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]

EXTON, Penn.–(EON: Enhanced Online News)–Biogen Idec’s Avonex and Bayer’s Betaferon capture the greatest share of first-line prescribing of disease-modifying agents (DMAs) for the treatment of multiple sclerosis (MS) according to patient-level data provided by EU5 neurologists. when switching occurs, patients started on the most common first-line DMAs are likely to be switched to either Teva’s Copaxone or Biogen Idec’s Tysabri for their second-line DMA. Patient audit data show that relapse rate and disability progression reduction are the primary drivers of current DMA choice. however, a comparison of self-reported perceptions and audit data suggests that tolerability profile and route of administration may be more important in the choice of DMA brand than neurologists realize. overall, EU5 neurologists are highly satisfied with the clinical response achieved by just over one-half of their DMA-treated patients, although neurologists tend to be more satisfied with the clinical response achieved by patients currently treated with Avonex or Tysabri compared to those treated with Betaferon.

while the majority of EU5 neurologists agree that the availability of the anti-JC virus antibody assay would increase their prescribing of Tysabri, as of the time of study fielding, only 8% of DMA-treated audit patients had been tested with the assay. Patients currently treated with Tysabri represent 48% of assay-tested patients, although neurologists in the UK report testing significantly more of their patients prior to initiating any DMA therapy compared to neurologists in other EU5 countries.

the recently released ChartTrends®: Multiple Sclerosis in the EU report finds that 74% of DMA-treated audit patients currently experience at least some MS-related symptoms. while abnormal sensory perceptions, fatigue, and ataxia are the most common MS-related symptoms, depression / apathy, pain syndromes, spasticity, and bladder / bowel dysfunction are the symptoms most frequently managed using chronic pharmacotherapy. Almirall / Bayer’s Sativex, a symptomatic management agent recently approved for spasticity in the EU and commercially available in the UK and Spain at the time of fielding, has been prescribed to 7% of DMA-treated audit patients in the UK and Spain.

when asked to hypothetically switch audit patients to one of the DMAs in late stage clinical development, 44% of EU5 neurologists identify the greatest opportunity for Novartis’ Gilenya followed by Biogen Idec’s PEG-Avonex and Teva’s laquinimod. among audit patients identified as potential Gilenya candidates, the greatest percentage are currently prescribed Tysabri indicating that these two products may compete directly. a number of patient characteristics appear to help identify the types of patients who are perceived by neurologists as more likely to be switched to either Gilenya or one of the other DMAs in development.

ChartTrends®: Multiple Sclerosis is a syndicated annual patient audit designed to compare what physicians report about disease management to what actually occurs at the patient level. the 2011 audit captures information from 1068 patient charts provided by 228 neurologists from France, Germany, Spain, Italy, and the UK in April and may 2011. all patients are on a DMA at the time of the audit with all commercially-available DMA brands (Avonex, Betaferon, Copaxone, Extavia, Rebif, Tysabri) represented. a parallel report covering the U.S. market, which includes Novartis’ Gilenya, is also available. through an in-depth review of specific patient charts, details such as product initiation, switching, exacerbation management, and a host of test and patient demographic variables help define patient types and identify therapy triggers. Patient profiles for the seven DMAs in late clinical development (alemtuzumab, BG-12, teriflunomide, laquinimod, PEG-Avonex, daclizumab, ocrelizumab) are also characterized.

About BioTrends Research Group, LLC

BioTrends Research Group, LLC provides syndicated and custom market research to pharmaceutical manufacturers competing in clinically evolving, specialty pharmaceutical markets. For information on BioTrends publications and research capabilities, please contact us at (610) 363-3872 or bio-trends.com.

About decision Resources Group

decision Resources Group is a cohesive portfolio of companies that offers best-in-class, high-value information and insights on important sectors of the healthcare industry. Clients rely on this analysis and data to make informed decisions. Please visit decision Resources Group at DecisionResourcesGroup.com.

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