Symptomatic Treatment of Mild to Moderately Severe Alzheimers Dementia

Current Labeling Indication Statements across RegionsThe table below identifies for each of the five approved PD products the wording of the Indication section of the label (US and EU) at the time of initial approval and the currently approved Indication wording.

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Table 1.2 Comparison of Initial and Current Labeling Indication Statements for the Treatment of Parkinson's disease: United States and EuropeRegion: United States United States Initial United States Current Analysis

Drug Name SinemetSinemetIndication Statement It is indicated in the treatment of the symptoms of idiopathic Parkinson's disease (paralysis agitans), post-encephalitic parkinsonism, and symptomatic parkinsonism which may follow injury to

the nervous system by carbon monoxide intoxication and/or manganese intoxication. sinemet is indicated in these conditions to permit the administration of lower doses of levodopa with reduced nausea and vomiting, with more rapid dosage titration, with a somewhat smoother response, and with supplemental pyridoxine (vitamin B6).

In some patients a somewhat smoother antiparkinsonian effect results from therapy with sinemet than with levodopa. However, patients with markedly irregular ("on-off") responses to levodopa have not been shown to benefit from sinemet. It is indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. Carbidopa allows patients treated for Parkinson's disease to use much lower doses of levodopa. Some patients who responded poorly to levodopa have improved on sinemet. This is most likely due to decreased peripheral decarboxylation of levodopa caused by administration of carbidopa rather than by a primary effect of carbidopa on the nervous system. Carbidopa has not been shown to enhance the intrinsic efficacy of levodopa No new clinical trial data provided in supplement.

No meaningful difference in Indication wording.

Drug Name DuopaDuopaIndication Statement It is indicated for the treatment of motor fluctuations in patients with advanced Parkinsons disease No information on current label. N/A

Drug Name Rytary Rytary Indication Statement It is a combination of carbidopa (an aromatic amino acid decarboxylation inhibitor) and levodopa (an aromatic amino acid) indicated for the treatment of Parkinsons disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. No information on current label N/A

Drug Name RequipRequipIndication Statement It is indicated for the treatment of the signs and symptoms of idiopathic Parkinsons disease and for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). Requip is a non -ergoline dopamine agonist indicated for the treatment of Parkinsons disease (PD) and moderate -to-severe primary Restless Legs

Syndrome (RLS) The primary measure of effectiveness from the clinical trials was the mean percent reduction (improvement) from baseline in the UPDRS motor score. At the end of the 6-month trial, patients treated with requip showed improvement in motor score compared with placebo and the difference was statistically significant.

No significant change in labeling indication.

Drug Name Mirapex Mirapex Indication Statement Mirapex (pramipexole dihydrochloride) tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease and for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS) Mirapex tablets are indicated for the treatment of Parkinson's disease and he treatment of moderate-to-severe primary Restless Legs Syndrome When Mirapex tablets are used in combination with levodopa, a reduction of the levodopa dosage should be considered. In a controlled study in advanced Parkinson's disease, the dosage of levodopa was reduced by an average of 27% from baseline.

Drug Name EldeprylEldeprylIndication Statement It is indicated as an adjunct in the management of Parkinsonian patients being treated with levodopa/carbidopa who exhibit deterioration in the quality of their response to this therapy. It is indicated as an adjunct in the management of Parkinsonian patients being treated with levodopa/carbidopa who exhibit deterioration in the quality of their response to this therapy. No change in wording.

Drug Name Zelapar Zelapar Indication Statement Zelapar is indicated as an adjunct in the management of patients with Parkinsons disease being treated with levodopa/carbidopa who exhibit deterioration in the quality of their response to this therapy. There is no evidence from controlled studies that Zelapar has any beneficial effect in the absence of concurrent levodopa therapy. Zelapar, a monoamine oxidase type B (MAO-B) inhibitor, is indicated as an adjunct in the management of patients with Parkinsons disease being treated with levodopa/carbidopa who exhibit deterioration in the quality of their response to this therapy. It should not be administered along with other selegiline products (e.g.,Emsam or Eldepryl) because of the increased risk of non-selective MAO inhibition that may lead to a hypertensive crisis.

Drug Name Comtan Comtan Indication Statement Comtan should always be administered in association with levodopa/carbidopa. Entacapone has no antiparkinsonian effect of its own. Comtan is indicated as an adjunct to levodopa and carbidopa to treat end -of-dose wearing-off in patients with Parkinsons disease. Comtans effectiveness has not been systematically evaluated in patients with Parkinsons disease who do not experience end-of-dose wearing-off. Comtan should always be administered in association with levodopa and carbidopa. Entacapone has no antiparkinsonian effect of its own. In clinical studies, the majority of patients required a decrease in daily levodopa dose if their daily dose of levodopa had been greater than or equal to 800 mg or if patients had moderate or severe dyskinesia before beginning t...