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Osteoarthritis

Study Shows ZyCal's Cyplexinol Decreases Pain and Stiffness and Increases Quality of Life for Osteoarthritis Patients

cyplonex

Today, ZyCal Bioceuticals, Inc announced positive results of the first double-blind, placebo-controlled study evaluating Cyplexinol for alleviating symptoms for patients with osteoarthritis.

According to the study, patients receiving Cyplexinol had a significant decrease in pain and stiffness and a significant increase in quality of life compared to those receiving the placebo. Results from the study were published in the peer-reviewed, April/May 2013 issue of Integrative Medicine: A Clinician’s Journal.

Cyplexinol consists of bone morphogenetic proteins (BMPs), which stimulate bone and cartilage growth and fight inflammation. The naturally-derived, biologically active protein complex Cyplexinol is the active ingredient in ZyCal’s Ostinol, which is currently available as an oral supplement through the company as well as through Chiropractors and Naturopathic physicians without a prescription.

“Using BMPs to rebuild cartilage and down-regulate inflammatory pathways is a new and exciting approach to managing the debilitating symptoms of osteoarthritis,” Richard Garian, DC, CCSP, one of the study investigators and co-authors of the paper stated. “For the first time, using rigorous study methods, we were able to demonstrate significant and measurable improvements in pain relief, functionality and quality of life in patients treated with an oral BMP – complex, Cyplexinol in as little as one week.”

The study consisted of 87 patients with moderate-to-severe osteoarthritis who had joint pain in a weight-bearing joint. Participants received a daily dose of either 150 mg of Cyplexinol or placebo for 12 weeks. Pain, stiffness, and quality of life were the three primary endpoints that were measured using the Western Ontario and McMaster University (WOMAC) Osteoarthritis Index 3.1.

Results showed that at week 12, patients receiving Cyplexinol had an improvement (decrease) in pain by 3.35 points versus 0.35 for patients receiving the placebo, improvement (decrease) in stiffness by 2.95 points versus 0.18, and improvement (increase) in quality of life by 3.12 points versus 0.40 points.

“The ability of bone morphogenetic proteins (BMPs) to stimulate bone and cartilage growth is well-documented in peer-reviewed literature and for decades, orthopedic surgeons have used BMPs intra-operatively to treat patients with bone-healing difficulties,” James Scaffidi, President and CEO of ZyCal Bioceuticals, Inc. said in a statement. “In creating Cyplexinol, the first oral BMP – complex, we are able to bring the benefits of BMPs to the millions of people suffering from debilitating bone and joint conditions.”

Source: ZyCal Bioceuticals, Inc.

Last Updated: 4/10/13; 12:30PM EST

Evidence Presented Linking Obesity with Osteoarthritis

ors

Recent research presented at the Orthopaedic Research Society’s (ORS) Annual Meeting in San Antonio, Texas suggested that obesity may be linked to osteoarthritis.

Osteoarthritis is a condition that causes the break-down of cartilage in the joints. This condition affects millions of adults and can be very painful and debilitating. It is widely accepted that overweight individuals are at higher risk for developing the condition due to extra weight placed on the joints; however new evidence suggests that certain biomolecules may be linked to osteoarthritis.

Investigators James Nishimuta and Marc Levenston from the Mechanical Engineering Department at Stanford University in California have been studying the effects of adipokines, biomolecules produced by fat tissue, on osteoarthritis.

“Over the past decade, we have learned that adipokines at high levels have been linked to many obesity-related health problems such as cardiovascular disease and diabetes. In our study, we examined how adipokines can contribute to the breakdown of joint tissues. In particular, we wanted to see if the effects on cartilage and meniscus are different,” Nishmuta explained in a statement.

The investigators found that the meniscus is much more sensitive to tissue breakdown induced by adipokines than cartilage. They are working together to determine if this combination of high force and adipokines have any interaction in the breakdown of tissue. This evidence could lead to novel, biologic pathways that could help with detection of osteoarthritis, as well as with therapeutic intervention.

The ORS 2013 Annual Meeting will continue throughout tomorrow, “Bridging Innovation”.

 

Source: Orthopaedic Research Society

Last Updated: 1/28/13; 3:20PM EST

Watson’s Generic Arthritis Drug Receives ANDA

Watson

Watson Pharmaceuticals Inc recently announced that their subsidiary, Watson Laboratories Inc., received United States Food and Drug Administration (FDA) approval on its Abbreviated New Drug Application (ANDA) for the generic version of their osteoarthritis and rheumatoid arthritis drug.

The Diplofenac Sodium and Misoprostol Delayed-Release Tablets are the generic equivalent to G.D. Searle’s Arthrotec for patients who are at high risk for ulcers when treated with non-steroidal anti-inflammatory drugs (NSAIDs) used to treat arthritis and pain.

According to IMS Health data, Arthrotec had sales in the US of approximately $130 million for the past year, ending on May 31, 2012.

The company plans to start selling the generic drug during the fourth quarter 2012.

About Watson Pharmaceuticals, Inc.

