Schwarz Pharma: Neupro to Improve Patient Convenience in Parkinson’s

The FDA has approved Schwarz Pharma’s Neupro, a transdermal patch formulation of the dopamine agonist rotigotine, for the treatment of early-stage Parkinson’s disease in the US. Although the once-daily formulation is expected to improve convenience for patients, the long-term success of Neupro looks set to be eclipsed by GlaxoSmithKline’s Requip XR.

Neupro is a transdermal patch formulation of the non-ergolinic dopamine agonist rotigotine, designed for once-daily application. As such, Neupro is the first product capable of delivering medication over a 24-hour period.

The approval of Neupro in the US for the treatment of early-stage idiopathic Parkinson’s disease (PD) follows the drug’s approval in the EU in February 2006. Schwarz Pharma plans to submit a supplemental New Drug Application for the treatment of advanced PD to the FDA by the end of 2007.

PD is a progressive, degenerative condition of the central nervous system characterized by tremor at rest, rigidity and bradykinesia (slowness of movement). PD is one of the most common neurodegenerative diseases and is estimated to affect 1.4 million individuals across the seven major markets.

Pharmacological therapy for PD predominantly comprises oral formulation tablets and capsules. Due to the progressive nature of PD, polypharmacy is frequently necessary when treating patients in the later stages of the disease. Consequently, there is a strong need for therapies that can reduce pill burden while maintaining efficacy.

Neupro’s novel method of administration represents a key advantage in terms of patient convenience, and in particular, an alternative treatment for a niche of patients who have difficulty in swallowing pills.

However, the PD market is currently saturated with dopamine agonists, which accounted for 52% of the total PD market in 2006. Furthermore, GSK’s Requip XR, a controlled release oral dopamine agonist, is expected to pose a long-term threat to Neupro’s sales and is forecast to achieve PD revenues of $210 million across the seven major markets by 2015. The convenient dosing of Requip XR is likely to be viewed more favorably than Schwarz’s Neupro patch; while the once-daily patch is a convenient method of delivery over multiple daily doses, a once-daily tablet is simpler still.