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New Combination Drug for Parkinson’s Disease Receives FDA Approval

Novartis Pharmaceuticals Corporation announced on June 13 that the U.S. Food and Drug Administration (FDA) has approved Stalevo™ (carbidopa, levodopa and entacapone). The new combination tablet will be available to patients with idiopathic Parkinson’s disease (PD) who experience signs and symptoms of end-of-dose “wearing-off” by September 2003.

Stalevo™ combines levodopa, the most widely used agent for Parkinson’s disease, with carbidopa and entacapone. While carbidopa reduces the side effects of levodopa, entacapone extends its benefits, providing more levodopa to the brain for a longer period of time. Currently, levodopa and carbidopa are available in combination as Sinemet, the mainstay anti-Parkinson medication for more than 30 years. Entacapone, another Novartis product, is available separately under the trade name COMtan. Stalevo™ combines all three compounds.

The new combination tablet will benefit patients who after 4 or 5 years of receiving levodopa therapy begin to notice that their levodopa lasts for shorter periods of time, known as “wearing-off”. Eventually, the effect of a levodopa dose may decrease from eight hours, when patients begin levodopa therapy, to only one to two hours.

Potential benefits to Parkinson’s patients include increased “on-time” during which Parkinson’s symptoms are well-controlled. In addition, the combination tablet offers patients a convenience – instead of taking two pills (carbidopa-levodopa and entacapone), patients will now need to take just the one.

While the new combination tablet provides a simpler and more convenient alternative to the current option of taking the two compounds separately, the combination tablet may not be suited to all Parkinson’s patients since it reduces the ability to fine-tune the doses of entacapone to meet the needs of the individual.

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Source Date: Jun 23 2003