New Medicine for osteoarthritis, by Dr. Humeira Badsha, Rheumatologist, Dubai, UAE

NicOx SA has filed a New Drug Application (NDA) for the first in a new class of anti-inflammatory agents, the CINODs (cyclooxygenase-inhibiting nitric oxide donators). The new drug, naproxcinod, is intended for the relief of the signs and symptoms of osteoarthritis (OA).

NicOx also expected to seek European approval for Naproxcinod

The NDA request is based on data from three large pivotal phase 3 studies in more than 2700 patients with knee or hip OA. All 3 studies met their co-primary efficacy endpoints (the WOMAC pain subscale, the WOMAC function subscale and subject's overall rating of the disease status). The company plans also to seek European Medicines Agency (EMEA) approval in Q4 2009.

Michele Garufi, Chairman and CEO of NicOx, declared, "The submission of a New Drug Application is a tremendous achievement for any company and represents a particularly important milestone for NicOx. This accomplishment represents another major step in NicOx's planned transformation into a self-sustainable pharmaceutical company, able to make significant contributions to the successful commercialization of naproxcinod. To achieve this key corporate goal, we continue to focus on building NicOx's future commercial operations in the US."

No untoward blood pressure effects seen with naproxcinod

The phase 3 assessments of naproxcinod's blood pressure profile, as well as 3 randomized, controlled clinical pharmacology studies in a total of 548 subjects, all found that the drug was well tolerated.

Pascal Pfister, Chief Scientific Officer and Head of Research & Development at NicOx, said, "To our knowledge, naproxcinod is the first New Chemical Entity anti-inflammatory to be submitted to the FDA for OA since the withdrawal of the COX-2 inhibitors rofecoxib and valdecoxib and we believe it could become an important treatment option for patients with OA. We would like to congratulate our whole Research & Development department on the submission of this high quality NDA, which includes extensive data on naproxcinod's efficacy, safety and tolerability, collected in more than 4,000 patients. We look forward to submitting a Marketing Authorization Application to the European authorities within the end of the year."

30 % of Back pain patients recover within a year. Article posted by Dr. Humeira Badsha, Rheumatologist, Dubai, UAE

A third of patients may completely recover from chronic lower back pain by 9 months, according to a BMJ study.

Researchers enrolled some 400 patients who presented to general practitioners, physiotherapists, or chiropractors soon after experiencing low back pain and who had persistent pain at 3 months. The patients were followed for 1 year. By 9 months, some 35% had fully recovered (i.e., they were pain-free, had no back-related disability, and had fully returned to work), and by 12 months, 41% had.

The following groups were at increased risk for delayed recovery: those with previous sick leave related to low back pain, high disability levels at enrollment, lower education levels, and a higher perceived risk for persistent pain.

Link(s):
BMJ article (Free) http://click.jwatch.org/cts/click?q=227%3B67291090%3BTwT0Ho0B0jeunokFTBFf4qznfZCd4J%2F1IKrXW7GcEu8%3D

New Treatment for Osteoarthritis.

The osteoporosis drug teriparatide (Forteo) stopped and even reversed cartilage loss in a mouse model of osteoarthritis," according to University of Rochester researchers. During the study, they severed the "medial collateral ligament in the legs of mice, which quickly leads to degeneration of cartilage in the affected joints -- much as similar injuries in human knees eventually induce osteoarthritis." After some eight weeks, "cartilage area was reduced about 20 percent, compared with mice given a sham surgery." Then, the injured mice received either "teriparatide or placebo immediately, continuing treatment for 12 weeks." By trial end, "teriparatide was associated with 20 to 27 percent more joint cartilage than in placebo-treated mice." The team was even more intrigued by the "mice who did not start drug treatment until eight weeks after the injury." Those mice "had 31 to 35 percent more cartilage at study week 12 (four weeks after starting treatment) than placebo-treated mice."

Fasting and your arthritis.

During the holy month of Ramadan, Muslims including those with arthritis will fast from sunrise to sunset. There has been some evidence of the benefits of fasting and detoxification diets helping arthritis. However, some general precautions should be adhered to. For patients with arthritis, it is always wise to check with your Rheumatologist as to whether you can continue to fast and take medications which may be immune suppressants, or irritant to the stomach. Also the timing of your medications may vary during Ramadan and hence check with your doctor. If you have gout avoid red meats and shellfish. With all forms of arthritis a healthy, balanced diet is helpful. It is important during Ramadan to make sure one does not get dehydrated so take at least 8 -10 glasses of water between iftar and suhoor. Dehydration can be especially bad for those with gout or high uric acid levels, those with multiple medicines for rheumatoid arthritis, or anyone with kidney problems due to lupus. Fruit juices can be consumed in moderation. In fact pineapples contain an enzyme bromelain, which is useful for arthritis. Cherry juice may be helpful for gout. Oily fish or omega or fish oil supplements, ginger, garlic, turmeric, soya bean, avocadoes are some foods which are helpful. Remember to get 1000 mg of calcium from dairy products (1 glass of low fat milk has 290 mg of calcium, 1 cup of yogurt has 250 mg) and enough vitamin D through sun exposure, or else take a calcium supplement with vitamin D. Exercise in moderation. If exercising during fasting it may be wise to reduce your usual exercise duration and intensity by 30%, and be sure to warm up and cool down. Fasting during Ramadan can have many health and spiritual benefits. The Emirates Arthritis Foundation and doctors at Dubai Bone and Joint Center wish you a happy and peaceful holy month.

