It was starting to look like 2009 was the year going banner year for new gout drugs. That all came to a holt on Sunday as the FDA rejected the application for Savient Pharmaceuticals, Inc.’s drug, Krystexxa® (also called puricase or pegloticase). This new drug used an enzyme not found in humans that breaks down uric acid in the body. To prevent the body rejecting the foreign enzyme it is “locked up” in a molecular “cage”. This cage allowed uric acid to flow in but blocks the immune system from attacking the enzyme (see, New Gout Drugs – Coming to a Pharmacy Near You).
Interestingly, the FDA did not have any complaints about the drug itself and found that the drug was safe and effective. In fact, the FDA’s advisory board voted 14 to 1 to approve the drug. However, the FDA raised concerns that the drug that was studied was created using a different manufacturing process than the drug that would be released to the public. Due to concerns that this different manufacturing process could change the safety or effectiveness of the drug, the FDA rejected the drug until the manufacturer proves that the different manufacturing method resulted in a drug that was also safe and effective.
Savient Pharmaceuticals intends to resubmit this drug for approval again early next year. Unfortunately, this means that this drug will not be approved for at least another year or more.
The drug that was approved
The FDA did approve one new drug for gout this past week however: colchicine. Despite being using to treat various ailments, including gout for over 2000 years, colchicine was finally approved by the FDA for use in gout treatment and will be sold under the brand name colcrys® by Mutual Pharmaceutical Company.
The real good news here is that the FDA has also updated its dosing recommendations. Instead of the normal dosing of two tablet at the onset of gout symptoms and one every hour until diarrhea occurs, the FDA required a dosing study be done as part of the approval process. This study found that a single dose at the onset of pain and one additional dose, one hour later was just as effective as the once an hour method and resulted in far fewer side effects. This is an even lower dose than many gout experts are currently recommending (see, The Most Misused Gout Drug: Colchicine).
This is great news for those that use colchicine for gout attacks. Not only has a formal study been conducted to verify that this dosing is effective but the FDA will now be issuing guidance to doctors to prescribe the lower dose. This means that far fewer people will be suffering the painful and embarrassing side effects of colchicine!
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