MobicMobicMobic approvalMobic escapes boxed warning.MOBIC - Brief Article

> The Food and Drug Administration has approved the use of Mobic as a treatment for rheumatoid arthritis. Boehringer Ingelheim Inc. launched the drug four years ago for treating osteoarthritis, the most common form of the disease. Because Mobic is a nonsteroidal anti-inflammatory drug (linked to ulcers and bleeding), the FDA says patients should take doses of Mobic no greater than 15 milligrams (once daily).
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MobicMobicMobic approvalMobic escapes boxed warning.MOBIC - Brief Article

In the case of meloxicam, an NSAID, the FDA received more than 20 abbreviated new drug applications.
COPYRIGHT 2006 International Medical News Group
COPYRIGHT 2008 Gale, Cengage Learning

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MobicMobicMobic approvalMobic escapes boxed warning.MOBIC - Brief Article

(Food and Drug Administration, April, 2000)
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Concerns are being raised about some of the most commonly used medicines in Australia. The arthritis drug Vioxx was withdrawn from sale in 2004, because trials indicated an increased risk of heart attack and stroke, and the Therapeutic Goods Administration has said the same risks exist for people taking more than 200mg a day of the arthritis treatment Celebrex or more than 15mg a day of Mobic. The arthritis treatment diclofenac, often sold as Voltaren, has been associated with a 55 increase in the risk of heart …

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The approval of meloxicam was the result of a “cluster” review approach, one of the process improvements the FDA has instituted to facilitate the review of generic drug applications. The OGD has begun to review groups of applications submitted at the end of five-year new chemical entity (NCE) exclusivity in “clusters” to increase efficiency and decrease review time. At the expiration of five-year exclusivity, the FDA often receives multiple applications from different sponsors, submitted on the same day.
In the case of meloxicam, the OGD received more than 20 Abbreviated New Drug Applications (ANDAs), and efforts of the FDA’s review team resulted in approval of 13 generic applications for this product in a little over nine months of review time. This is the first time that any generic version of this product has been available.
Because all the patents have expired for Mobic, approval of meloxicam is likely to represent immediate savings to the American public. In 2005, Mobic was ranked 38th in dollar sales of brand-name drugs in the United States, with sales totaling $916,397,000, according to the online magazine, Drug Topics.
Generic drugs are used to fill more than 50 percent of all prescriptions. Because they can cost a fraction of the price of brand-name drugs, the economic impact of the FDA’s generic drug program is significant. With this in mind, the OGD continues working expeditiously to review and take action on generic drug applications.
COPYRIGHT 2006 U.S. Government Printing Office
COPYRIGHT 2008 Gale, Cengage Learning

Osteoarthritis (OA) of the knee is one of the most common causes of knee pain in people over the age of 30. The cause is progressive wearing away of the cartilage cushion that covers the ends of the long bones that make up the knee joint. The inflammation that accompanies this process leads to swelling and pain.

Risk factors include family history of osteoarthritis, trauma, misalignment of the knee (leg not being straight), and obesity. Initially the discomfort is described as stiffness in the knees after lying down or sitting. Going up and down stairs as well as getting into and out of a car may be difficult.

OA of the knee can also cause locking, clicking, and a “give-way” sensation in the knee.

Pain at night is also a sign of OA.

The diagnosis is established by careful history and physical examination. Physical findings include tenderness along the joint line, misalignment of the knee (either bow-legs or knock knees), and the presence of joint swelling. The hip should also be examined because hip arthritis can also cause knee pain.

Laboratory blood tests will often be ordered to rule out other causes of arthritis. In addition, the physician will often draw fluid off the knee to analyze it.

While x-rays may be ordered to determine the extent of cartilage wear, they may be normal early on in OA. Magnetic resonance imaging (MRI) is a much more sensitive method for detecting OA of the knee but is expensive.

Treatment of OA of the knee depends on the extent of symptoms. For mild pain, analgesics such as acetaminophen (Tylenol) may be sufficient. Stronger analgesics such as tramadol (Ultram) or propoxyphene (Darvon) may be more effective.

