Big Mountain Drugs Helps Victims of Shocking Gout Drug Price Hike
Concerned that older drugs that have been in use since before the inception of a stringent approval process in the 1960’s may not meet current standards for safety, effectiveness, quality and labeling, the Food and Drug Administration (FDA) launched the Unapproved Drug Initiative in 2006.
Under this initiative, the consumer protection agency ordered pharmaceutical companies manufacturing unapproved drugs to either undergo rigorous and expensive clinical trials to obtain approval for the drugs, or to remove them from the market. In return, those companies winning approval would be given exclusive market rights for a time period, to allow them to recoup their investment.
Among the many older commonly prescribed gout relief drugs that have never gone through the formal FDA review and approval process are morphine, phenobarbital, nitroglycerine, and the gout medication colchicine. Colchicine has been widely used in many countries since the 1930’s, and won FDA approval in combination with a second gout medication, probenicid, in the early 1980’s, but has never been approved as a single ingredient medication.
One of over twenty US pharmaceutical companies manufacturing generic colchicine, URL Pharma, successfully underwent the rigorous approval process and received exclusive rights to market its brand name colchicine, Colcrys, in 2009. The FDA awarded URL Pharma exclusive rights to market colchicine for gout for three years, and for familial Mediterranean fever for seven years. In 2010, all other American pharmaceutical companies were ordered to stop manufacturing the gout drug within 45 days, and to stop shipping it within 90 days.
The price of one colchicine tablet soared from 9 cents to almost $5, a move that is projected to increase state Medicaid costs for the gout drug from $1 million to $50 million. The response was a public outcry, including pointed queries to URL Pharma from a number of Members of Congress. URL Pharma has expanded its patient assistance and co-pay programs to allow price breaks for those in need of the gout medication who were hardest hit by the immense price hike, but still faces a great deal of public criticism.
The American College of Rheumatology (ACR) was one of the organizations that protested the steep increase as unjustified. The ACR encouraged other pharmaceutical companies to enter the market with their own branded version of colchicine, and announced in 2010 that at least one other manufacturer would be seeking FDA approval.
New Gout Medicine Doing Well In Test Trials
A new gout medicine known as Ilaris continues to be confirmed as successful in lowering patients’ pain and reducing the chance of new gout attacks, and has already applied for approval to be used in the U.S., according to Novartis.
Ilaris contains a compound known as ACZ885 which is shown in two different scientific studies to give superior gout pain relief and lessen the chance of new attacks in gout patients by as much as 68 percent. Novartis said the studies showed more than 450 patients taking Ilaris, or ACZ885, had less pain and the risk of new attacks were reduced by up to 68 percent compared to those taking an injectable steroid to treat gouty arthritis attacks, which can last for a week or more.
According to Novartis, the monoclonal antibody in Ilaris blocks an inflammatory protein called interleukin-1 beta
. The drug has been filed for approval in the European Union, U.S., Canada and Switzerland. The drug is already approved in several countries to treat a rare, inflammatory disorder known as Cryopyrin-Associated Periodic Syndromes (CAPS).
“We are very excited about these results, which indicate that ACZ885 may become a significant new alternative for gouty arthritis patients
,” said David Epstein, head of the pharmaceuticals division at Novartis, as quoted by Fox News. Gouty arthritis, or gout, affects about 1.4 percent of the population in the U.K. and 3.9 percent in the U.S.