Summary
UCB's Neupro(R) (rotigotine) transdermal patch is back on the market in Europe for both Parkinson's Disease and RLS, which will benefit many patients with either of these disorders. Hopefully, the FDA will consider returning Neupro to the market in the United States for Parkinson's Disease and eventually for RLS. The advantage of a transdermal patch is the sustained release of lower doses of medicine, thereby decreasing the potential and intensity of side effects, especially habituation and augmentation, that are problems with pill delivery of dopamine precursor, l-dopa and dopamine agonists (though less than with the dopmaine precursor).
Analysis
As a restless legs syndrome (RLS) researcher, I am pleased to learn that UCB's Neupro(R) (rotigotine) transdermal patch is back on the market in Europe for both Parkinson's Disease and RLS. Although the FDA approved Neupro for Parkinson's Disease, the crystalization problem caused the FDA and the European Commission to recall it. Its return to the market in Europe, means that they are now satisfied with UCB's new storage instructions to prevent crystalization and that it now meets their standards for efficacy. The FDA will hopefully review the new evidence soon and also allow Neurpor to be returned to the market as a treatment for Parkinson's Disease in the USA and consider the evidence from clinical trials for the treatment of RLS when UCB completes the clinical trials and submits a NDA.
The advantage of Neupro over dopamine precursors, such as Mylan's Sinemet CR (levodopa and carbidopa) or dopamine agonists, such as Boehringer Ingelheim's Mirapex (pramipexole HCL) or Glasosmithkline's Requip (ropinirole HCL), is that it releases rotigotine slowly over a 24 hour period via the transdermal patch delivery system and should decrease the problem of dopamine receptor over-stimulation and dopamine receptor down regulation by more closely mirroring natural dopamine release levels, decreasing potential side effects, habituation and augmentation of symptoms that are associated with dopamine precursors and agonists and therefore will benefit many patients with Parkinson's Disease or wtih RLS.
There are new treatments in clinical trials for RLS that do not involve the dopamine neuromechanism, namely, Xenoport-Glaxosmithkline's Solzira (active transport or pro-gabapentin) and Pfizer's Lyrica (pregabalin). The clinical trial data for Solzira has been accepted for NDA consideration by the FDA.
