New Gout Drug Krystexxa Exceeds Target
September 2, 2011 by Alex.
There is increased hope for the roughly 3% of chronic, severe gout sufferers who do not respond to current gout medications. In recent phase III trials of the new gout medication Krystexxa, an impressive 42% of refractory gout patients achieved statistically significant reductions in uric acid levels, and sustained them for six months. This exceeeded the target amount set for the study by the drug's manufacturer, Savient Pharmaceuticals. In contrast, those 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 is pretty good," said Dr. Michael Becker from the University of Chicago," author of the latest 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) was 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 deposits in the joints, usually at the base of the big toe. The uric acid can also form knobby, chalky lumps called tophi. Tophi can be reabsorbed back into the body if uric acid levels are reduced. Forty percent of the trial participants with tophi experienced a resolution of one or more of the lumpy deposits.
Krystexxa is given intravenously over at least 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 to the treatment could eventually use cheaper gout medications.
Armed with these impressive new results, Savient Pharmaceuticals plans to amp up promotion of its new gout drug in the US and other countries. Up to now, their marketing efforts have largely been aimed at rheumatologists, but they now plan to expand their efforts to include primary care physicians. "This really now is the foundation for our launch of phase 2 into the primary care audience," said Savient Chief Executive Officer John Johnson.
Johnson says the pharmaceutical company "expects to see some acceleration in sales" as a result of their increased target market. The company is said to be disappointed in the $1.4 million dollars in net sales the gout medication generated in the first six months after receiving FDA approval.
Filed under: Gout Medications.
Tags: gout drug, krystexxa, gout medication, generic plegloticase, gout cause, gout tophi, side effects of krystexxa, generic allopurinal, zyloprim, colchicine, colcrys.
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