Watson Pharmaceuticals, Inc is an integrated global specialty pharmaceutical company. The Company is engaged in the development, manufacturing, marketing and distribution of generic pharmaceuticals and specialized branded pharmaceutical products focused on Urology and Women's Health. Watson has operations in many of the World's established and growing international markets.

Source: Watson Pharmaceuticals Inc.

Last Updated: 7/12/12; 11:50am EST

Liver Injury Linked to Arthritis Medication

Limbrel

(Reuters Health) - A "medical food" sold as an arthritis treatment may have caused four cases of temporary liver damage, researchers reported Monday.

The product in question is called flavocoxid, sold under the brand-name Limbrel. It's a mix of plant compounds called flavonoids, including catechins -- substances best known as components of green tea.

Limbrel is considered a medical food, which makes it different from a dietary supplement. It is available by prescription only, to treat osteoarthritis -- the common, "wear-and-tear" form of arthritis caused by cartilage breakdown in the joints.

But medical foods are different from prescription drugs in that they don't have to be proven safe and effective before hitting the market.

In the new report, published in the Annals of Internal Medicine, researchers describe four cases in which Limbrel users developed temporary liver "injury."

That meant symptoms like abdominal pain, jaundice (yellowing of the skin), intensely itchy skin and fever.

All of the patients recovered after they stopped using the product.

The researchers cannot say with certainty that all four cases were caused by Limbrel.

"There's no single test you can do to say, ‘Bingo, it's caused by this,'" said lead researcher Dr. Naga Chalasani, of Indiana University School of Medicine in Indianapolis.

But he said that three of the cases were "highly likely" to have been caused by Limbrel. The fourth was "possibly" caused by the product.

Timing was a big clue. All four patients developed signs of liver toxicity within three months of starting the arthritis treatment. And all got better within three to 12 weeks of stopping it.

That relatively quick recovery is the good news, Chalasani said. "It seems like you stop taking it, and the liver injury improves pretty quickly, in a matter of weeks."

Scottsdale, Arizona-based Primus Pharmaceuticals, which makes Limbrel, did not return calls seeking a comment.

The four liver-damage cases turned up as part of an ongoing surveillance study of liver injury caused by drugs or herbal supplements. Between 2004 and 2010, researchers at several U.S. medical centers enrolled 877 patients who were thought to have liver damage from a medication or supplement.

Four of those cases were linked to Limbrel.

It's not fully clear why the product would damage the liver.

"That's the million-dollar question," Chalasani said.

But he and his colleagues suspect it may be the catechin content. Green tea extracts, which contain high concentrations of catechins, have been linked to liver toxicity.

Even if catechins are to blame, that still leaves the question of why only certain Limbrel users would develop liver problems. "There has to also be some kind of susceptibility" to liver injury, Chalasani said, noting that it could be a genetic vulnerability.

Also unclear is how many Limbrel users out there may have suffered liver injury.

Besides the four cases in this report, Primus has gotten eight reports of "clinically apparent" liver toxicity that the company shared with Chalasani's team.

The product is not widely used. Worldwide, it seems that about 400,000 prescriptions have been written for Limbrel, Chalasani noted.

He suggested that if you are one of those users, you should pay attention to any potential signs of liver toxicity, like abdominal pain and jaundice. "If you develop symptoms, stop using it and talk to your doctor," Chalasani said.

But an editorial published with the study says that people should be discouraged from using Limbrel -- and other dietary supplements marketed for arthritis.

Other anti-arthritis supplements include chondroitin and glucosamine, and there is little evidence they work, write Drs. Stephan Reichenbach and Peter Juni of the University of Bern, in Switzerland.

In the U.S., supplements and medical foods are not subject to the same regulation as drugs. That is, manufacturers can market them without showing proof to the Food and Drug Administration that the products work.

"Given the widespread use and potential harm of medical food and food supplements, the policy of marketing these products in the absence of clinical evidence may need to be reconsidered," Reichenbach and Juni write.

Unfortunately for arthritis sufferers, few treatments that are both safe and effective exist, the researchers point out.

Simple steps, like exercise and an occasional dose of acetaminophen, might help people with mild arthritis. But once the pain gets more severe, options are limited.

Some people find relief by regularly taking painkillers called non-steroidal anti-inflammatory drugs (NSAIDs) -- which include naproxen, ibuprofen and the prescription drug celecoxib (Celebrex).

But those drugs can cause stomach irritation and ulcers, and studies have linked them to an increased risk of heart attack.

Anti-inflammatory cortisone shots can help some people temporarily, but they are not a long-term fix. And the effectiveness of another option -- injections of joint-lubricating hyaluronic acid -- has been seriously questioned.

Chalasani said that people should choose their arthritis treatment after a careful discussion with their doctor. When it comes to dietary supplements, he said, don't assume they are completely safe simply because they are described as "natural."

SOURCE: bit.ly/N0G6LY Annals of Internal Medicine, June 19, 2012.

Uric Acid May Increase Likelihood Of Severe Osteoarthritis

osteoarthritisThe 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.

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