Best Evidence Analyses and Commentary

Accessibility of Abuse Deterrent Formulations
Yevgeniy Lyutov, PharmD Candidate; Mitchelle Rodriguez, PharmD Candidate; Katherine Tromp, PharmD
04/30/13

Prescription drug abuse is the intentional use of a medication without a prescription, in a way other than as prescribed, or for the experience or feeling it causes.1 Prescription drug misuse can consists of using a medication in a manner or at a dose that was not recommended by a healthcare professional.2 The misuse and abuse of prescription drugs is a growing epidemic in the United States. It is estimated that over 20% of Americans have abused prescription drugs.3

The National Institute on Drug Abuse (NIDA) reports the most commonly abused medications are pain relievers, tranquilizers, stimulants, and sedatives. They also state that among these medications, pain relievers are the most frequently abused prescription drug. The CDC reported 1 in 20 US individuals have used painkillers for non-medical use in 2010.4

Among adolescents, prescription and over-the-counter medications account for most of the commonly abused illicit drugs. The 2011 Monitoring the Future Study (MTF) from NIDA and National Institute of Health (NIH) showed that 1 in 12 high school seniors reported nonmedical use of Vicodin®; 1 in 20 reported abuse of OxyContin®. They also reported that when high school students were asked how prescription narcotics were obtained for nonmedical use, 70% of 12th graders said they were given to them by a friend or relative.6

Prescription opioid analgesics are an important component of pain management. Abuse and misuse of these products, however, have created a serious and growing public health problem. As a result of this growing drug problem, the Food and Drug Administration (FDA) and several drug companies have taken on the task of formulating abuse deterrent formulations for opioids, the most commonly abused painkillers.

In January 2013, the FDA issued a draft guidance document that is meant to assist industry in developing new formulations of opioid drugs with abuse-deterrent properties. Abuse deterrent formulations (ADFs) should mitigate abuse liability, reduce dependence potential, and decrease public health risk. In the guidance document from the FDA they have categorized abuse-deterrent formulations based on the mechanism by which they deter abuse (see Table 1).7 In recent years, several products have gained, are in the process of achieving or have attempted approval from FDA.

Overall, the development of opioids that are formulated to deter abuse is a step in the right direction. The use of ADFs in the management of chronic pain has the potential to curb the growing abuse of opioids but in order to truly make a difference; these products must be readily available. The recent guidance document released by FDA is meant to help generic drug companies meet the requirements brand name ADFs do.

There are various obstacles that ADFs need to overcome, including availability and efficacy. The majority of the ADFs are still in the approval process, have failed to prove they deter abuse, or have been taken off the market (voluntarily or mandated) [Table 2]. ADFs have demonstrated abuse deterrent capacity theoretically but lack clinical evidence supporting their abuse deterring properties. ADFs also face the availability of less expensive, more bioavailable opioids. Additionally, ADFs have not been able to deter the most common form of abuse, swallowing a number of intact pills or tablets to achieve a feeling of euphoria. Due to the pharmacologic nature of opioid analgesics and their need for the management of pain, the extent to which an abuse-deterrent product is able to reduce abuse will never be absolute.

 

 

 

 

References

 

  1. Topics in Brief: Prescription Drug Abuse. National Institute on Drug Abuse. 2011. Accessed March 11, 2013. http://www.drugabuse.gov/publications/topics-in-brief/prescription-drug-abuse
  2. Klein M. Combating Misuse and Abuse of Prescription Drugs. FDA Consumer Updates. 2010. Accessed March 17, 2013. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm220112.htm          
  3. Substance Abuse and Mental Health Services Administration, Results from the 2010 National Survey on Drug Use and Health: Summary of National Findings, NSDUH Series H-41, HHS Publication No. (SMA) 11-4658. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2011.
  4. The Centers for Disease Control and Prevention. http://www.cdc.gov/
  5. Hahn C, McPherson M, Rubingh C. Pharmacotherapy for pain management: new treatment approaches. American Pharmacist Association. Sept 2008 http://apha.imirus.com/Mpowered/imirus.jsp?volume=ptpi08&issue=1&page=6
  6. Johnston, L. D., O'Malley, P. M., Bachman, J. G., & Schulenberg, J. E. (2012). Monitoring the Future national survey results on drug use, 1975-2011. Volume I: Secondary school students. Ann Arbor: Institute for Social Research, The University of Michigan, 760.
  7. Guidance for Industry Abuse-Deterrent Opioids - Evaluation and Labeling; 2013. US Food and Drug Administration. 2013. Accessed March 12, 2013. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM334743.pdf
  8. Remoxy. DURECT Corporation product information. 2013. Accessed March 13, 2013. http://www.durect.com/wt/durect/page_name/remoxy
  9. Acurox® Briefing Information for a Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee. Food and Drug Administration. 2010. Accessed march 13, 2013. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndLifeSupportDrugsAdvisoryCommittee/UCM209143.pdf
  10. Alpharma Pharmaceuticals LLC: NDA 22-321 ALO-01 (Morphine Sulfate Extended-Release with Sequestered Naltrexone Hydrochloride) Capsules. 2008. Accessed March 13, 2008. http://www.fda.gov/ohrms/dockets/ac/08/briefing/2008-4395b2-02-ALPHARMA.pdf
  11.  Probuphine® Titan Pharmaceuticals, Inc. 2013. Accessed March 18, 2013. http://www.titanpharm.com/products.htm
  12. NRP290. New River Pharmaceuticals. 2004. Accessed March 18, 2013. http://www.nrpharma.com/products/NRP290.htm
  13. Remoxy. Pain Therapeutics. Accessed March 19, 2013. http://investor.paintrials.com/releasedetail.cfm?ReleaseID=587311
  14.  Oxecta. Accessed March 19, 2013
  15. Oxytrex. Pain Therapeutics. Accessed March 19, 2013. http://investor.paintrials.com/releasedetail.cfm?ReleaseID=297331
  16. Embeda. Enforcement Report for May 11, 2011. FDA. 2011. Accessed March 19, 2013. http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm255019.htm
  17. Talwin Nx in:Perform Rx Drug Information Update. 2010. Accessed March 19, 2013. http://www.performrx.com/drug_updates/Drug_Information_Update_Jan_10.pdf
  18. Suboxone. FDA Apporved Products. Accessed March 19, 2013. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails

 

 


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