Dominion develops and validates clinical quantitative assays for tapentadol

Sep 15 2009

Dominion Diagnostics (Dominion) has recently developed and validated one of the first clinical quantitative assays for the drug tapentadol (Nucynta(TM)) performed by liquid chromatography/tandem mass spectrometry (LC/MS/MS). Tapentadol, recently approved for use by the FDA, is a centrally-active analgesic that has demonstrated efficacy in pain relief with improved gastrointestinal tolerability compared to other opioids for pain management.

Dominion's new assay by LC/MS/MS can detect and identify the primary drug tapentadol. Tapentadol is extensively metabolized in humans. In clinical studies 97% of the administered dose was metabolized, with 70% of the dose excreted in the urine in the conjugated form (55% as tapentadol-O-glucuronide and 15% and tapentadol-O-sulfate). Tapentadol excretion is almost exclusively renal. In a clinical study, it was shown that greater than 95% of a single dose of tapentadol was excreted in the urine within 24 hours of oral administration(1).

"This is a noteworthy achievement for our Research & Development (R&D) and Laboratory Teams," stated Chief Operating Officer Stephen Jordan. "Dominion has invested considerable time and resources in developing this new tapentadol assay. Providing assays for new pain medications allows us to better support our clients' need for relevant and accurate technologies when relying on urine drug monitoring to support patient adherence."

Dominion's quantitative tapentadol assay, one of the first presented to the industry, is now available to all clients across the country. This new development comes as part of Dominion's continued commitment to unparalleled laboratory excellence. Dominion continues to lead the industry in its quest for accurate, clinically relevant science for use in appropriately monitoring chronic pain patients. Dominion's R&D team actively works with leading assay manufacturers and pharmaceutical companies to develop accurate, specific tests that meet current and future needs of the growing pain management industry.

"Our LC/MS/MS assay for tapentadol is highly sensitive and offers clinicians an accurate means of detecting tapentadol in patients that are prescribed the drug, patients that may be diverting their medications, or in other cases where a patient may have been provided the drug from other sources," Dominion's Director of Research & Development Matthew Woodcock, Ph.D. commented. "At Dominion, we recognize the important clinical implications of urine drug monitoring, and we pride ourselves on offering scientifically accurate solutions to support every clinical scenario."