12/8/2009
FACTS ABOUT COLCRYS® (COLCHICINE, USP) TABLETS AND UNAPPROVED DRUGS
The first and only single ingredient colchicine product approved by the FDA
- COLCRYS® is the first and only single-ingredient colchicine to be approved by the FDA for the prophylaxis and treatment of gout flares. Other colchicine products currently on the market have never been approved by the FDA. Unapproved drugs do not conform to current standards of quality, purity or potency and can pose a significant risk to patients.
- Unapproved colchicine products are sometimes incorrectly referred to as “generic” colchicine. In reality, there are no generic equivalents of COLCRYS.
- COLCRYS was approved for the treatment of acute gout flares on July 30, 2009; approved for the prophylaxis of gout flares on Oct 16, 2009; and approved for Familial Mediterranean Fever (FMF) on July 30, 2009.
- No scientific studies have been conducted on unapproved colchicine products to prove their safety or efficacy. Therefore, critical information that is routinely available for FDA-approved products – including correct information on safety and effectiveness, tolerability, dangerous side effects and interactions with other medicines – cannot be determined for unapproved colchicine.
- URL Pharma conducted the research and made discoveries that enable the appropriate use of colchicine, resulting in FDA-approved COLCRYS. The AGREE study, a Phase III clinical trial conducted by URL Pharma partnering with several leading rheumatologist investigators, demonstrated that colchicine can be given at lower doses than traditionally prescribed, avoiding serious gastrointestinal side effects while retaining effectiveness.
- Researchers also made important findings about commonly-used drugs that may have serious and potentially fatal interactions, providing the medical community with extensive guidance on how to safely administer colchicine with other medications such as those taken for hypertension, infectious disease (antibiotics) and HIV/AIDS.
- URL Pharma’s research and subsequent FDA approval of its New Drug Application (NDA) for COLCRYS aligns with an initiative the FDA launched in 2006 to bring unapproved products under its regulatory framework by requesting that manufacturers conduct studies to demonstrate safety and efficacy of unapproved products. The initiative also grants FDA the authority to remove untested, unapproved products from the market.
- More information about the FDA’s initiative on unapproved drugs, the risks of unapproved colchicine, and the benefits of Colcrys® are available via the following links: