Millennium Laboratories Announces Five Drug Screening Tests to Help Pain Physicians with Therapeutic Patient Care.

Greater Sensitivity, Accuracy and Specificity with Millennium's New LC-MS/MS Assays Can Detect and Identify Drug Abuse and Diversion

SAN DIEGO -- Millennium Laboratories, a leading provider of therapeutic drug monitoring and education to physicians and staff treating chronic pain patients, announced today the company's development and validation of a clinical quantitative assay for the new drug tapentadol (Nucynta[TM]) by liquid chromatography/tandem mass spectrometry (LC-MS/MS). In addition, the company now offers drug screening tests for heroin metabolite 6-Monoacetylmorphine, alcohol biomarkers ethyl glucuronide (EtG) and ethyl sulfate (EtS), and meperidine (Demerol[R]).

Nucynta is the first new centrally-acting analgesic approved in the United States in 25 years. It is considered to have the potency of morphine with reduced side effects. The drug's presence or absence in a patient can now be detected by LC-MS/MS technology, providing a tool to pain physicians for optimal prescribing.

National pain management expert Dr. Joseph Shurman, Chairman of Pain Management at Scripps Memorial Hospital, La Jolla, California, commented, "With new opioids like tapentadol being introduced, pain physicians need to avail themselves of the latest cutting-edge technology for routine drug screening of their patients. The DEA has mandated that physicians must do their best to demonstrate that their patients are compliant, that they are taking what they are prescribed and are not diverting the drugs. For the health of the patient and for the safety of the patient and the physician's practice, fast and accurate drug screening results are critical."

6-Monoacetylmorphine (6-MAM, heroin metabolite), has been added to Millennium Laboratories' offering due to the increase in the US population's use of heroin. Due to the epidemic of non-medical use of Oxycontin[R], heroin use has increased dramatically even though it has no medical utility. Oxycontin can be powerfully addictive because the body quickly develops a tolerance to it. Oxycontin abusers soon gravitate to heroin for its similar high but much lower price tag. Recent research has shown that 6-MAM can be present in urine when morphine, the traditional metabolite looked for in the urine screening process, is absent. By adding the 6-MAM assay, a higher percentage of heroin users can be detected.

Alcohol biomarkers ethyl glucuronide (EtG) and ethyl sulfate (EtS) positively detect and confirm patient alcohol use. Alcohol consumption by pain patients may present a real threat to their treatment, invoke physiological harm to the patient, and/or suggest to the physician that the patient possesses addiction tendencies. Physicians managing patients on central nervous system suppressants must monitor patient alcohol abuse due to the catastrophic and potentially fatal complications of mixing alcohol with these medications. Ethyl glucuronide has been identified as an important biomarker for alcohol ingestion primarily due to its extended detection window (up to 5 days after heavy ethanol consumption) and sensitivity to measurement by mass spectrometry(1). Alcohol can also modify the metabolic pathways for specific medications such as drug absorption and elimination, amplifying the need for absolute confirmation for patients taking pain medications.

Meperidine (Demerol[R]) is a narcotic analgesic prescribed for the relief of moderate to severe pain which is highly addictive when used long-term and can cause psychological and physical dependence. The abuse of meperidine poses a risk of overdose and death.

LC-MS/MS technology provides greater assay sensitivity and specificity so that in addition to identifying a patient's prescribed pain medications, physicians can also help identify patients who may be diverting their medications; patients who may have obtained drugs from other sources; and patients who may be using alcohol or illegal drugs with their prescription medications.

James Slattery, CEO of Millennium Laboratories, said, "We are very proud of our laboratory team who quickly and reliably provide scientifically valid and legally defensible drug screening results for original drug compounds, drug metabolites or illicit substances. Our resources and research are geared toward providing our physician network with the most innovative technologies to help them deliver the best treatment and therapies to their patients."

About Millennium Laboratories

Founded in 2007 in America's biotech capital, San Diego, Millennium Laboratories is rapidly becoming the Urine Drug Testing (UDT) resource of choice for physicians and staff focused on the treatment of chronic pain. Millennium Laboratories provides the fastest turn-around time in the industry for drug test reporting and confirmation of results because the company is the only major Urine Testing Laboratory exclusively utilizing the latest cutting-edge technology Liquid Chromatography/Mass Spectrometry/Mass Spectrometry (LC-MS/MS). The company is the only major Urine Drug Testing Laboratory licensed as a training facility for Toxicologist Scientists.

Certified, state-of-the-art advanced training at Millennium's 40,000 sq. ft. campus is an integral component of the University of California, San Diego's (UCSD) doctoral program in Pharmacy. Led by Laboratory Director Amadeo Pesce, Ph.D., world-renowned Toxicologist and author, the Millennium Laboratories team are experts in mass spectrometry and high throughput chemistry. The company has developed proprietary methodologies that provide the fastest reliable urine drug testing (UDT) confirmations in the nation, usually within one business day. For more information, visit the Millennium Laboratories website, www.becausepainmatters.com

Reference:

1. Wurst FM, Skipper GE, Weinmann W. Ethyl Glucuronide -The Direct Ethanol Metabolite on the Threshold from Science to Routine Use. Addiction. 2003; 98 (suppl. 2): 51 - 61.

Nucynta[TM] is a registered trademark of Ortho-McNeil[R], Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.

Oxycontin[R] is a registered trademark of Purdue Pharma, L.P.

Demerol[R] is a registered trademark of the Sanofi-Aventis Group.