However, for those people who do not respond to acetaminophen or tramadol, the next option is low doses of non-steroidal anti-inflammatory drugs (NSAIDS). Examples of these drugs include ibuprofen (Advil), ketoprofen (Orudis) and naproxen (Aleve). These drugs may be purchased over the counter. More severe or persistent pain may require a prescription NSAID such as etodolac (Lodine), nabumetone (Relafen), dicloflenac (Voltaren), meloxicam (Mobic), and celecoxib (Celebrex). A note of caution: all NSAIDS have been associated with a slight increase in risk as far as cardiovascular events (heart attack and stroke) are concerned. They should be used with caution in patients who have a history of underlying heart disease. Also because of other reasons, they should be used with great caution in patients who have a history of ulcers or significant liver and kidney disease.

At the same time as medicines are introduced, a patient should be started on ice (ice packs) applied to the knee for 20 minutes twice a day. They should also start quadriceps setting (thigh muscle strengthening) exercises. These are exercises designed to strengthen the quadriceps muscles. The stronger these muscles are, the less pain a patient will experience.

Dietary supplements such as good quality forms of glucosamine and chondroitin may be helpful.

Injections of glucocorticoids (steroids) into the knee can be quite useful for symptomatic patients. Another type of injection- hyaluronic acid (Hyalgan, Supartz, Euflexxa, Orthovisc, Synvisc) may be indicated. Hyaluronic acid mimics the effects of the normal synovial fluid produced by the healthy knee. These injections reduce pain, provide lubrication, and may slow down the rate of cartilage deterioration.

Inserts in shoes may help with knee alignment issues and therefore can lead to pain relief.

Weight loss for patients who are obese is important. Low impact aerobic exercise (swimming, a stationary cycle, walking) accompanied by thigh strengthening and stretching are also effective for reducing pain.

Finally, braces and sleeves worn over the knee can also reduce pain that occurs with weight-bearing. Special types of braces that “unload” the part of the knee that is narrowed from arthritis can relieve symptoms in many patients.

Arthroscopy, which is a procedure where a small telescope is inserted into the knee and used to remove damaged or diseased tissue, is another potential option. Finally, patients who have pain that is associated with severe loss of cartilage from the knee may be candidates for knee replacement.

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Leading drugs used to treat rheumatoid arthritis include Amgen’s Enbrel, Centocor’s Remicade and Abbott’s Humira. According to IMS Health, only 10 percent of diagnosed patients are treated with one of these anti-TNF drugs, so growth within this class of drugs is expected to continue as physicians become more familiar with the drugs. IMS predicts that Enbrel and Humira will especially benefit from growth, as unlike Remicade, they are self-administered.
Sales of Remicade are therefore expected to slow down or decrease by 2010. According to 2005 figures, Enbrel (etanercept) is ranked 11th among the leading U.S. products in terms of sales, achieving sales of $2.7 billion and 36 percent growth. Remicade (infliximab) is ranked 20th, achieving sales of $2.2 billion and 12 percent growth.
Recent COX-2 withdrawals mean they are no longer among the top 10 leading classes of drugs and have thrown the prescription market for drugs to treat osteoarthritis, the more common form, into a tailspin–nothing has really stepped in to pick up the lost COX-2 dollars, suggesting that many people are living in discomfort. Even OTC pain relief has yet to see the lift many suppliers expected in the wake of the COX-2 troubles. In 2005, total sales of Bextra and Celebrex reached $1.76 billion compared with total COX-2 sales of $5.4 billion in 2004, when Vioxx was still on the market. Among traditional NSAIDs, Mobic was the top seller in 2005, achieving sales of $1.94 billion.
Anti-TNF drugs in the pipeline include UCB’s Cimzia (certolizumab pegol), which is expected to be approved for use to treat RA in 2007, and Centocor’s golimumab, which is in phase II trials for RA and has shown good clinical results, according to IMS.
In March this year, Roche received approval for the use of MabThera (Rituxan) in RA patients who fail to respond to anti-TNF therapy. The company has another potential RA drug, Actemra (tocilizumab), in phase HI trials. Also this year, Bristol Myers Squibb launched Orencia (abatacept), a T-cell co-stimulation modulator, for patients who fail to respond to other disease-modifying drugs, including methotrexate. Both Mabthera and Orencia are expected to reach blockbuster levels (in excess of $1 billion) in sales, according to IMS.
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COPYRIGHT 2008 Gale, Cengage Learning

