Germany's Schwarz Pharma is seeking a nod for its Parkinson's disease patch, Neupro, from regulators in Europe.
Neupro (rotigotine) is a dopamine receptor agonist formulated into a patch that is applied to the skin once-daily. It has already been cleared for approval in Europe for treating early-stage Parkinson's, with launches having taken place in Germany, the UK and Austria, and now the firm is hoping to expand this labelling to include patients with advanced disease.
Schwarz' dossier includes data from a Phase III trial showing patients had a significant reduction in so-called 'off' time - the cyclical on and off time that is a hallmark of conventional dopamine therapy - and an improvement in 'on' time, with no 'troublesome' dyskinesia (involuntary movements occurring as a side effect of medication) observed.
Last year, Schwarz said that Neupro (rotigotine) has peak sales potential of around 350 million euros ($417m) a year, but this figure could be boosted an additional 300 million euros annually if it is also successful in developing the compound for restless legs syndrome.