ST. LOUIS–(BUSINESS WIRE)–The American College of Rheumatology (ACR) Subcommittee on Osteoarthritis Guidelines has approved and issued several updates to clinical practice guidelines for the treatment of osteoarthritis (OA).

“We support the ACR treatment guidelines and believe topical NSAIDs, like PENNSAID, provide an effective option for reducing knee OA pain.”

the new guidelines, published in the April issue of Arthritis Care & Research, conditionally recommend that healthcare providers consider topical nonsteroidal anti-inflammatory drugs (NSAIDs) as one option for the initial management of knee OA, along with other treatments including acetaminophen, oral NSAIDs, tramadol and intraarticular corticosteroid injections. In addition, the guidelines strongly recommend the use of oral or topical NSAIDs or intraarticular corticosteroid injections in patients with an unsatisfactory clinical response to full-dose acetaminophen, and furthermore strongly recommend topical over oral NSAIDs in those patients aged 75 years or older initiating NSAID therapy.1

Commenting on the new guidelines, Marc C. Hochberg, MD, MPH, said, “Osteoarthritis is the most common form of arthritis affecting adults in the United States and is the principal cause of musculoskeletal pain, limitation in physical activity and reduction in health-related quality of life. it is important for all primary care providers and specialists taking care of patients with osteoarthritis to recognize that there is a lot that can be offered to the patient to reduce their pain and improve their function.” Dr. Hochberg is professor of medicine and epidemiology and public health, University of Maryland School of Medicine, Baltimore, and chair of the Task Force that developed the new ACR recommendations.

Knee OA is a chronic condition in which joint cartilage–the smooth tissue that cushions the bone and allows easy joint movement–breaks down, leading to pain and loss of physical function.2 Mallinckrodt LLC, a Covidien company, markets PENNSAID® (diclofenac sodium topical solution) 1.5% w/w, a topical NSAID. PENNSAID is the only U.S. Food and Drug Administration (FDA)-approved topical NSAID for the treatment of the signs and symptoms of knee OA, which demonstrated statistically significant differences in pain and physical function compared to placebo.

“Knee OA pain is one of the top five causes of disability in American adults,” said Alfredo Bozzini, Interim Chief Medical Officer, Pharmaceuticals, Covidien. “We support the ACR treatment guidelines and believe topical NSAIDs, like PENNSAID, provide an effective option for reducing knee OA pain.”

“The American College of Rheumatology osteoarthritis treatment guidelines propose to advance the use of topical NSAIDs beyond what the American Geriatric Society and American Academy of Orthopedic Surgeons recommend,” said Dr. Joseph Markenson, attending physician at the Hospital for Special Surgery and professor of clinical medicine at Weill Cornell Medical College. “The updated guidelines are helpful to physicians in their clinical practice, especially when seeing patients over 75 years of age.”

For Important Risk Information on PENNSAID, including boxed warning, see below.

About Osteoarthritis

OA 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 this cartilage erodes, bones can rub together, resulting in pain and loss of free movement in the joint. Today, an estimated 27 million Americans live with OA.2

the most common symptoms include pain, joint soreness, stiffness and deterioration of overall coordination, posture and walking. Despite the high prevalence of OA, there is no cure for this disease, which tends to progressively reduce mobility and the overall health state in affected patients.

About PENNSAID®

PENNSAID is the only FDA-approved topical NSAID for the treatment of knee OA which demonstrated statistically significant differences in all three primary efficacy endpoints: pain and physical function (WOMAC®), patient overall health assessment (POHA) and patient global assessment of knee OA.

INDICATION

PENNSAID is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s).

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WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISK

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Cardiovascular Risk

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• 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.

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• PENNSAID is contraindicated in the perioperative setting of coronary artery bypass graft (CABG) surgery.

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Gastrointestinal Risk

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• 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.

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IMPORTANT RISK INFORMATION

PENNSAID is also contraindicated in patients:

• with a known hypersensitivity to diclofenac sodium or any other component of PENNSAID
• who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal anaphylactic-like reactions to NSAIDs have been reported in such patients.

Elevation of one or more liver tests may occur during therapy with NSAIDs. PENNSAID should be discontinued immediately if abnormal liver tests persist or worsen.

use with caution in patients with fluid retention or heart failure. Hypertension can occur with NSAID treatment. Monitor blood pressure closely with PENNSAID treatment.

