East Hanover, NJ, December 16, 2008 – Study results published online in Movement Disorders showed that Stalevo? (carbidopa, levodopa and entacapone) provides better symptom control and greater improvements in activities of daily living for people with early Parkinson’s disease (PD), than carbidopa/levodopa, the most widely-used current therapy.
The FIRST STEP study supports regulatory filings in 2008 for the use of Stalevo in patients with early PD who have not been treated with levodopa.
“The results of FIRST STEP indicate that Stalevo may be a valuable therapeutic option for patients with early Parkinson’s disease,” said Robert A. Hauser, MD, Professor of Neurology, Pharmacology and Experimental Therapeutics at the University of South Florida, and principal investigator of the study. “Patients with early Parkinson’s disease experienced better symptomatic benefit with Stalevo than with the most commonly-used mainstay therapy for the management of Parkinson’s disease.”
Stalevo is currently indicated for certain Parkinson’s disease patients who experience signs and symptoms of end-of-dose “wearing off.” This occurs when the dose of levodopa therapy that initially controlled their symptoms is no longer enough to maintain full control until the next scheduled dose.
In the FIRST STEP study in patients with early Parkinson’s disease, Stalevo showed a statistically significant improvement versus carbidopa/levodopa in the primary endpoint, which was the combined Unified Parkinson’s Disease Rating Scale (UPDRS) Part II-activities of daily living (e.g., eating, bathing, dressing) and Part III-motor scores (e.g., agility, rigidity, tremors) (p=0.045). The UPDRS is a standard Parkinson’s disease assessment instrument.
FIRST STEP (Favorability of Immediate-Release carbidopa/levodopa vs STalevo; Short-Term comparison in Early Parkinson’s) was a double-blind, randomized, parallel group, fixed-dose, clinical trial that included 423 patients with early Parkinson’s disease in eight countries.
Parkinson’s disease is a chronic and progressive disorder of the nervous system that affects approximately 1.5 million Americans. While its cause is unknown, the symptoms of Parkinson’s disease include tremor; slowness of movement; stiffness and rigidity of limbs; and balance problems. As the disease progresses, these symptoms usually increase and impact a person’s ability to function.
Stalevo simplifies dosing because it combines the most widely-used agent for treating Parkinson’s disease, levodopa, with enzyme inhibitors carbidopa and entacapone, to provide greater and more sustained levels of levodopa in the blood. It was approved by the U.S. Food and Drug Administration in June 2003 and by the European Commission in October 2003, and is now approved in 80 countries. Stalevo is developed and manufactured by Orion Corporation, and is marketed by Novartis and Orion in their respective territories.
Important Safety Information
The most common side effects of Stalevo are unwanted or uncontrollable movements (known as dyskinesia), nausea, diarrhea, excessive muscle movements (known as hyperkinesia), harmless discoloration of urine, sweat and/or saliva, diminished or slow movements (known as hypokinesia), abdominal pain, dizziness, constipation, fatigue, pain, and hallucinations. Some of the more serious side effects may include severe diarrhea, severe dyskinesia, hallucinations, other mental disturbances, orthostatic hypotension (low blood pressure), rhabdomyolysis (a muscle disease), and symptoms resembling neuroleptic malignant syndrome (a condition characterized by fever and muscle stiffness).
Be careful using Stalevo if you have severe heart or lung disease, asthma, renal, hepatic, or endocrine disease, or a history of heart attacks or ulcers. Do not take Stalevo if you have glaucoma, melanoma, or other related medical disorders.
Drugs broken down by the COMT enzyme (e.g., isoproterenol, epinephrine) should be used with caution when taking Stalevo. If you take a nonselective monoamine oxidase (MAO) inhibitor, you should not take Stalevo. Stalevo should not be taken with selegiline at doses higher than 10 mg/day.
Before you take Stalevo, talk to your doctor about any health problems you might have. For more information about Stalevo, read the full prescribing information. The prescribing information will explain how Stalevo will act in your body, possible side effects, drug interactions and precautions.
Tell your healthcare professional if you have side effects that bother you. He or she can make adjustments that may reduce those effects. You should not quickly lower your Stalevo dose or suddenly stop it altogether. Be sure to take your medicine as instructed.
Disclaimer
The foregoing release contains forward-looking statements which can be identified by the use of terminology such as “to expand,” “may,” or similar expressions, or by express or implied discussions regarding potential new indications or labeling for Stalevo, or regarding potential future sales of Stalevo. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of Novartis regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Stalevo will be approved for any additional indications or labeling in any market. Nor can there be any guarantee that Stalevo will reach any particular sales levels. In particular, management’s expectations regarding Stalevo could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; unexpected clinical trial results, including unexpected additional analysis of clinical data, or unexpected new clinical data; our ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; increased government, industry, and general public pricing pressures; the impact that the foregoing factors could have on the values attributed to the Novartis Group’s assets and liabilities as recorded in the Group’s consolidated balance sheet; and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
About Novartis
Novartis Pharmaceuticals Corporation researches, develops, manufactures and markets leading innovative prescription drugs used to treat a number of diseases and conditions, including those in the cardiovascular, metabolic, cancer, organ transplantation, central nervous system, dermatological, GI and respiratory areas. The company’s mission is to improve people’s lives by pioneering novel healthcare solutions.
Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG (NYSE: NVS), which provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on growth areas in healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, and consumer health products. Novartis is the only company with leading positions in these areas. In 2007, the Group’s continuing operations (excluding divestments in 2007) achieved net sales of USD 38.1 billion and net income of USD 6.5 billion. Approximately USD 6.4 billion was invested in R&D activities throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 98,200 full-time associates and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com.
