AIT Becomes One of the First Labs in the Nation to Develop an Assay for Tapentadol

In late 2008, the FDA approved a new drug called tapentadol, which is prescribed by doctors for the relief of moderate to severe acute pain. Because the drug is so new, laboratories have not had tests in place to help doctors monitor patient compliance – until now.

AIT’s research and development team has been hard at work since July developing an assay for this new drug and is finally ready to begin accepting samples from clients.

Click here to access a PDF of AIT's test announcement for tapentadol. 

“We are one of the first labs in the nation to offer this testing,” said John Constantine, area sales director for the west. “This all began when the sales team heard that this drug might be a big player in the pain management arena, so we started the talks with the lab to get this underway.”

What does it take to develop a test for a new drug?

“It’s a long process,” said Joanna Askwith, research and development chemist, who has taken the lead on this project with the help of Technical Director Tim Dahn. “There are multiple aspects to an assay,” said Askwith. “The analyte (tapentadol) needs to be extracted from the matrix, an instrument method has to be developed for the desired analyte, and then methods for quantitation and analysis are created. Then we continue to develop and test the methods until they are suitable for finalization and production.”

Once the method was developed, the lab asked clients to send in samples from patients who were being treated with the drug to ensure the assay was robust and accurate.

According to Dahn, the process to develop the test for tapentadol has been more challenging than with other tests because of the lack of data and literature on the drug. “With other compounds, there is already published literature that shows things like metabolites,” he said. “In this case, the drug is so new so there just wasn’t information out there on it. This was a learn-as-you-go process for all of us.”

This process has not only allowed AIT to offer a new test for clients but also build stronger relationships with them as well. “We worked with our clients based on their needs and their willingness to send in samples to help develop this assay,” said Constantine. “This is also a great example of several AIT departments working together to provide ‘A Higher Standard of Service’ for our clients.”

The following is important information about AIT's test for tapentadol:

Trade Name
Nucynta

AIT Test Code
40660

CPT Code
82542

Clinical, Forensic Significance
Schedule II novel analgesic drug approved for the treatment of moderate to severe pain in patients 18 years of age or older. Effective as an agonist at the µ-opioid receptor sites and as a nor-epinephrine reuptake inhibitor. None of the metabolites of tapentadol are thought to be pharmacologically active. As an agonist at the µ-opioid receptor sites, overdose is typically treated with naloxone.

Specimen Type
Urine

Minimum Specimen Volume
5 mL

Method of Analysis
Liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS)

Limit of Quantification
10 ng/mL (confirmation only)

Excretion Characteristics
Undergoes extensive (97%) first-pass hepatic metabolism with approximately 99% renal excretion – 3% unchanged drug, 69% glucuronic acid conjugates, and the remainder as other metabolites. Approximately 95% of a single dose is excreted in the 24-hour urine. Complete (99.9%) excretion is noted to be within 5 days.

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About AIT Laboratories: 
AIT Laboratories, headquartered in Indianapolis, Ind., is an independent reference laboratory that is a premiere testing and research institution recognized nationwide for superior customer service and quality in testing. AIT specializes in pain management, forensics, clinical, and pharmaceutical testing. In 2008 and 2009, AIT was named one of the “Best Places to Work in Indiana” by the Indiana Chamber of Commerce. AIT has been recognized by Inc. magazine as one of the top 5,000 fastest-growing, private companies in the nation for the third consecutive year. Earlier this year, the Indiana Chamber of Commerce named AIT as the “Small Business of The Year.”