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Exercise Physiologist and Celebrity Trainer Bob Greene Leads National Campaign to Showcase Osteoarthritis Pain Management Techniques and New Treatment Approaches
Date:3/25/2009

MOVE Campaign Encourages Osteoarthritis Sufferers to Live Fit by Thinking Fit, Eating Fit, Feeling Fit and Getting Fit

CHADDS FORD, Pa., March 25 /PRNewswire/ -- Today, Bob Greene, best-selling author and personal trainer, will kick off a national initiative to help the 27 million Americans who suffer from osteoarthritis (OA) to live a healthier lifestyle. Supported by Endo Pharmaceuticals (Nasdaq: ENDP), the MOVE (Managing Osteoarthritis Via Education) Campaign's goal is to help people suffering from OA to manage joint pain and stiffness, as well as the overall impact of the disease, by learning how to live fit. The program is available online at MOVECampaign.com along with additional tips and OA patient resources.

OA is a chronic disease and major cause of disability characterized by the breakdown of cartilage between joints, causing bones to rub against each other. OA commonly affects joints in the hands and knees, and can cause mild to severe pain, stiffness, and loss of movement in the joints. As part of the campaign and to help OA sufferers get fit, Greene developed an exercise program specifically for people with OA which includes low-impact movements that take into consideration the specific needs of this group. Additionally, exercise can be beneficial for many of those OA patients who have co-existing conditions, such as diabetes and heart disease, as expert opinion indicates that regular exercise helps manage these conditions.

"Baby Boomers like me want to believe that 50 is the new 30 but some days, it just doesn't feel that way," said Greene. "I truly believe that age is a state of mind, and that osteoarthritis pain is not an inevitable sign of old age. I am excited to be a part of this campaign and to help people with osteoarthritis learn that exercise can help them. I want to help OA sufferers achieve the freedom they are looking for and to demonstrate that OA pain does not have to interfere with living a healthy life."

There are many things that can be done to help manage OA pain. It is important to manage weight, exercise appropriately and get proper rest. There also are many treatment options to help reduce OA pain, including oral medications, and topical options.

"I frequently hear my osteoarthritis patients describe movement as grating or catching, and they report that daily activities, such as getting out of bed and climbing stairs, are painful. In fact, pain is a common symptom of osteoarthritis, and controlling it is a primary treatment goal," said Steven Lamm, M.D., clinical assistant professor of medicine at New York University, Bellevue. "Voltaren(R) Gel helps these patients' pain by delivering targeted relief directly at the site of osteoarthritis pain, and offers well-tolerated and effective pain relief in the areas where it is needed most. Voltaren(R) Gel is the first and only prescription topical NSAID (non-steroidal anti-inflammatory drug) FDA-approved for the relief of OA pain in joints amenable to topical treatment, including the knees and those of the hands. The product has not been evaluated for use on the spine, hip or shoulder. The topical formulation of Voltaren(R) Gel, applied four times a day, encourages the patient to self-massage to help rub out OA pain."

Voltaren(R) Gel is a different type of osteoarthritis pain reliever that provides an effective amount of relief when applied at the site of pain. The amount of the active ingredient diclofenac sodium that is systemically absorbed from Voltaren(R) Gel is on average 6% of the systemic exposure from a comparable dose of an oral form of diclofenac sodium (four grams four times a day to one knee versus 50 milligrams three times a day orally). This means that Voltaren(R) Gel can be applied to targeted areas where pain relief is needed most, with low systemic levels. Additionally, by applying Voltaren(R) Gel four times daily as indicated, the levels of the medication remain steady throughout the day.

Cardiovascular Risk

  • Non-steroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.
  • Voltaren(R) Gel is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.

Gastrointestinal Risk

  • NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events.

About Osteoarthritis

Osteoarthritis is a chronic condition characterized by the breakdown of cartilage in the joint. Cartilage cushions the ends of the bones in joints -- such as knees, hands, elbows, wrists, ankles and feet -- which allows for easy movement. When cartilage erodes, bones can rub together, resulting in pain and loss of free movement in the joint. The most common symptoms include pain, joint soreness, and stiffness. Arthritis is the leading cause of disability in the U.S. Arthritis and related conditions, such as osteoarthritis, cost the U.S. economy nearly $128 billion per year in medical care and indirect expenses, including lost wages and production. Despite the high prevalence of osteoarthritis, there is no cure for this disease, but managing pain can help bring significant benefits.

