 |
 |
hi all fwd from murray charters info as supplied by the drug manufacturer behemoth Novartis to their public relations newswire complete with current stock price if you are a stock investor, buyer beware if you are a parky, buyer beware health care at the best of times is a not-for-profit enterprise in my humble opinion throwing more money and more meds at pd is no answer polypharmacy is potentially fatal to parkies pd care requires chronic and progressive adjustments to brain chemistry with consequences to all body systems cognitive, emotional, intellectual, gastrointestinal, endocrinal etc not just movement one size does not fit all or even most parkies our meds need to be adjusted one at a time titrated over weeks and not days or hours and tuned to each individual's response heck we have hardly figured out the optimum options and long-term adjustments between levodopa and carbidopa yet the size of an entacapone dose affects the effectiveness of the current levodopa dose and generally requires some 25% reduction of levodopa how does a tablet with fixed proportions of entacapone and levodopa assist in the micro adjustment and fine tuning which is the essence of long-term pd med management? in my humble opinion this is a bad idea i disagree with dr. olanow's description of this product as offering "improved, and simpler, more convenient dosing" a seemingly simple 'quick fix' answer to a complex question which carries within its premise the potentisl for multiple med overdose and mismanagement a 'new med' for pd this isn't a new med managemnt idea for pd maybe, but a poor one and one fraught with potential dangers see my website for joe bruckbauer's (fatal), greg leeman's (criminal), and karen bardo's (psychological) stories in re pd med management and mismanagement janet levodopa/carbidopa/selegiline/fluoxetine adjuster and tweaker since 1988 = 15 years x 365 days x 8 doses (avg) x 100mg (avg) = 4,300,000 milligrams of levodopa later ------------------------------------------------------------- FDA Approves Stalevo (TM) for Treatment of Parkinson's Disease New Drug Reduces Signs and Symptoms of Disease. NVS $40.24 -0.22 -0.5% EAST HANOVER, N.J., Jun 13, 2003 /PRNewswire via COMTEX/ -- Novartis Pharmaceuticals Corporation today announced that the U.S. Food and Drug Administration (FDA) has approved Stalevo (carbidopa, levodopa and entacapone) tablets, the first new drug for Parkinson's disease in over three years, for 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 extends 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 PD patients receiving levodopa therapy begin to notice that their levodopa lasts for shorter periods of time, known as "wearing off." 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 more "on" time during which Parkinson's symptoms are well-controlled and daily activities are improved, and simpler, more convenient dosing." "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, this combination increased "on" time, reduced "off" time and improved motor function and daily activities such as patients' ability to walk and dress. 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. For full prescribing information, visit www.stalevo.com. 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 gait or balance problems. As the disease progresses, these symptoms usually increase and impact a person's ability to work and function. Entacapone alone is sold in the United States as Comtan (R) and like Stalevo is marketed by Novartis Pharmaceuticals Corporation and manufactured by Orion Pharma. This release contains certain forward-looking statements relating to Novartis Pharmaceuticals Corporation's business, which can be identified by the use of forward-looking terminology, such as "new", "can" and "introduce" or similar expressions, or by discussions of strategy, plans or intentions. Such forward looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results to be materially different from any future results, performance, or achievements expressed or implied by such statements. Commercialization can be affected by, amongst other things, uncertainties relating to regulatory actions or delays or government regulation generally, the ability to obtain or maintain patent or other proprietary intellectual property protection and competition in general, as well as factors discussed in the Company's Form 20F filed with the 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 described herein as anticipated, believed, estimated or expected. Novartis Pharmaceuticals Corporation researches, develops, manufacturers and markets leading innovative prescription drugs used to treat a number of diseases and conditions, including central nervous system disorders, organ transplantation, cardiovascular diseases, dermatological diseases, respiratory disorders, cancer and arthritis. 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. Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2002, the Group's businesses achieved sales of USD 20.9 billion and a net income of USD 4.7 billion. The Group invested approximately USD 2.8 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 77,200 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com. http://www.prnewswire.com 2003 PR Newswire ------------------------------------------------------------- janet paterson: an akinetic rigid subtype, albeit primarily perky, parky pd: 56-41-37 cd: 56-44-43 tel: 613-256-8340 email: [log in to unmask] my newsletter: http://groups.yahoo.com/group/newvoicenews/ my website: http://www.geocities.com/janet313/ ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn