Two new dosage strengths of Stalevo® approved in the U.S. provide greater dosing flexibility for people with Parkinson’s disease
• New dosage strengths offer physicians more options to tailor treatment approaches for patients, and may lessen the burden of managing multiple medications
• Stalevo combines levodopa, a cornerstone of Parkinson’s therapy, with carbidopa and entacapone to provide longer-lasting symptom control than traditional levodopa therapy
• Approximately 1.5 million Americans suffer from Parkinson’s disease, a progressive and
disabling neurological condition
East Hanover, NJ, October 28, 2008 – Novartis Pharmaceuticals Corporation today announced the launch of two new FDA-approved dosage strengths of Stalevo® (carbidopa, levodopa and entacapone), which is indicated for certain people with Parkinson’s disease who experience end-of-dose “wearing off”. The approval of Stalevo 75 and 125 tablets (18.75 mg carbidopa, 75 mg levodopa, 200 mg entacapone and 31.25 mg carbidopa, 125 mg levodopa, 200 mg entacapone, respectively) provides physicians with options that may enable more customized approaches to treating people with Parkinson’s disease in the U.S. Now available in pharmacies, these new dosage strengths complement the already existing Stalevo 50, 100, 150 and 200 tablets, which may also help lessen the burden of managing multiple medications among people with Parkinson’s disease and their caregivers.
Stalevo simplifies treatment because it combines the most widely-used agent for treating Parkinson’s disease, levodopa, with the enzyme inhibitors carbidopa and entacapone, to provide greater and more sustained levels of levodopa in the blood. When patients start taking carbidopa/levodopa, they may experience benefits in terms of symptom control, but over time, those benefits may last for increasingly shorter periods of time, which is known as “wearing off”. As the therapy wears off, patients find that their symptoms begin to re-emerge prior to their next scheduled dose, which may impact their motor functions and daily activities. Stalevo significantly improves the ability of patients with “wearing off” to control body movements and perform daily activities, compared to traditional levodopa therapy.
“The new Stalevo 75 and 125 tablets are welcome additions to the treatment regimen for people with Parkinson’s disease who are experiencing the signs and symptoms of ‘wearing off’,” said Kapil D. Sethi, MD, Professor of Neurology, Director Movement Disorders Program at Medical College of GA in Augusta. “As the disease progresses, it can become increasingly difficult for patients to achieve clinical benefits. With six Stalevo dosage strengths, physicians have more prescribing flexibility, which may enable more individualized approaches to treating people with Parkinson’s disease.”
Stalevo is approved to substitute immediate-release carbidopa/levodopa and entacapone previously administered as individual products, or to replace immediate-release carbidopa/levodopa therapy, without entacapone, in certain Parkinson’s disease patients who are experiencing the signs and symptoms of end-of-dose “wearing off”.
Stalevo, originated and manufactured by Orion Corporation, was approved by the U.S. Food and Drug Administration (FDA) in June 2003 and is marketed in the United States by Novartis Pharmaceuticals Corporation.
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.
About Parkinson’s disease Parkinson’s disease, a chronic and progressive neurological condition, affects approximately 1.5 million Americans. 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 balance problems. As the disease progresses, these symptoms usually increase and impact a person’s ability to work and function.
The foregoing release contains forward-looking statements which can be identified by the use of terminology such as “may,” “approximately,” “usually,” or similar expressions, or by express or implied discussions 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 reach any particular sales levels. In particular, management’s expectations regarding Stalevo could be affected by, among other things, our ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; 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; increased government, industry, and general public pricing pressures; production delays or business interruption generally; 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.
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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 98,000 full-time associates and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com.