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Neupro Patch Ready for Long-awaited U.S. Comeback

An important development today for Americans with Parkinson’s disease (PD): Neupro, the only extended-release dopamine agonist in the form of a skin patch, has been approved by the U.S. Food and Drug Administration (FDA) to treat the symptoms associated with both early and advanced stage Parkinson's, and is expected to return to pharmacy shelves this July.

Developed by pharmaceutical company UCB and initially approved by the FDA in 2007, Neupro patches were withdrawn from the U.S. market in April 2008 when a manufacturing problem made it impossible for UCB to guarantee proper dosing.  Now, it appears those concerns have been addressed.

Dopamine agonists mimic how dopamine works in the brain, supplementing function that has been lost as dopamine-producing neurons die during the course of PD.

“The specific benefit of Neupro, like other extended-release dopamine agonists, is that it maintains as constant a level of drug as possible throughout the day, which could translate into longer ‘on’ periods for people with Parkinson’s,” says MJFF associate director of research programs Maurizio Facheris, MD.

Neupro also was taken off market for a short time in the European Union when researchers discovered that the drug crystallized when it got too warm. The patch has already been re-approved for use in the European Union, and users are advised to keep their patches in the refrigerator.

“Think of your Neupro like mozzarella,” says Facheris. “When you take it home from the supermarket, it’s okay for it to sit out on the counter while you’re cooking or putting away your groceries. But after that, it needs to go in the refrigerator.”

The patch is also now approved to treat Restless Leg Syndrome (RLS), an uncontrollable urge to move one’s legs when at rest. Extended release treatments for PD such as Neupro could have important implications for the many people with PD who experience difficulty sleeping, says Facheris. In addition to complications from RLS that often make it hard to sleep, rigidity can make it equally difficult to get some rest.  Unable to toss and turn, many spend countless waking hours during the night.  A more consistent treatment for PD such as Neupro could help to alleviate this stress.

UPDATE: The newly FDA-approved Neupro patch is an improved formulation that will not require refrigeration, according to UCB.

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