New Gout Drug Krystexxa Exceeds Target
There is increased hope for the roughly 3% of chronic, severe gout sufferers who do not respond to current gout medications. Within recent period III trials of the new gout medication Krystexxa, a great impressive 42% of refractory gout patients achieved statistically significant reductions in uric acid levels, as well as sustained all of them for six months. This exceeeded the target amount set for the study by the drug's manufacturer, Savient Pharmaceuticals. Compared, individuals gout patients in the trial that received a placebo saw no reduction in uric acid levels.
When you've seriously ill people who have no options, 40 percent will be pretty good," said Dr. Michael Becker from the University of Chicago," author of the most recent study, which was published in the Journal of the American Medical Association. "Gout can be a really serious and disabling disease."
Krystexxa (generic name plegloticase) had been FDA approved in 2010 based on earlier clinical trials. The newest gout medication, which is administered by intravenous infusion, is derived from an animal hormone. The pegloticase mechanism of action is different than that of other gout drugs - it converts uric acid to a nontoxic byproduct that is easily excreted in the urine.
- High levels of uric acid are usually the cause of gout, an extremely painful form of arthritis.
- The excess acid crystallizes into filling device sharp build up in the joints, usually at the base of the big toe.
- The actual uric acid can also form knobby, chalky mounds called tophi.
- Tophi can be reabsorbed back into the body if uric acid levels are reduced.
- Forty percent of the trial members with tophi experienced a resolution of one or more of the lumpy deposits.
Krystexxa is Given Intravenously Over a Minimum of Two Hours Every Two Weeks
The Food has warned that patients should be given a corticosteroid and antihistamine before infusions because of a high risk of allergic reaction. Other common side effects of Krystexxa are gout flare ups (which occurred in 80% of the recent trial participants), nausea and vomiting, chest pain, constipation, nasal irritation and bruising at the injection site.
Krystexxa is not intended for use in the average gouty arthritis patient, most of which can be treated with more traditional gout medications such as Colcrys (generic colchicine) or Zyloprim (generic allopurinal). Currently, the new injectable gout drug costs about $5000 a month. It's hoped that gout patients who respond well in order to the treatment could ultimately use cheaper gout medicines.
Armed with these extraordinary new results, Savient Pharmaceuticals plans to amp up promotion of its new gout drug in the US and other countries. Up to now, their advertising efforts have largely been aimed at rheumatologists, but they now plan to expand their own efforts to include primary care physicians. "This really today is the foundation for our launch of phase 2 in to the primary care audience," said Savient Chief Executive Officer John Johnson.
Johnson says the pharmaceutical company "expects to see several velocity inside sales" as a result of their increased target market. The organization is said to be disappointed in the $1.4 million us dollars in net sales the gout medication generated in the first six months after receiving Food approval.
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