Myths and Facts | URL Pharma

Correcting the Record: Separating Myth from Fact

Below are the most commonly repeated inaccurate or misleading statements about COLCRYS®, followed by the key facts that refute each of these myths:

MYTH:

“URL Pharma didn’t do any new research on COLCRYS.”

FACTS:

URL Pharma is the only company to have undertaken the significant research effort necessary to better understand colchicine and elevate it to modern-day standards of safety and efficacy.
The literature shows that there are 254 published clinical trials with colchicine, but that number is misleading. Out of all those trials, only one was a double-blind, placebo-controlled study — which is the accepted scientific standard for clinical trials – and that one involved only 43 patients. Our AGREE study is the only double-blind placebo-controlled study in acute gout that looked at a range of doses to determine the safest and most effective approach.
URL Pharma conducted 17 clinical studies that revealed important new discoveries about how doctors should dose colchicine to ensure that it’s being used safely and appropriately.
Important information that is routinely available for any FDA-approved product – including information on safety and efficacy, tolerability, dangerous side effects and interactions with other medicines – simply did not exist for colchicine until we conducted the research and made discoveries that enhance the safe use of colchicine. Otherwise healthy patients with an acute gout attack taking FDA approved COLCRYS are instructed to take 3 tablets then stop. If the same patient read the package insert of a non-FDA approved colchicine product, they would be instructed to take up to 16 tablets per day.
We discovered that colchicine may cause potentially fatal interactions with some commonly prescribed medications such as antibiotics and hypertension drugs, and our COLCRYS label gives doctors guidance on how to adjust the colchicine dosing to avoid these serious interactions. This critically important information was not known before we conducted our research.
Our AGREE trial is the largest clinical trial of its kind ever conducted in acute gout. AGREE demonstrated that a 3-tablet, 1-hour dosing regimen using the COLCRYS formulation was just as effective as the high doses traditionally used, while avoiding most of the risks of serious toxicities associated with high-dose colchicine.
Before our COLCRYS research program, there was no scientific basis for the guidance physicians were being given on how to dose colchicine. Several non-FDA approved manufacturers recommend that doctors give patients up to 16 tablets of colchicine to treat a gout flare which is more than 5 times the FDA-approved safe dose.
Our AGREE trial was a big step forward in understanding how colchicine should be used by doctors. The Colcrys dose we studied in AGREE was just as effective but far safer and more tolerable than high-dose colchicine. Among patients receiving the high dose, 77 percent experienced diarrhea; the level of diarrhea in patients receiving the COLCRYS dosing regimen was statistically no different than placebo. Severe adverse reactions dropped from 19 percent in the high-dose group to zero in the group of patients receiving the COLCRYS dose. These discoveries are significant advancements for the health and safety of millions of patients who have traditionally received unnecessarily toxic dosages of unapproved colchicine.

MYTH:

“Colchicine is a generic product.”

FACTS:

There is no such thing as “generic colchicine.” Generic products have been tested to ensure that they are equivalent to the branded pharmaceutical products and have been approved by the FDA as safe and effective. None of the single-ingredient colchicine products currently on the market have been by approved by the FDA, except for COLCRYS.
Calling unapproved colchicine products “generic” may provide a false sense of security that these products are safe and effective. No scientific studies have been conducted on unapproved colchicine products to prove their safety and efficacy.

MYTH:

“Unapproved colchicine has been used for centuries, so it must be safe.”

FACTS:

It’s incorrect to assume that unapproved colchicine must be safe because it’s been around so long. It’s an assumption that may put patients at significant risk.

The FDA reports that unapproved colchicine has been associated with 169 deaths; 60 of those deaths were due to dangerous interactions between unapproved colchicine and a commonly-prescribed antibiotic.

The prescribing information for unapproved colchicine products recommends doses that are far higher than necessary and highly toxic. Nearly all patients who take unapproved colchicine products unnecessarily endure adverse effects.

Current guidance on using colchicine is based on information that is outdated and not scientifically rigorous. In fact, current rheumatology textbooks (e.g.: Hellmann D. Chapter 67. Imboden J, Hellmann D, Stone J, editors. Current Rheumatology and Treatment, Second Edition. New York City: The McGraw-Hill Companies, Inc.; 2007) used in medical schools teach that colchicine should be given to patients every hour until they develop diarrhea. Giving patients such high does is medically unnecessary and potentially dangerous but this was not known until the discoveries from our AGREE trial.

The American College of Rheumatology does not have official guidelines on how to dose colchicine to treat a gout flare. The discoveries from our AGREE trial will help millions of people avoid unnecessary toxicities and adverse reactions.

Unapproved colchicine products have never undergone FDA review for safety or efficacy, so there is no assurance that these products conform to the same standards as FDA-approved products.

There are no assurances that unapproved colchicine products meet the FDA’s standards of purity or consistency from tablet to tablet. We don’t know if these products contain too much or too little medicine, or if they are free from impurities. COLCRYS® must meet extensive FDA controls.

Individual experience doesn’t prove a product is safe as evidenced by the fact that FDA reported169 deaths associated with unapproved colchicine use. Only scientifically rigorous studies, such as the ones we have conducted for COLCRYS, can determine if a drug is safe. The letter from FDA regarding unapproved colchicine states this (HHS Response Letter Regarding Concerns Over Current Market Prices of Approved Oral Colchicine,” Janet Woodcock, Director, Center for Drug Evaluation and Research (March 3, 2010)).

MYTH:

“Patients can’t afford COLCRYS.”

FACTS:

Our Patient Assistance and Co-Pay Assistance programs have ensured that patients who need Colcrys are able to access it, regardless of their economic status.

Our Patient Assistance Program is one of the most generous programs ever offered by a pharmaceutical company. Under the program, uninsured and Medicare Part D patients with household incomes of up to three times the federal poverty level (up to $66,000 per year for a family of four) can receive Colcrys free of charge. Uninsured and Medicare Part D patients with household incomes between three to four times the federal poverty level (up to $88,000 per year for a family of four) can receive Colcrys for $5 a month. Uninsured and Medicare Part D patients with household incomes between four to six times the federal poverty level (up to $132,000 per year for a family of four) can receive Colcrys for $25 a month.

Our Co-Pay Assistance program enables many patients who have health insurance to obtain COLCRYS for no more than $25 a month.

MYTH:

“The benefit offered by COLCRYS isn’t worth the price.”

FACTS:

When considering the benefit and value of a medication, the human cost has to be weighed alongside the economic cost. The human cost of unapproved colchicine – unnecessary and serious side effects, potentially dangerous drug interaction, toxicities, and the risk of death – is too high a cost to bear.

Shouldn’t the 169 deaths associated with unapproved colchicine, as reported by the FDA, be taken into consideration when discussing the cost of enhancing the safety of a product?

Avoiding adverse drug reactions helps the healthcare system, and society, avoid tremendous cost burdens, ranging from additional medical treatments to hospitalizations to lost productivity. Most people who take unapproved colchicine for gout flares have adverse events. In one published study, 100% of patients had at least one adverse reaction to treatment with unapproved colchicine.