The recent removal from the United States market of the dopamine agonist patch (Rotigotine, Neupro) resulted in a shock wave that reverberated throughout the Parkinson’s disease (PD) community. Why the big deal? Well, because patients, families, and physicians who have a stake in Parkinson’s disease, know from experience that sufferers can be dominated by multiple daily pills taken at very frequent intervals (sometimes as close as every 1-2 hours). Also, memory problems, issues with swallowing, and problems with hand dexterity can all impact the use of common pill-form drugs.
The quality of life for the patient with Parkinson’s needs to remain a critical agenda issue when considering the development of new therapies. Deep brain stimulation, duodopa pumps, and apomorphine pumps all have the potential in select patients to improve symptoms and quality of life through a mechanism referred to as continuous therapy (dopaminergic or electrical). These therapies, that require surgical insertion, can in select cases, harness the potential to decrease medication doses, and allow a reduction in the frequency of medication use throughout a day. The therapies are all invasive, requiring surgical placement, and they are currently limited to only a few well-selected patients. The patch, however, when available was a once a day alternative for patients using only medication therapy. Like surgical therapies, the patch also only worked or was appropriate for a select group of patients due to both risks and side effects.
At the Parkinson's Foundation, we have recently received many reports that patients with Parkinson’s disease were very disappointed following the news that the Rotigotine patch (Neupro) was temporarily removed from the market. The consistent story was that the patch enhanced quality of life, by reducing the need for continuous re-dosing of medications throughout the span of a day. Although there were several dopamine agonist pill formulations available, many patients felt the patch was their optimal solution. The patch issue that precipitated removal from pharmacies was an observed “crystalization” of the medication into what appeared to be “snowflakes,” on the exterior surface. After scientific review, it was discovered that storage in a refrigerated environment was a potential solution. The patch underwent review by the FDA, and a panel determined that to be re-approved, the drug would require reformulation. This reformulation process could take as long as a year or two.
Many experts have pushed the concept of continuous dopamine stimulation arguing that it may postpone dyskinesia and other drug-related complications. In other words, it may be preferable to have a steady state of the minimal amount of dopamine required throughout the course of a day-- in order to delay complications. This notion is controversial, however what is not controversial is that the development of any strategy that can keep a Parkinson’s disease patient in their best “on” state throughout the day should and in most cases will enhance quality of life. If that can be accomplished without continuous round the clock dosing of medications in the form of a patch or any other strategy—the Parkinson’s disease community will likely be very appreciative.
There have been scientifically challenging issues in getting levodopa and dopamine agonists to work properly in patch formulations. Additionally, patches may result in skin irritation, and be subject to the same side effect profiles as drugs taken by mouth (e.g. edema, dizziness, nausea, sleepiness, compulsive behavior, etc.). Despite these limitations, scientists continue to work in this area, and we are hopeful for new developments and new approaches to continuous stimulation. We have been bolstered by the recent availability of the Exelon patch for cognitive dysfunction, and other companies are following suit in this arena.
Ultimately, the big deal about temporarily losing the patch in the United States was bigger than losing a single medication. The patch provided hope for those suffering with Parkinson’s disease. A hope that new formulations of drugs were on the way and that these drugs would meet a growing and important need. The truth is, that despite the delays, it is fair to say, hope will eventually arrive—and that more patches and innovative therapies will be here soon.
You can find out more about our National Medical Director, Dr. Michael S. Okun, by also visiting the Center of Excellence, University of Florida Health Center for Movement Disorders and Neurorestoration. Dr. Okun is also the author of the Amazon #1 Parkinson's Best Seller 10 Secrets to a Happier Life and 10 Breakthrough Therapies for Parkinson's Disease.