in the second half of 2025.

For more information, visit the AbbVie News Center.

When Parkinson’s medications are working and symptoms are controlled – also known as “On” time – people with the disease feel better and are more able to participate in the activities they enjoy. So when the FDA approves a new drug that extends “Good On” time for people with Parkinson’s, it’s encouraging news for our community.

This week, the FDA approved CREXONT®, a drug developed by Amneal Pharmaceuticals, Inc. Unlike the well-known treatment carbidopa/levidopa, which is short-acting and can cause fluctuations in symptoms, CREXONT combines immediate-release granules with extended-release pellets to extend “Good On” time for people with Parkinson’s. The result is more “Good On” time with fewer doses than standard immediate-release carbidopa/levodopa.

“The treatment goals for people living with Parkinson’s disease include achieving a more robust duration of benefit per dose of LD, reducing ‘Off’ time, and simplifying dosing regimens. CREXONT’s longer ‘Good On’ time per day and per dose represents a substantial advancement in managing motor symptoms and maintaining more consistent therapeutic effects, which is very encouraging for both patients and the Parkinson’s community,” said Robert A. Hauser, M.D., Professor of Neurology at the University of South Florida and Director of the Parkinson’s Disease and Movement Disorders Center.

Amneal expects to make CREXONT available to patients in the U.S. in September 2024. If you’re experiencing “Off” times when you’re medications are wearing off between doses, talk to your doctor about your treatment options. To learn more about CREXONT, read Amneal’s press release on the company’s website.