Schwarz applies for advanced Parkinson’s drug EU approval

Schwarz Pharma has submitted an application to the European Medicines Agency for Neupro, its rotigotine transdermal patch for Parkinson’s disease.

Neupro is already used as a monotherapy for patients with early stage Parkinson’s, but the drug’s latest application is for its use as a combination therapy with levodopa.

Phase III clinical trials revealed that the reduction in off-time in patients with advanced Parkinson’s disease was statistically significant, in comparison to the placebo. In addition, the amount of on-time observed without dyskinesia (random, sudden movements caused by the chemical imbalances in the brain), was also increased by a “favourable degree”.

In April, data presented at the annual meeting of the American Academy of Neurology from a phase III trial of Neupro in patients with early stage Parkinson’s showed a statistically significant improvement in symptoms according to the Unified Parkinson’s Disease Rating.

Ray L Watts, chair of the department of neurology at the University of Alabama, stated: “These latest open-label data demonstrate rotigotine transdermal patch administered once-daily reduced the frequency and severity of early Parkinson’s disease symptoms and was well tolerated.”

Current treatment for Parkinson’s disease include levodopa, an amino acid used as a treatment since the 1960s, according to the Parkinson’s Disease Society, and Madopar – a faster acting drug than levodopa.

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