As a practical matter, the best place to start will be to look at how it affects your pocketbook. The Medicare Prescription Drug plans will be offered by insurance companies and other private companies approved by Medicare, and these plans will offer at least the standard level of coverage which consists of the following:

- a monthly premium which will vary depending on the plan you choose.
- a $250 annual deductible, which is the first $250 of the annual cost of the drugs.
- a 25% co-pay for the next $2,000 in drug costs with the Medicare Prescription Drug plan paying the other 75% of these costs.
- There is also a coverage gap period, referred to as the “doughnut hole”, where the beneficiary pays 100% of the next $2,850 in drug costs.
- After that, the beneficiary has a 5% co-pay for the rest of the calendar year after the $3,600 in out-of-pocket costs.
Of all the features in the new Medicare Prescription Drug plan, the most confusing and probably the most controversial aspect appears to be this “doughnut hole” coverage gap period, where the beneficiary is responsible for not only 100% of the prescription drug costs, but also the monthly premium. And this is also why before enrolling in a plan, beneficiaries will want to crunch some numbers to determine which plan is best suited for their particular situation.

The first thing beneficiaries will need to consider is the drug formularies that they will be using during the year. Before deciding on a Medicare Prescription Drug plan, beneficiaries will want to confirm that their drug formularies are covered by that plan, and they will want to compare the co-pays that will be required for their particular drug formularies. The Medicare website has a useful tool for comparing the various prescription drug plans.

Here is an example of three Medicare Prescription Drug plans selected for comparison with the Prescription Drug Plan Finder tool found on the Medicare website, using the following assumptions:

- Beneficiary is adding coverage to the Original Medicare fee-for-service plan;
- is not eligible for additional help for people with low income;
- is a resident of Ellicott City, MD using the 21042 zip code;
- and uses three commonly prescribed drug formularies: Diovan (High Blood Pressure Angiotensin Blockers), Mobic (Anti-inflammatory NSAIDs) and Lipitor (High Cholesterol Statins)

The search result listed a total of 48 plans available to Medicare beneficiaries in the Ellicott City area. The Prescription Drug Plan Finder tool on the Medicare website allows for comparison of three plans at a time, and the results for the plans selected for comparison are below.

(1) AARP MedicareRx Plan (Contract ID: S5820, Plan ID: 004)
- Monthly premium $28.61 and $0.00 deductible
- Annual Total Drug Plan Cost to Beneficiaries - $1,756

(2) WellCare Signature (Contract ID: S5967, Plan ID: 039
- Monthly premium $19.80 and $0.00 deductible
- Annual Total Drug Plan Cost to Beneficiaries - $2,925

(3) Humana PDP Standard S5884-063 (Contract ID: S5884, Plan ID: 063)
- Monthly premium $6.44 and $250.00 deductible
- Annual Total Drug Plan Cost to Beneficiaries - $1,038

Only by comparing the prescription drug plans based on an individual’s specific drug formulary needs, can the consumers make an informed decision. As we can see from the above example, there are some significant differences on the annual total drug plan cost using our assumptions. As it turns out, the most important variable in determining the total annual drug plan costs to the beneficiaries are not the premium and deductible, but whether or not a particular drug formulary is covered under the plan. Another important variable is the amount of co-pay that the beneficiary has to pay for a particular drug formulary. The amount of co-pay that is required of the beneficiary will depend on which tier group a particular drug formulary is listed under by the prescription drug plan.