Long-term administration of NSAIDs can result in renal papillary necrosis and other renal injury.

use PENNSAID with caution in patients at greatest risk of this reaction, including the elderly, those with impaired renal function, heart failure, liver dysfunction, and those taking diuretics and ACE-inhibitors.

should not be used in pregnant or lactating women and is not approved for use in pediatric patients.

Anaphylactoid reactions may occur in patients without prior exposure to PENNSAID. NSAIDs can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal.

the most common treatment-related adverse events in patients receiving PENNSAID were application site skin reactions including dry skin (32%), contact dermatitis characterized by skin erythema and induration (9%), contact dermatitis with vesicles (2%) and pruritus (4%). In a long term safety study, contact dermatitis occurred in 13% and contact dermatitis with vesicles in 10% of patients, generally within the first 6 months of exposure, leading to a withdrawal rate for an application site event of 14%. Other common adverse events greater than placebo include: dyspepsia (9%), abdominal pain (6%), flatulence (4%), diarrhea (4%) and nausea (4%).

do not apply to open wounds. Protect treated knee(s) from natural or artificial sunlight. Topicals such as sunscreen and bug repellant may be applied after PENNSAID treated knee(s) are completely dry. Avoid contact of PENNSAID with eyes and mucous membranes. Wash and dry hands after use. Concurrent use with oral NSAIDs should be avoided unless benefit outweighs risk and periodic laboratory evaluations are conducted.

you are encouraged to report negative side effects of prescription drugs to the FDA. Visit fda.gov/medwatch or call 1-800-FDA-1088.

PENNSAID is a registered trademark of Nuvo Research inc.

WOMAC is a registered trademark of Nicholas Bellamy.

ABOUT COVIDIEN

Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence. Covidien manufactures, distributes and services a diverse range of industry-leading product lines in three segments: Medical Devices, Pharmaceuticals and Medical Supplies. With 2011 revenue of $11.6 billion, Covidien has 41,000 employees worldwide in more than 65 countries, and its products are sold in over 140 countries. please visit covidien.com to learn more about our business.

1 Hochberg M, Altman R, et al. American College of Rheumatology 2012 Recommendations for the use of Nonpharmacologic and Pharmacologic Therapies in Osteoarthritis of the Hand, Hip, and Knee. Arthritis Care & Research. 2012;64:465-474.

2 Arthritis Foundation. Osteoarthritis Fact Sheet. arthritis.org/media/newsroom/media-kits/Osteoarthritis_fact_sheet.pdf [Last Accessed January 10, 2012]

On 10th March 2011 researchers says that a new protein molecule derived from growth factor progranulin provide treatment for the inflammatory diseases like rheumatoid arthritis. the development of this protein in the body produces cytokines that control the level of cartilage. Appropriate level of cartilage prevents arthritis in the body. these protein molecules are secreted by the nervous system and other immune system of the body.Arthritis is taken from a Greek word which means “joint” and its Latin meaning is “inflammation”. it affects the muscles and the skeleton system of the human body specially the joints. it becomes the main cause of disability in the people of over 55 years of age.

Arthritis is not a single disease. it covers other medical conditions.

There are more than hundred types of arthritis. some are given below:

1. OsteoarthritisIt is a type of arthritis in which cartilage loses its elasticity. if the cartilage is stiff it damages easily. Cartilage functions as a shock absorber. when the cartilage is damaged the tendons and the ligaments are damaged too as a result it causes pain in the muscles and bones.

2. Rheumatoid arthritisIn this arthritis the muscle membrane is damaged and it causes swelling and pain. if this type of arthritis is not treated well it can cause deformity of bones. Rheumatoid arthritis is more common in women than in men and it strikes the patient between the age of 40 to 60. Children and older people can also be affected by this disease.

3. Infectious arthritisThe infection in the synovial fluid or in the tissue of bone can be caused by a bacteria but it can also be caused by the viruses and other fungi. these bacteria, fungi are spread in the body through a blood and it infects the nearby tissues and the bones too. the people who had arthritis ever before in their life and those who have such virus in their body, they have the more chances of developing arthritis.

4. Juvenile rheumatoid arthritisThis is a type of arthritis that affects an individual of age 16 or less. the juvenile rheumatoid arthritis is of three types:

• Pauciarticular JRA

It is the most common type. In this a child feels pain in up to 4 joints.

• Polyarticular JRA

The affects of this arthritis are more severe and it gets worst with the passage of time.

• Systematic JRA

It is the least common type of arthritis. it can spread to the distant organs of the body but it can be the most dangerous type of JRA.

