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FDA Approves New Dosage Strength Of Stalevo(R) For People With Parkinsons

08 Aug 2007
http://www.medicalnewstoday.com/articles/78954.php

Novartis Pharmaceuticals Corporation announced that the U.S. Food and Drug Administration (FDA) has approved a new higher dose strength of Stalevo(R) (carbidopa, levodopa and entacapone) which is indicated for Parkinson's disease patients with signs and symptoms of end-of-dose "wearing off." 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.

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.

"There is a real need for this increased dosage strength of Stalevo," said Kapil Sethi, M.D., F.R.C.P., 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. In one tablet, the Stalevo 200 mg dose provides an additional treatment option for patients experiencing symptom re-emergence and may ease the burden of taking multiple tablets."

The Stalevo 200 mg dose was approved based on a bioequivalence study of Stalevo 200 (50 mg carbidopa, 200 mg levodopa, 200 mg entacapone) with 2 tablets of Sinemet(R) 100/25 mg (levodopa/carbidopa) taken concomitantly with Comtan(R) (entacapone 200 mg). Therefore implicating the same safety and efficacy of the comparator. The product will be available in October.

About Stalevo

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. Stalevo is already available in strengths of 50 mg, 100 mg and 150 mg.

Important Safety Information

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 diarrhea, hyperkinesias, urine discoloration, hypokinesia, abdominal pain, dizziness, constipation, fatigue, pain and hallucinations. Stalevo is contraindicated for use concomitantly for 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. For full prescribing information, visit http://www.stalevo.com.

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.

Disclaimer

This release contains certain forward-looking statements relating to Novartis' business which can be identified by forward-looking terminology such as "may," "will," or similar expressions, or by express or implied discussions regarding potential future revenue from Stalevo. Such forward-looking statements reflect the current views of the Company regarding future events, and involve known and unknown risks, uncertainties, assumptions 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 level. In particular, management's expectations regarding Stalevo could be affected by, among other things, unexpected clinical trial results, including additional analysis of existing clinical data or unexpected new clinical data; unexpected regulatory actions or delays or government regulation generally; the Company's ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry and general public pricing pressures, 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 develops, manufactures, markets and sells 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, gastrointestinal and respiratory areas. The company's mission is to improve people's lives by pioneering novel healthcare solutions.

Novartis has been a leader in the neuroscience area for more than 50 years, having pioneered early breakthrough treatments for Alzheimer's disease, Parkinson's disease, Attention Deficit Hyperactivity Disorder, epilepsy, schizophrenia and migraine, many of which continue to be regarded as "gold standards" to this day. Novartis Neuroscience continues to be at the forefront of research and development of new compounds, is committed to addressing unmet medical needs and to supporting patients and families affected by these disorders.

Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG (NYSE: NVS), a world leader in offering medicines to protect health, cure disease and improve well-being. Our goal is to discover, develop and successfully market innovative products to treat patients, ease suffering and enhance the quality of life. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low-cost generics, human vaccines and leading self-medication OTC brands. Novartis is the only company with leadership positions in these areas. In 2006, the Group's businesses achieved net sales of USD 37.0 billion and net income of USD 7.2 billion. Approximately USD 5.4 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 100,000 associates and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com.

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One of the side effects of Stalevo is abdominal pain.

This is the side effect that forced me off Stalevo.