In our example, the AARP and the WellCare plans did not require an annual $250 deductible, but they varied in the level of coverage for our drug formularies. In the case of WellCare, the beneficiary would have had to pay 100% of the cost of the drugs (and also pay the monthly premium!) since this plan did not cover any of the three formularies, while the AARP plan covered the drugs but required a co-payment ranging from 40% for Lipitor to 66% for Mobic. The best plan in our example, the Humana Standard plan, had the lowest monthly premium and they also provided standard coverage for all three of our drugs, requiring just the 25% co-pay before reaching the initial coverage limit. All three of these plans had 6 local drug stores including CVS, Giant, RiteAid among others, conveniently located in the area that accepted their plans.

While the new Medicare Prescription Drug plan can be confusing, with a bit of research and some number crunching, consumers can make an informed decision. With the rising cost of healthcare and prescription drugs in general, the new Medicare Prescription Drug plan has the potential to be a positive new benefit for Medicare beneficiaries, and an important part of a personal financial plan. Keep in mind also that, you are not locked into a particular plan forever. After May 15, 2006 there will be an annual open enrollment period from November 15 through December 31 of each year when beneficiaries can change their plans.

OA affects weight-bearing joints such as the knee and hip. It is a disease of articular cartilage, the tough, elastic material that cushions moving parts of joints. OA is the most common reason for eventual total hip and total knee replacement surgery.

It has been felt that early diagnosis of this condition could potentially lead to earlier treatment.

To date, treatment for osteoarthritis has centered on pain relief only. To that end oral non-steroidal anti-inflammatory drugs (NSAIDS) such as ibuprofen (Motrin), aproxyn (Naprosyn), sulindac (Clinoril), piroxicam (Feldene), nabumetone (Relafen), etodolac (Lodine), ketoprofen (Orudis), meloxicam (Mobic), and celecoxib (Celebrex) have been used with varying degrees of success.

Along with these medicines, analgesic medicines such as acetaminophen (Tylenol), propoxyphene (Darvon), and tramadol (Ultram) have also been used to manage symptoms.

Other modalities such as physical therapy, braces, lateral wedge insoles inside shoe, arthroscopy (entering the joint with a small telescope to remove damaged and diseased tissue), injections of glucocorticoid (”cortisone”), and injections of lubricants, called viscosupplements, have also been used to alleviate symptoms.

Despite the mixed effectiveness these various treatments have had as far as pain control, they have not been completely successful.

The reason? The Holy Grail of OA treatment has been to identify treatments that can slow down and possibly reverse cartilage deterioration.

This is predicated on diagnosing the condition early. To date, diagnostic methods such as x-ray and magnetic resonance imaging (MRI) do not detect the disease until OA is in advanced stages when joint damage may already have occurred.

Arthroscopy can detect early disease but is not practical because of the invasive nature of the procedure.

A method for earlier diagnosis could open a window of opportunity for preventing or reducing permanent damage. Recent evidence suggests that dietary supplements like glucosamine/chondroitin might prevent further joint deterioration. A recent study demonstrating a new medical imaging technology may provide physicians with an accurate test for early diagnosis of OA, scientists from New York reported at the 236th National Meeting of the American Chemical Society

“Our methods have the potential of providing early warning signs for cartilage disorders like osteoarthritis, thus potentially avoiding surgery and physical therapy later on,” says Alexej Jerschow, Ph.D., who reported on the research jointly with Ravinder R. Regatte, Ph.D.

He adds, “Also, the effectiveness of early preventative drug therapies can be better assessed with these methods.”

Cartilage consists of collagen and proteoglycans. Proteoglycans are long chains of linked sugars and proteins.

The new method uses a modified form of magnetic resonance imaging to determine the concentration of a polymer known as glycosaminogycan (GAG), a proteoglycan that holds lots of water and gives cartilage its tough, elastic properties. GAG also is a recognized biomarker for osteoarthritis.

According to the scientists, a low concentration of GAG is known to correlate with the onset of osteoarthritis and other cartilage disorders.

The diagnostic test utilizes a method that “tags” the hydrogen atoms attached to the GAGs in a way that makes them emit a signal that can be picked up by an MRI machine to determine the concentration of GAG and assess cartilage status.

The advantage of such a test is not only to detect early OA but also to assess the effectiveness of newer disease-modifying osteoarthritis drugs (DMOADS), which are currently being studied by a number of companies.