A joint where one bone is joined to another bone that joint is hold with the ligaments. these ligaments are elastic bands they keep bones at their place and the muscles contact and relax to make the joint move freely.

The cartilage allows the two bones not to rub with each other while moving. the covering of the cartilage helps the joint to move smoothly and painlessly.There is a capsule that surrounds the joint. There is fluid in the joint known as synovial joint. this fluid is beneficial for beneficial for bones.

If an individual has the arthritis things go wrong with bones. the damage that is caused to the bones depends on the type of the arthritis. as a result of the arthritis the cartilage finishes due to infection and many other factors.

The symptoms of arthritis takes time to develop but it get worse with the passage of time. these symptoms affect the joints of hip, knee, hands and spine, fingers, arms, legs, wrists, ankle, jaw, shoulder. Following are the symptoms of arthritis:

Arthritis can be diagnosed blood tests, physical tests. x- Rays and CT scan.

Treatment of arthritis consists of physical therapy, medications.

Physical therapyPhysical therapy is helpful to maintain the flexibility of the bones. There are many types of physical therapies. the type of physical therapy given to a patient depends on the type of arthritis an individual has. different exercises are given to the patient that stabilize weaken joints. Exercise is an important part of arthritis therapy.

Medication for arthritisNSAIDs, COX-2 inhibitors, Salicylates, Glucocorticoids, Anti Malarials, Minocycline, and cyclosporine are the medicines that are used to cure the arthritis.

Diet impact on arthritisDiet has an important impact on the arthritis. it provides you with nutrition and it also maintains the weight of the body because people start losing weight during arthritis.

Doctors advised patients to avoid eating fats, cream, red meat and cheese. Patients should eat plenty of vegetables, fruits etc.

The prevention of arthritis can seem very difficult but there are many ways that can prevent arthritis from occurring. the use of arthritis supplements (Glucosamine and Cetyl myristoleate) also helps to prevent the arthritis. these supplements can be found in the form of liquid, powder or pills.the disease of arthritis can make one’s life very difficult but therapies can make life better. People with arthritis can go for medical health and treatment and there is no definite cure of arthritis but there are ways which can reduce the effects of arthritis. it affects the people in different ways patients may feel uncomfortable that they lose their grip. Being diagnosed with arthritis does not mean that you cannot live healthy life anymore. with some changes in life style the bad effects of arthritis can be removed.

Posted on: Tuesday, 18 January 2011, 15:27 CST

The amount of uric acid in one’s joints may increase the likelihood of severe osteoarthritis, the most common form of arthritis worldwide, according to researchers at Duke University Medical Center.

Osteoarthritis is a debilitating joint degeneration for which no drug has been proven to slow or halt its progression. Physicians can only offer to treat the symptoms associated with osteoarthritis, and people with the condition are often subject to a reduced quality of life.

"Finding a way to treat the degenerating joints of people with osteoarthritis would be a tremendous breakthrough," said Virginia Byers Kraus, M.D., Ph.D., professor of medicine at Duke University in the Division of Rheumatology and Immunology and senior author of the study. "this research is a step towards identifying uric acid as a risk factor for osteoarthritis."

The researchers looked at 159 people, who had knee osteoarthritis but no history of gout, a type of arthritis triggered by uric acid crystals in the joints. the researchers found the severity of osteoarthritis in their knees to be strongly correlated with the amount of uric acid in their knees. the results, which are published online in PNAS, show, despite the lack of gout history, above normal uric acid levels in 39 percent of the study population, and evidence of the form of inflammation in the joints that is typically triggered by uric acid crystals.

"in a non-gout population, this provides some of the very first evidence that uric acid level is a potential cause of inflammatory events and joint degeneration in osteoarthritis," Kraus said.

But there are many drugs available for lowering uric acid. "So the next question would be, if you are able to lower uric acid levels in an osteoarthritis sufferer, could you actually slow down the progression of their osteoarthritis and bring about a meaningful change in the course of their disease," Kraus said.

There are a lot of different markers for osteoarthritis that are indicative of disease severity, according to Kraus. "this is presumably a marker that is also a mediator of the disease process, not just a marker of the amount of disease you have," she said.

Kraus and her colleagues believe this to be true because the uric acid was so strongly associated with the severity of disease and linked to disease progression over time.

Kraus called the results extremely exciting. "I haven’t been this excited about anything I’ve ever done," she said. "It’s so innately treatable."

Current treatment for people with high uric acid levels and symptoms of gout involves uric acid-lowering drugs.

"We’ve always thought of uric acid as the agent for gout, but it may be a much more general agent," Kraus said.

