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Date: Sep 02 2009

Lifetree Clinical Research® presents new prescription drug abuse study findings to pain medicine industry
FOR IMMEDIATE RELEASE:  February 9, 2009
Press Contact:  Therese Clay 801.541.9244



LIFETREE CLINICAL RESEARCH® PRESENTS NEW PRESCRIPTION DRUG ABUSE STUDY FINDINGS TO PAIN MEDICINE INDUSTRY
New study shows that drug concentration and time are both important in assessing abuse potential

SALT LAKE CITY---  Lifetree Clinical Research®, one of the largest specialized clinical research organizations in the Western region of the United States, recently presented new findings regarding pharmacological factors with opioid formulations that appear to drive prescription drug abuse.  The study was designed to aid in prescription drug abuse research and is the first study to explore ratios of blood concentration and the speed to which its various formulations reach the maximum blood concentrations (Cmax) on the "euphoric” and "liking” effects following oral oxycodone dosing.  Dr. Lynn R. Webster, medical director of Lifetree Clinical Research® & Pain Clinic, presented the data at the American Academy of Pain Medicines’ 25th conference in Honolulu, Hawaii Jan. 27 – 31.  Lifetree Clinical Research® received a grant to conduct the study from King Pharmaceuticals, Inc., a vertically integrated branded pharmaceutical company headquartered in Bristol, Tennessee.

The primary objective of the study was to evaluate the relationship between the pharmacokinetics (the study of the bodily absorption, distribution, metabolism and excretion of drugs) of oral oxycodone and the pharmacodynamic endpoints, which are specific measures of abuse-liability in opioid-experienced, non-dependent, recreational drug users.  This is the first study to show the relationship between oxycodone "liking” and "euphoria” to the speed of onset and maximum drug concentration over a clinically relevant range of doses. Basic science research has shown that the abuse potential of an opioid is related to its maximum blood concentration (Cmax) and how quickly this level is reached (Tmax), but the relative importance of each has never been investigated in humans.  This study explored various ratios of Cmax/Tmax on the "liking” and "euphoria” of oxycodone formulations. The ratio of Cmax/Tmax is called the Abuse Quotient (AQ).

"This study is critically important for those in industry trying to develop opioid formulations less likely to be abused,” said Webster.  "Although only preliminary, this study provides very useful information on what appears to be major pharmacologic factors that influence abuse”

The study researchers concluded that if "liking” and "euphoria” effects drive oxycodone abuse, then an AQ value may help determine the abuse potential of opioid formulations.  A high AQ value may help identify preferred drugs and formulations sought by recreational prescription drug abusers. Conversely a low AQ value may suggest less attractiveness as a drug of abuse.  Webster said, "Research is needed to determine if indeed this construct will hold true over time and with other opioids and classes of compounds at risk for abuse, misuse, and diversion.”

"Prescription opioid abuse is a serious problem that has attracted much attention in recent years,” Webster stated.  "Despite the prevalence of oxycodone abuse, there is little information in the public domain regarding what motivates someone to choose one drug over another.  New abuse-resistant drug formulations, whose purpose is to prevent a user from feeling the effects of opioids rapidly, are being studied and may be one of the ways to curtail the abuse and diversion of prescription opioids while ensuring their availability for patients who benefit from their use.  These new abuse deterrent formulations may help reduce the epidemic of abuse while providing a medication that will be effective in treating intractable pain."
     



MORE ABOUT LIFETREE CLINICAL RESEARCH®:
Lifetree Clinical Research® is a privately-held company, headquartered in Salt Lake City, Utah.  Lifetree’s clinicians are recognized clinical and regulatory thought leaders in protocol design, implementation and oversight.  Lifetree is dedicated to supporting the pharmaceutical, device, and biotechnology industries by providing unparalleled service and becoming an indispensable drug development partner.  For more detailed information about Lifetree Clinical Research®, please visit www.lifetreeresearch.com.    


 
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