Patients experienced significant improvement in total UPDRS*, activities-of-daily-living (ADL), and motor scores vs levodopa as demonstrated in NOMECOMT, a randomized, double-blind, placebo-controlled, 24-week trial:

	Patients were experiencing "wearing off" between levodopa doses (n=171)
	Patients received levodopa/DDCI† + entacapone as separate tablets or levodopa/DDCI + placebo
	Patients were taking 4 to 10 daily doses of standard-release levodopa

The safety and tolerability of the components of STALEVO were tested and side effects were:

	Primarily dopaminergic in nature (eg, dyskinesia, nausea)
	Mild to moderate in severity

In approximately 1/3 of patients, side effects were managed by reducing the mean daily levodopa dose by an average of 25% upon initiation of entacapone.

Adverse events occurring in >5% of levodopa/DDCI + entacapone patients

Discontinuation rates due to adverse events

In rare cases, STALEVO therapy may be associated with hallucinations, other mental disturbances, orthostatic hypotension, rhabdomyolysis, severe diarrhea, dark saliva, and symptoms resembling neuroleptic malignant syndrome. Rapid withdrawal or abrupt reduction of levodopa therapy and entacapone should be avoided. STALEVO is contraindicated for use concomitantly with nonselective monoamine oxidase (MAO) inhibitors, with selegiline at doses >10 mg/day, in patients with narrow-angle glaucoma, and in patients with suspicious, undiagnosed skin lesions, or a history of melanoma. Drugs metabolized by the COMT enzyme (eg, isoproterenol, epinephrine) should be used with caution in patients receiving STALEVO.

*The UPDRS (Unified Parkinson's Disease Rating Scale) employs a 0- to 4-point scale on multiple items measuring total score, and including motor and ADL subscales as measures of overall disease severity. ADL and total scores were measured at baseline and Week 24. Motor scores were measured at baseline and Weeks 8, 16, and 24. Motor score change was calculated using baseline score and a mean of Weeks 8, 16, and 24.

†DDCI = Dopadecarboxylase (either benserazide or carbidopa).

Please see Important Safety Information.