There’s even an emerging interest in uric acid as a mediator of other types of disease, like chronic kidney disease and coronary artery disease, Kraus said.

"Duke has great strengths in gout disease and osteoarthritis, so we think it’s the perfect situation for pursuing evaluations of the interface between the two, trying to determine whether uric acid should be lowered to help prevent the onset or progression of osteoarthritis," she said.

On the Net:

• Duke University Medical Center
• PNAS

More News in this Category

TransPharma Medical ltd., a specialty pharmaceutical company focused on the development and commercialization of drug products utilizing a proprietary active transdermal drug delivery technology, announced today successful results of a Phase I clinical trial of its self-applied ViaDerm-Calcitonin product for the treatment of musculoskeletal disorders such as osteoarthritis and musculoskeletal pain.

the Phase I study was an open label single dose cross-over trial to assess the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of ViaDerm-Calcitonin in 12 postmenopausal women treated with 4 different transdermal Calcitonin doses (60-300 mcg) compared to 100IU of Miacalcin, the subcutaneous injected form of the Calcitonin.

Study results demonstrated a clear PK dose response corresponding to the escalating doses of the ViaDerm-Calcitonin patches. furthermore, a single administration of ViaDerm-Calcitonin resulted in a statistically significant reduction of bone resorption and cartilage degradation biomarkers, CTX-I and CTX-II, similar to the reduction obtained with daily injections of 100 IU Miacalcin. all doses of ViaDerm-Calcitonin were safe and well-tolerated and demonstrated a favorable profile with regard to skin safety.

Calcitonin is commercially available in subcutaneous, intramuscular and nasal routes for the treatment of postmenopausal osteoporosis, hypercalcemia, and Paget’s disease. Calcitonin is a very safe drug that has been widely used for many years and is currently being assayed for the treatment of osteoarthritis and various musculoskeletal clinical painful conditions.

“We are very pleased with the results of this study, which demonstrate that our transdermal Calcitonin is safe and as efficacious as a subcutaneous injection,” said Dr. Daphna Heffetz, CEO of TransPharma Medical. “It leads us to believe that enhancing these capabilities with the ease of use, virtual painlessness, small size and portability of our ViaDerm system may open up a myriad of possibilities to expand the therapeutic applications of Calcitonin beyond the current approved indications.”

About the Self Applied ViaDerm Drug Delivery System

TransPharma’s ViaDerm drug delivery system incorporates a handheld electronic device, which creates microscopic passageways through the outer layer of the skin allowing for transdermal delivery of a wide variety of drugs from a patch. the system provides a cost-effective, easy-to-use, virtually pain-free, self-administered solution that enables the safe, reproducible and accurate delivery of a broad range of product candidates, including hydrophilic small molecule such as peptides and proteins.

About Osteoarthritis

Osteoarthritis is a degenerative joint disease involving gradual degradation of joints. Symptoms may include joint pain, tenderness, stiffness, locking of the joint and swelling. When bone surfaces become less well protected by the loss of cartilage, the bone may be damaged, leading to the various Osteoarthritis symptoms, and a decreased quality of life. In severe cases the joint might need replacement surgery. Osteoarthritis is the leading cause of chronic disability, affecting nearly 27 million people and totaling $60 billion annually in related healthcare costs in the U.S. alone.

About Musculoskeletal Pain

Non-malignant musculoskeletal pain is the most common clinical symptom that causes patients to seek medical attention and is the major cause of disability in the world. Musculoskeletal pain can arise from a variety of common conditions including osteoarthritis, rheumatoid arthritis, osteoporosis, surgery, low back pain, and bone fracture. the musculoskeletal market is the sixth largest therapeutic category by sales.

About TransPharma Medical

Established in 2000, TransPharma Medical ltd. is a specialty pharmaceutical company focused on the development and commercialization of drug products utilizing its proprietary active transdermal drug delivery technology. the company aims to develop multiple drug products through strategic partnerships with leading pharmaceutical companies and through independent product development. TransPharma currently has 3 drug products in clinical trials: ViaDerm-hPTH (1-34) product for the treatment of osteoporosis developed in collaboration with Eli Lilly and currently in Phase 2b clinical studies; ViaDerm-GLP1 agonist for the treatment of type II diabetes that has completed phase 1b clinical study; and the ViaDerm-Calcitonin which has completed a Phase 1 clinical trial. For more information, please visit the Company’s website at transpharma-medical.com.

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Last updated on: 11/01/2011 10:00:01