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The Gout Dugout.Issue #035.Krystexxa to lauch in December;gout drugs'shortages; RDEA594 is promising
November 12, 2010
Welcome to the mid November 2010 edition of the Gout Dugout newsletter. This is the catch-up issue because it fell behind schedule on account of my father's death in late September. The next edition, December 2010, will be despatched, as usual, in the first three days of December.
I know most Gout Dugout readers are looking for information on natural gout remedies, but some readers (and they will be those who suffer the most from gout) are interested in getting the latest news about new gout drugs. So here it is.
KRYSTEXXA'S DECEMBER LAUNCH - A CHRISTMAS PRESENT FOR SOME GOUT SUFFERERS.
Since the U.S. FDA approved Krystexxa in mid September, its developers, Savient Pharmaceuticals had been working on plans to bring both the product to market and sell their business. It was an unusual situation. Savient haven't as yet found a buyer for their business, but they did recently announce that Krystexxa will be available in the U.S.on 1 December 2010. They do realise they have a moral obligation to get their new gout drug to those who need it as soon as possible, and no doubt Wall Street will be pleased to see revenues beginning to come in, after all those development and cash burn years, from this virtually one product company.
The price of the Krystexxa treatment (infusions into an arm for around 2 hours every fortnight)still hasn't been announced. Savient are going to the wire on this but they say it will be when they begin U.S.distribution on 1 December. A 60 strong sales force will be recruited and trained by the end of January 2011 they think, and there will be a full Krystexxa launch in February.
So,if you live in the U.S. and you want Krystexxa(Pegloticase), talk to your primary care physician (G.P.), rheumatologist, nephrologist,(kidney specialist) or other health care professional now.
Savient also announced they will apply to the European Medicines Agency (EMEA) for Krystexxa approval in EU countries on 4 January 2011. But don't get excited. The EU approval process will take about a year. Just because it's been approved in the U.S. doesn't mean it will be in the EU, although U.S. approval means a lot. And even if the EMEA grants marketing approval, each EU country will then decide for itself. That will take at least another six months in faster decision making countries like Germany and Britain. If you live outside the U.S or E.U. the wait is going to be even longer than this. If only all those involved in the decision making process suffered from gout.....
GOUT DRUGS' SHORTAGES: USE THE INTERNET
A couple of months ago, a medication I need from time to time - Tranxene - for a muscle spasm, was out of stock at all the branches in the largest pharmaceutical retailer, and others, in the Philippines. After an inspired brainwave, and I wish I had more, I tracked down probably the only stock left in the country in the pharmacy of its newest and best hospital.
This hospital advertises itself as one of the best in the world. When you walk into its foyer (lobby) it feels more like a Hilton or Hyatt than a hospital, except for the staff wandering around in obviously medical uniforms. Maybe this is the way hospitals are heading: hotel look-alikes with medical care.
After I got my Tranxene I asked about gout medications. What did they have in stock, in one of the best hospitals in the world? There was a shortage of Benemid (probenecid), and the pharmacy staff hadn't heard of Febuxostat, Benzbromarone or Sulphinpyrazone. I wished I'd asked about Colchicine, and I will next time I visit.They did have Allopurinol of course (who doesn't). Even branded Allopurinol is cheap in the Philippines. But that's all they had. There wasn't any gout med that directly improves uric acid excretion, but the problem for a majority of gout sufferers is that they don't excrete it well, not that they over produce and so need Allopurinol.
First lesson from the story - If you have a similar dilemma get a prescription from a doctor, and buy on the Internet. Get used to buying your drugs overseas, if necessary and via authorised (authorized) websites. You may have to pay duty on the shipment,depending on your country's imports rules, but at least you'll have the medication and you'll know the score with your country's Customs dept. This is infinitely better than suffering because you can't get the gout med you need and maybe see your uric acid level rise more.
Second lesson - Learn as much as you can about gout so that you know all the options open to you.I think too many gouty folk think the only thing you can do is take Allopurinol.
Third lesson - You won't be tempted to take the wrong medication for your gout, just because it's available.
All this is especially true if you don't live in a well managed country where medication shortages are unknown or very rare.
Such shortages are not confined only to the Philippines of course. www.medicalnewstoday.com recently carried a story about drug shortages, this past year, in of all places, the U.S. although they didn't mention any gout meds.
Read this story here.
RDEA594 FOR GOUT - DOING WELL
RDEA594 is one of a cluster of new gout drugs under development.The only thing that really matters with a gout drug, apart from all the safety considerations, is how well it can reduce the uric acid level since this is the key to the control of future gout attacks, and clearing up tophi.
The medications that encourage its excretion seem to be usually better in lowering uric acid than those that inhibit its production. Krystexxa (pegloticase), Benzbromarone (not available in many countries) and Probenecid have all demonstrated this.
RDEA594 is one that also encourages its excretion. A recent new and interesting trend, it seems to me, is to test drugs that encourage excretion together with those that inhibit its production (trialists take both) to see if they perform better together.
The developers of RDEA594 for gout recently announced results of clinical studies of RDEA594 + Febuxostat and RDEA594 + Allopurinol. In both cases the results were better than Febuxostat or Allopurinol alone. Its best result was 400 mg of RDEA594 in the second week, and 600 mg of RDEA594 in the third week together with 80 mg of Febuxostat. This combination reduced uric acid (UA) below 4.0 mg/dL in all participants from a median starting level of 10.4 mg/dL. And over half the trialists at this dosage got UA below 3.0 mg/dL, and some, intraday,down to 2.0 mg/dL.That is really cheery news. Below 4.0 mg/dL is the sort of level where tophi would be cleared up or shrink.
And there were some good results with RDEA + Allopurinol, better than taking Allopurinol alone.
RDEA594 is still some years away from possible approval, but if it's approved for use with other gout drugs these numbers mean it might compete with Krystexxa. And because it's taken orally it may
well be much cheaper.No serious adverse events or people going off trial were judged to have been caused by RDEA594 or by its combination with the two others. Studies will continue.
FREE pH FOODS CHART AND RECIPES
Many diets are capable of getting the uric acid level down. One is an alkaline (pH) diet. If you want a free pH food chart with 45 alkalizing recipes, click on this link to phionbalance.com and when the home page arrives, the download link for the chart is on the right. You can then print out the food chart, so that you can take it with you when you go shopping for food.
John Mepham BA.(Econ).
P.S. You may distribute this newsletter freely and free-of-charge, providing any links in it remain unchanged and it remains intact. Partial copying is not allowed.
NB. The contents of this newsletter contain medical information, not medical advice. Please always discuss gout remedies with a doctor, or other health care professional, before implementing any treatment.
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