By Ron Shinkman, Editor, Laboratory Industry Report
Millennium Health has secured a contract from the U.S. Food and Drug Administration to provide urine drug testing, consultation and research collaboration for an upcoming clinical trial.
The trial will focus on the effects of the long-term exposure to time-release opioid painkillers and whether they heighten a user’s sensitivity to pain, and will help develop more specific guidelines regarding tolerance for such drugs and the risk assessment of each patient. About 3,300 patients will be screened for potential participation in the trial, which will be randomized, double-blind and placebo-controlled, comparing the discontinuation of opioid drugs versus ongoing treatment. The contract is worth as much as $1.6 million, according to Millennium officials.
Deaths from prescription opioid painkillers have quadrupled since 1999, according to data from the U.S. Centers for Disease Control and Prevention, including 16,000 fatalities in 2013.
“Long term opioid treatment can produce positive outcomes when prescribed and used appropriately, but they also carry risks that must be managed. Urinary drug testing plays a critical role in aiding the clinician in evaluating patient safety. Millennium’s selection as a service partner in this important initiative reflects our advanced technical and analytic capabilities and commitment to excellence," said Millennium Chief Executive Officer Brock Hardaway in a statement.