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Zorvolex for joint pain -- anyone tried it?

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#1 sthira

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Posted 24 September 2014 - 11:56 PM


http://www.arthritis...4240.1411602034


New Low-dose NSAID Approved

Lower dose could mean fewer side effects but long-term data is lacking.

09/05/2014 | By Jennifer Davis

The U.S. Food and Drug Administration (FDA) has expanded the use of a new version of diclofenac to manage osteoarthritis (OA) pain. Zorvolex, available only by prescription, is a low-dose nonsteroidal anti-inflammatory (NSAID). It has been on the market since October 2013, when it was first approved to treat mild to moderate acute pain in adults.

Zorvolex was designed to address growing concerns about the potentially fatal side effects of all NSAIDs – particularly the increased risk of cardiovascular and gastrointestinal (GI) problems, including heart attack, stroke, GI bleeding, GI ulceration and GI perforation. Because these risks go up with higher doses (and longer use), the FDA advises using the lowest dose for the shortest duration possible to achieve patient treatment goals.

The distinguishing feature of Zorvolex is its formulation of the active ingredient diclofenac. It is made up of “submicron” particles that are about 20 times smaller than those other NSAIDs. The drug’s manufacturer, Iroko Pharmaceuticals of Philadelphia, says that translates to better absorption, allowing for a lower dose to be used.

“The dose of diclofenac in Zorvolex is approximately 20 percent lower compared to the approved diclofenac product that company used as a comparator in the studies, and accordingly, there is an approximately 20 percent lower systemic exposure to diclofenac with Zorvolex,” explains Sharon Hertz, the FDA’s Deputy Director, Division of Anesthesia, Analgesia, and Addiction Products.

The recommended dosage of Zorvolex for OA pain is 35 mg three times a day (105 mg per day) compared to as much as 200 mg per day with other dicolfenac products.

“The effectiveness has been exactly the same, which is really interesting because it is much smaller doses,” explains Roy Altman, MD, a professor of medicine in the Division of Rheumatology and Immunology at the University of California, Los Angeles. Dr. Altman, has worked with Iroko for many years as a paid lecturer; he also reviews data, protocols and the research of co-authors. “In theory, it does reduce side effects because you are using a smaller dose,” Dr. Altman says.

But that’s in theory, so far. The FDA stresses there have not been any studies to show that Zorvolex reduces the cardiovascular and GI side effects associated with NSAIDs simply because it involves a lower dose. “We do not know if the dose reduction is sufficient to result in a difference because the company has not conducted any head-to-head safety studies with any other diclofenac product,” Hertz explains.

So for now, all NSAIDs, including Zorvolex, must carry warnings for the increased risk of cardiovascular and GI events.

#2 niner

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Posted 25 September 2014 - 01:18 AM

Boy, it doesn't seem like they've done much to demonstrate that it's better than non-micronized diclofenac.  I suppose it hits Cmax more rapidly, although diclofenac is known to be absorbed quickly.   If it's not too expensive, I suppose it's worth a try.



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#3 idquest

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Posted 18 October 2014 - 04:04 AM

Diclofenac was really bad on my stomach. It triggered the whole chain of very unpleasant consequenses. Eventually I treated the original problem with help of an acupuncturist and the bunch of side effects by drastic change in diet and with supplements.







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