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 them for six months. This exceeeded the target amount set for the study by the drug's manufacturer, Savient Pharmaceuticals. In comparison, individuals gout patients in the trial that received a placebo saw no reduction in uric acid levels.
When you have 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 newest study, which was published in the Journal of the American Medical Association. "Gout can be a sincere about and disabling disease."
Krystexxa (generic name plegloticase) has been FDA approved in 2010 based on earlier clinical trials. The new 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 the Cause of Gout, an Extremely Painful Form of Arthritis
The excess acid crystallizes into needle sharp debris in the joints, usually at the foot 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 participants with tophi skilled a resolution of one or more of the lumpy deposits.
Krystexxa Emerged Intravenously Over a Minimum of Two Hours Every Two Weeks
The Fda 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 amazing new results, Savient Pharmaceuticals intends to amp up advertising 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 now is the foundation for our launch of stage 2 into the primary care audience," said Savient Chief Executive Officer John Johnson.
Johnson says the pharmaceutical company "expects to see a few speed inside sales" as a result of their increased target market. The business is said to be disappointed in the $1.4 thousand us dollars in net sales the gout treatment generated in the first six months after receiving Fda approval.
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