224E Tapentadol abuse: the first 18 months

Wednesday, October 24, 2012
Westin Diplomat Resort
Richard C. Dart, MD, PhD1, Edgar H. Adams, Sc.D.2, Becki B. Bucher-Bartelson, PhD1, Gary M. Baker, Pharm.D.3, Janet K. Pitner, Pharm.D., MBA3 and Gary J. Vorsanger, PhD, MD3
1Rocky Mountain Poison and Drug Center, Denver, CO
2Covance Market Access, Gaithersburg, MD
3Janssen Scientific Affairs, LLC, Raritan, NJ

Purpose: Prescription opioid analgesics play an important role in the management of moderate to severe pain.  An unintended consequence of these agents is the nonmedical use of prescription pain relievers.  In 2008, nonmedical use of pain relievers among persons aged 12 years or older was second only to marijuana in the U.S.  We describe the rates of abuse, misuse, and diversion of tapentadol immediate release [Nucynta®, CII], for the 18 months following launch in 2009.

Methods: The RADARS® System measures rates of abuse, misuse and diversion throughout the U.S.  Data from the Drug Diversion, Survey of Key Informants (SKIP), Poison Center, and Opioid Treatment Programs were analyzed to compare rates for tapentadol with other opioid analgesics from June 2009 through December 2010, utilizing both per 100,000 population (POP) and per 1,000 Unique Recipients of Dispensed Drug (URDD) as denominators.

Results: Based on data from the SKIP program from June 2009 to December 2010, non-medical use rates for tapentadol fluctuated between 0 and 0.572 per 1,000 people who filled a prescription (URDD) and 0 and 0.015 per 100,000 population (POP), reflecting non-significant changes over time (p=0.816 and p=0.867, respectively).  Data from Poison Centers, Outpatient Treatment Programs, and Drug Diversion programs also showed similar non-significant trends in population and exposure rates (all p-values >0.05) during the observation period.

Conclusion: Since product launch, rates of abuse, misuse, and diversion of tapentadol have been low; however, continued monitoring of trends in the data are warranted.