Looks like you’re on the UK site. Choose another location to see content specific to your location

Home Industry News UCB announces FDA filing acceptance for Neupro

UCB announces FDA filing acceptance for Neupro

14th December 2007

UCB has announced that the US Food and Drug Administration (FDA) has accepted for filing the supplemental New Drug Application (sNDA) for the use of Neupro as adjunctive therapy with levodopa in adult patients with advance-stage Parkinson’s disease (PD).

The decision follows FDA approval for Neupro in the treatment of signs and symptoms of early-stage idiopathic PD, with the drug available in the US since July 2007.

Troy Cox, president of CNS Operations, commented: “We are excited that patients with all stages of Parkinson’s disease may soon benefit from Neupro’s 24-hour continuous drug delivery.”

The sNDA has been drawn from a series of trial which investigated the efficacy and safety of Neupro in more than 670 patients with advanced-stage PD.

Neupro showed clinical relevant reductions in ‘off’ time (periods when medication effects wear off and PD symptoms return) and favourable increases in ‘on’ time without troublesome dyskinesia (fragmented or jerky movements).

Peter A LeWitt, professor of neurology at the Wayne State School of Medicine, confirmed that the clinical studies showed that once-daily dosing may improve compliance compared to medications that require several daily doses.

UCB has also confirmed that the FDA has accepted for filing the sNDA for the use of Neupro in moderate-to-severe restless leg syndrome.

We currently have 6 jobs available in Pharmacy industry, find your perfect one now.

Stay informed

Receive the latest industry news, Tips
and straight to your inbox.