FDA Headquarters
The U.S. Food and Drug Administration (FDA) will be re-reviewing ND0612, a 24-hour, under-the-skin infusion of liquid levodopa/carbidopa, with a decision expected by the end of 2025.
ND0612 previously went before the FDA, but it received what is known as a “Complete Response Letter” in 2024, requiring the drugmaker behind the therapy to address certain concerns before the FDA would reconsider approving. The FDA requested more safety data on ND0612's carbidopa ingredient, along with further details on product quality, device, and manufacturing site inspections. The FDA announced in May that it accepted a resubmission of a New Drug Application for ND0612, which received early developmental support from The Michael J. Fox Foundation.
If cleared, this would mark the third approval for an under-the-skin infusion therapy, with Onapgo and Vyalev receiving approval in 2024.
This therapy is a 24-hour, under-the-skin infusion of liquid levodopa/carbidopa, intended to treat motor fluctuations (ups and downs in symptom control throughout the day) in people with Parkinson’s. Unlike oral medications, it bypasses the stomach, aiming to ensure consistent levels for 24-hour symptom relief. This approach may help those with Parkinson's who experience motor fluctuations that oral medications cannot manage effectively.
The therapy showed positive results in a Phase III trial, essentially the last step in the research cycle before the FDA considers a drug. In this instance, researchers conducted a 12-week trial where people with Parkinson’s were given either levodopa/carbidopa pills or ND0612. Those on ND0612 had roughly 1.75 hours more of "on" time without major symptoms like tremors, slowness, stiffness, or dyskinesia. The most common side effects were infusion site reactions such as bruising, swelling, and bleeding. These results are bolstered by similarly promising results from three years of tracking in an open-label study.
The therapy was developed by NeuroDerm, with support from The Michael J. Fox Foundation. NeuroDerm has since been acquired by Mitsubishi Tanabe Pharma Corporation (MTPC).