About Voltaren(R) Gel

Voltaren(R) Gel provides 1% diclofenac sodium in a topical gel formulation. It is a non-steroidal anti-inflammatory (NSAID) medication indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands; the product has not been evaluated for use on the spine, hip or shoulder. Voltaren(R) Gel delivers effective pain relief with a favorable safety profile. The amount of diclofenac sodium that is systemically absorbed from Voltaren(R) Gel is on average 6% of the systemic exposure from a comparable dose of an oral form of diclofenac sodium (four grams four times a day to one knee versus 50 milligrams three times a day orally). Endo Pharmaceuticals Inc. has a licensing agreement with Novartis Consumer Health, Inc. and Novartis AG, granting Endo the exclusive U.S. marketing rights for Voltaren(R) Gel for the term of the agreement.

Important Safety Information

The most common adverse reactions reported in Voltaren(R) Gel clinical trials were application site reactions in 7% of treated patients. With all NSAIDs there may be an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. The use of Voltaren(R) Gel is contraindicated in patients with a known hypersensitivity to diclofenac. Voltaren(R) Gel should not be administered to patients who have experienced asthma, urticaria or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients. Voltaren(R) Gel is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.

Voltaren(R) Gel should not be used in combination with other oral NSAIDs or aspirin because of the potential for increased adverse effects. Similarly, combined use of Voltaren(R) Gel with other topical products, such as sunscreens and cosmetics, on the same skin area has not been tested and should be avoided because of the potential to alter local tolerability and absorption. Please see full prescribing information for warnings and contraindications.

About Endo

Endo Pharmaceuticals is a specialty pharmaceutical company engaged in the research, development, sale and marketing of branded and generic prescription pharmaceuticals used primarily to treat and manage pain. Its products include LIDODERM(R), a topical patch to relieve the pain of postherpetic neuralgia; PERCOCET(R) and PERCODAN(R) tablets for the relief of moderate-to-moderately severe pain; FROVA(R) tablets for the acute treatment of migraine attacks with or without aura in adults; OPANA(R) tablets for the relief of moderate-to-severe acute pain where the use of an opioid is appropriate; OPANA(R) ER tablets for the relief of moderate-to-severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time; and VOLTAREN(R) gel, a nonsteroidal anti-inflammatory drug indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands. VOLTAREN(R) gel has not been evaluated for use on the spine, hip, or shoulder. The company markets its branded pharmaceutical products to physicians in pain management, neurology, surgery, oncology, and primary care. More information, including this and past press releases of Endo Pharmaceuticals, is available at www.endo.com.

Safe Harbor Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the acquisition of Indevus, the company's financial position, results of operations, market position, product development and business strategy, as well as estimates of future net sales, future expenses, future net income and future earnings per share. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "intend," "guidance" or similar expressions are forward-looking statements. Because these statements reflect our current views, expectations and beliefs concerning future events, these forward-looking statements involve risks and uncertainties. Investors should note that many factors could affect our future financial results and could cause our actual results to differ materially from those expressed in forward-looking statements contained in this press release. These factors include, but are not limited to: the satisfaction of closing conditions for the acquisition, including clearance under the Hart-Scott-Rodino Antitrust Improvements Act; the possibility that the acquisition of Indevus is not complimentary to Endo; the inherent uncertainty of the timing and success of, and expense associated with, research, development, regulatory approval and commercialization of our products and pipeline products; competition in our industry, including for branded and generic products, and in connection with our acquisition of rights to assets, including intellectual property; government regulation of the pharmaceutical industry; our dependence on a small number of products and on outside manufacturers for the manufacture of our products; our dependence on third parties to supply raw materials and to provide services for certain core aspects of our business; new regulatory action or lawsuits relating to our use of controlled substances in many of our core products; our exposure to product liability claims and product recalls and the possibility that we may not be able to adequately insure ourselves; our ability to protect our proprietary technology; our ability to successfully implement our in-licensing and acquisition strategy; the availability of third-party reimbursement for our products; the outcome of any pending or future litigation or claims by the government; our dependence on sales to a limited number of large pharmacy chains and wholesale drug distributors for a large portion of our total net sales; a determination by a regulatory agency that we are engaging in inappropriate sales or marketing activities, including promoting the "off-label" use of our products; the loss of branded product exclusivity periods and related intellectual property; and exposure to securities that are subject to market risk including auction-rate securities the market for which is currently illiquid; and other risks and uncertainties, including those detailed from time to time in our periodic reports filed with the Securities and Exchange Commission, including our current reports on Form 8-K, quarterly reports on Form 10-Q and annual reports on Form 10-K, particularly the discussion under the caption "Item 1A, RISK FACTORS" in our annual report on Form 10-K for the year ended December 31, 2008, which was filed with the Securities and Exchange Commission on March 2, 2009. The forward-looking statements in this press release are qualified by these risk factors. These are factors that, individually or in the aggregate, we think could cause our actual results to differ materially from expected and historical results. We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.


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SOURCE Endo Pharmaceuticals
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