Study of arthritis in the Emirates

The Emirates Foundation, Abu Dhabi, has awarded the

Emirates Arthritis Foundation a grant of AED 250,000.00 towards research



The welcome funding received from The Emirates Foundation has been allocated to assist with the study of Rheumatoid Arthritis in patients of Arab ancestry. This important research will result in a nationwide database of Rheumatoid Arthritis patients and will help to ascertain the need for financial support, disability and workplace assistance. From this information, EAF will be able to provide relevant assistance to people who most need it.

Rheumatoid Arthritis is a painful disease causing inflammation in the joints. It occurs in patients of all ages, but most prominently in women after the age of 25.

Emirates Arthritis Foundation formed under the patronage of Her Royal Highness Princess Haya Bint Al Hussein

Early Treatment for Rheumatoid Arthritis. Posted Aug 10, Dubai, United Arab Emirates

Investigators say TNF blockers may benefit certain patients with early RA.
HealthDay (8/6, Preidt) reported, "Patients with early rheumatoid arthritis (RA) who respond poorly to standard treatment with methotrexate may benefit from additional treatment with tumor necrosis factor (TNF) blockers," according to a Swedish study published in The Lancet. "Previous research has shown that 20 to 40 percent of patients have a good response to methotrexate therapy and don't need more intensive combination treatment." Aiming to find a way to help the remaining percentage, researchers looked to "487 patients with early RA (less than one year's duration) who were initially treated with methotrexate." Some three to four months after treatment started, "the 258 patients with an inadequate response to methotrexate were randomly assigned to receive either the TNF blocker infliximib (Remicade) or the conventional disease-modifying antirheumatic drugs [DMARDs], sulfasalazine and hydroxychloroquine."
According to WebMD (8/6, Hitti), "one year later, 39 percent of the patients taking methotrexate plus Remicade had only low levels of RA symptoms, compared to 25 percent of patients taking methotrexate plus sulfasalazine and hydroxychloroquine." Lead investigator R.F. van Vollenhoven, MD, was quick to point out that the "difference between the two groups didn't happen right away; the Remicade-plus-methotrexate group took the lead after six months of treatment." Nevertheless, "the researchers aren't recommending anti-TNF drugs for everyone with RA, because anti-TNF drugs are more expensive than conventional drugs and aren't always needed or appropriate."
MedPage Today (8/6, Gever) quoted the authors, "In patients with early rheumatoid arthritis in whom methotrexate treatment failed, addition of a tumor necrosis factor antagonist to methotrexate monotherapy is clinically superior to addition of conventional disease-modifying antirheumatic drugs." The authors of an accompanying editorial, however, "argued that the study should not be interpreted as showing that infliximab is superior to oral DMARDs as the proper partner with methotrexate." In fact, "they noted that a statistical advantage can be found for biologic agents, even though only 20 percent of patients with suboptimal response to methotrexate do better on them." In other words, "the most important information to be gathered from clinical trials in rheumatoid arthritis is not necessarily comparisons of agents, but rather the strategy of tight control, aiming for remission."

New medicine for Osteoporosis in breast cancer patients.Dr. Humeira Badsha, Consultant Rheumatologist Dubai, United Arab Emirates

Amgen says denosumab met goals in late-stage study.
The AP (8/4) reports, "Biotechnology company Amgen Inc. said Monday its drug denosumab met the goals of a late-stage study in treating patients with cancer that has spread to their bones." For the trial, researchers "compared denosumab and" Novartis AG's "Zometa [zoledronic acid] in the treatment of bone metastases in 1,776 advanced cancer patients." Amgen reported that "the two drugs had similar effects in delaying the length of time until a patient's first bone injury and subsequent bone injuries."

The trial also showed that "the time to a subsequent event, the secondary endpoint, was also better than Zometa's, though not by a statistically significant amount," Dow Jones Newswires (8/4, Gryta) reports. Currently, "the US Food and Drug Administration is also reviewing denosumab as a treatment for osteoporosis and bone loss caused by hormone treatment in patients with breast and prostate cancer."

Reuters (8/4, Berkrot) reports that the trial is the second of three planned studies testing the drug in patients with cancer that has spread to their bones. According to Amgen, full details of the trial are expected to be presented at a future medical meeting.