Colcrys Approval Triggers Questions

“There are over 16,000 articles on Pub Med for colchicine, with 254 indexed as clinical trials,” says Dr. Fudman. “Doing one trial in patients and a few drug interaction studies doesn’t justify marketing exclusivity and a 50-fold increase in price.”

Others pointed to URL Pharma’s use of previously published trials to support the effectiveness of Colcrys in submissions to the FDA. “These studies were not done with the current formulation of Colcrys,” says Chris Morris, MD, a rheumatologist in private practice in Kingsport, Tenn. “They used information that, by their own definition, was gained using unapproved and illegal medications.”

In response to these issues, URL Pharma noted that only one earlier study was double-blinded and placebo-controlled, and only URL conducted a blinded/controlled dose ranging study. Previous trials were the only available alternative for the FMF indication because it would be unethical to place patients needing colchicine on a placebo.

Dr. Morris notes that Colcrys is one of two new medications for gout approved last year. The company making febuxostat (Uloric) paid for the initial development of the molecule, as well as doing phase 1, 2, and 3 trials. In addition, their phase 3 trial included two three-year extensions. Yet Uloric costs around $120 a month and Colcrys, taken twice a day for FMF or chronic gout, costs nearly $300.

Acute Gout Focus

The research focus on acute gout only was another concern expressed by the rheumatologists interviewed here. “While the company tried to focus on acute gout, the money is in gout prophylaxis and other chronic uses of colchicine that aren’t on the FDA label,” says Dr. Fudman. “There is no way they would recoup the expense of their trials selling three tablets for a gout attack. The money is in one to two tablets daily for a long time.”

Susan Hoch, MD, a rheumatologist at the University of Pennsylvania in Philadelphia, supports this view. “Even though few rheumatologists use colchicine for acute gout, URL was able to get the [other] makers of colchicine to leave the market. As a result, patients taking colchicine chronically for gout, pseudogout, and FMF will have only the expensive Colcrys available, even though it was not studied in those conditions.”