The U.S. Food and Drug Administration has given approval for the drug Stalevo-a cocktail of levodopa (L-dopa), carbidopa, and entacapone-to be marketed in the United States for the treatment of Parkinson's disease, according to a press release from the Finnish pharmaceutical company Orion Yhtyma Oyj. The drug is only approved for PD patients already taking these three drugs separately in similar doses, or those taking L-dopa at doses of 600 mg or less and not experiencing dyskinesias, the involuntary movements that plague many patients who are on L-dopa. The Swiss company Novartis will market Orion's drug in U.S.; European approval for the drug is still pending.

PD patients have a limited window-sometimes only a few years-during which L-dopa is effective in replacing the dopamine normally produced by the dying cells of the substantia nigra. One problem appears to be that L-dopa’s staying power decreases as enzymes increasingly scavenge the drug. According to Orion, the addition of entacapone and carbidopa to L-dopa in a single medication reduced motor impairment in a clinical trial of PD patients who no longer responded well to L-dopa.—Hakon Heimer

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  1. Novartis has recently received approval to market a new drug for Parkinson's disease, Stalevo. This is in fact a new formulation of several drugs which are currently on the market. Stalevo contains three different drugs in a single tablet: carbidopa and levodopa (sold as Sinemet or in generic form) together with entacapone (sold as Comtan). The active agent in this combination is levodopa, which is converted by the brain into dopamine. Both carbidopa and entacapone serve to inhibit enzymes which break down levodopa, and thereby increase the amount which can get into the brain.
    Entacapone (Comtan) has been on the market for several years, and has proven to be a useful adjunct to the treatment of Parkinson's disease. The main use is for patients who have developed problems with "wearing off," meaning that they find only a short duration of benefit from each dose of carbidopa/levodopa. While no drug is entirely free of side effects, Comtan has proved to be very well tolerated in many patients.
    So what is the advantage of Stalevo compared to taking carbidopa/levodopa and Comtan separately? The main one is likely to be convenience, with a smaller number of pills to take every day. This is no small thing for Parkinson's patients, who often take 20 or more pills a day. Another may be economic, depending on how the pricing of Stalevo (which as far as I know has not yet been announced) compares to Comtan and carbidopa/levodopa purchased separately.

  2. Stalevo provides a combination tablet containing L-dopa, carbidopa, and entocapone in a single tablet. The advantage of this formulation is mainly convenience, by reducing the number of tablets. The effect on cost is not yet known, as pricing has not been established for this product.

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