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FDA Approves Stalevo (Carbidopa, Levodopa, Entacapone) For Treatment Of Parkinson's Disease

New drug reduces signs and symptoms of disease

BASEL, SWITZERLAND -- June 13, 2003 -- Novartis announced today that the U.S. Food and Drug Administration (FDA) has approved Stalevo™ (carbidopa, levodopa and entacapone) tablets, for the treatment of patients with idiopathic Parkinson's disease (PD) who experience signs and symptoms of end-of-dose "wearing-off."

Stalevo contains levodopa, the most widely used agent for Parkinson's disease, plus carbidopa and entacapone. While carbidopa reduces the side effects of levodopa, entacapone optimizes its benefits, permitting Parkinson's disease patients to have an improved ability to perform everyday tasks and a reduction in symptoms associated with the disease.

Within one to two years, almost 50 percent of Parkinson's disease patients receiving levodopa therapy begin to notice that their levodopa lasts for shorter periods of time, a phenomenon known as "wearing off."1 In about 15 to 20 percent of patients, "wearing off "becomes extreme and disabling. Eventually, the effect of a levodopa dose may decrease from eight hours when patients begin levodopa therapy to only one to two hours. "Levodopa is recognized as the cornerstone of Parkinson's disease therapy, but its long-term use is limited by its reduced ability to fully control Parkinson's disease symptoms," said Warren Olanow, MD, professor and chairman, Department of Neurology, Mount Sinai School of Medicine in New York City. "By blocking the enzymatic breakdown of levodopa, Stalevo provides more levodopa to the brain for a longer period of time. Potential patient benefits include simpler, more convenient dosing and more "on" time, during which Parkinson's symptoms are well-controlled and daily activities are improved."

"We are proud to introduce a product like Stalevo which can enhance the daily lives of many people with Parkinson's disease," stated Paulo Costa, president and CEO, Novartis Pharmaceuticals Corporation. "As the fourth Parkinson's drug Novartis has introduced in the United States, Stalevo is a clear example of our company's ongoing commitment to the Parkinson's community."

The effectiveness of levodopa administered with carbidopa and entacapone in the treatment of Parkinson's disease was established in three 24-week multicenter, randomized, double-blind placebo-controlled trials in patients with Parkinson's disease experiencing "wearing off". In these trials, patients benefited from increased "on" time, reduced "off" time, improved motor function and daily activities such as patients' ability to walk, dress, and maintain hygiene. The most common side effects of Stalevo therapy are dopaminergic in nature (e.g. dyskinesia, nausea). These side effects may be manageable with alteration in the drug dosing schedule. Other common side effects include diarrhoea, hyperkinesias, urine discoloration, hypokinesia, abdominal pain, dizziness, constipation, fatigue, pain and hallucinations.

About Parkinson's disease
Parkinson's disease, a chronic and progressive neurological condition, affects more than 1% of people over 65 years old. While its cause is unknown, the symptoms of Parkinson's disease are primarily the result of degeneration of dopaminergic cells, or neurons, in the substantia nigra, a part of the brain that controls and modulates movement. Symptoms include limbs that tremble; slowness of movement; stiffness and rigidity of limbs and gait or balance problems. As the disease progresses, these symptoms usually increase and impact a person's ability to work and function. Stalevo will be marketed in the United States by Novartis Pharmaceuticals Corporation and manufactured by Orion Pharma.

References:
1 Parkinson Study Group. Pramipexole vs. levodopa as initial treatment for Parkinson disease. A randomized controlled trial. JAMA 2000;284:1931-1938


SOURCE: Novartis International AG

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