Novartis Pharmaceuticals Corporation today announced that the U.S. Food and Drug Administration (FDA) has approved a new higher dose strength of Stalevo (carbidopa, levodopa and entacapone) which is indicated for Parkinson's disease patients with signs and symptoms of end-of-dose "wearing off."
In the middle stages of Parkinson's disease patients often notice their levodopa wearing off faster than it used to. By adding one additional ingredient, entacapone, many people notice additional improvement. When patients first take levodopa they have initial benefits in terms of symptom control, but over time, those benefits last for increasingly shorter periods of time. As traditional levodopa wears off, patients find their symptoms begin to re-emerge. With this symptom re-emergence due to end-of-dose "wearing off," it may become difficult to perform even the most basic of functions, such as walking and dressing.
The approval of the Stalevo 200 mg dose (50 mg carbidopa, 200 mg levodopa, 200 mg entacapone) provides physicians with greater dosing flexibility in the treatment of Parkinson's disease patients experiencing symptom re-emergence due to end-of-dose "wearing off." The introduction of this new dosage strength may lessen the burden of managing multiple medications among patients and their caregivers.
Stalevo simplifies treatment because it combines levodopa, the most widely used agent for treating Parkinson's disease, with carbidopa and entacapone to provide more consistent and reliable levels of levodopa to the brain. The addition of entacapone to levodopa delays the breakdown of levodopa and extends the duration of effect of each dose of levodopa.
Stalevo significantly improves Parkinson's disease patients' ability to control body movements and the ability to perform basic functions, such as walking and dressing, compared to traditional levodopa therapy.
"There is a real need for this increased dosage strength of Stalevo," said Kapil Sethi, M.D., Director of the Movement Disorders Program at the Medical College of Georgia. "As the disease progresses, physicians are prescribing higher doses of levodopa to control symptoms and help manage symptom re-emergence between medication doses. As a result, many patients are taking multiple tablets to achieve a clinical benefit."
Sources:
Novartis
PharmaLive.com