Abuse-deterrent formulations (ADFs) help address unintentional misuse

The FDA has urged the development of opioids formulated specifically to encourage proper use1

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Abuse-deterrent formulations (ADFs) help address unintentional misuse

The FDA has urged the development of opioids formulated specifically to encourage proper use1

  • The FDA issued an updated Guidance for Industry in April 2015 to assist pharmaceutical companies in developing drug products with abuse-deterrent properties1
  • Since 2010, several opioids with ADF technology have been approved by the FDA, and more are in development2
  • It is important to understand the characteristics of these ADFs to help optimize chronic pain management2

Types of ADFs1

Physical barriers hinder the release of drug when chewed, crushed, cut, grated, or grinded. Chemical barriers resist extraction of drug with common solvents, such as water, alcohol, or other organic solvents
An opioid antagonist can be added to interfere with, reduce, or defeat the euphoria associated with abuse. It can only be released upon manipulation of the product
Combining substances to produce an unpleasant effect if the dosage form is manipulated or a higher dose than directed is used
Alternative methods of drug delivery that offer resistance to abuse
Properties could include the need for slower penetration into the central nervous system, enzymatic activation, different receptor binding profiles, or other novel effects
A combination of 2 or more technologies

Categories of studies established to evaluate abuse potential1

  • The FDA guidance describes 4 separate categories of studies for evaluating potential ADFs
  • Categories 1 and 2 are most relevant to unintentional misuse

Category 1

Laboratory manipulation and extraction studies (in vitro)

Category 2

Pharmacokinetic (PK) studies (in vivo)

Category 3

Clinical abuse potential/human abuse potential

Category 4

Postmarketing studies

As you know, opioids are not appropriate for all patients. But for those who are ideal candidates, education and practice of safe and proper use is essential for treatment success.

References:

1. US Food and Drug Administration. Center for Drug Evaluation and Research (CDER). www.fda.gov/downloads/Drugs/Guidance-ComplianceRegulatoryInformation/Guidances/UCM377938.pdf. Accessed March 15, 2016.

2. Moorman-Li R, Motycka CA, Inge LD, Congdon JM, Hobson S, Pokropski B. A review of abuse deterrent opioids for chronic nonmalignant pain. P&T. 2012;37(7):412-418.

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To find out the correct answer, click on a question below

What proportion of patients misuse their opioid medication in the United States?

1 in 4

In a systematic review and data synthesis to clarify and calculate prevalence estimates, misuse was documented in approximately 1 in 4 patients (mean range: 21.7% to 29.3%). Misuse is defined as opioid use contrary to directed or prescribed use, regardless of the presence or absence of harm or adverse effects.1

True or false? The FDA recommends considering an ADF that addresses the patient’s individual needs.

True

The FDA recommends considering an ADF that suits the patient’s individual needs.2

In what year did the first opioids with abuse-deterrent properties receive FDA approval?

2010

Since 2010, several opioids with abuse-deterrent properties have been approved by the FDA, and more are in development.3

How many study categories have been established to evaluate abuse potential in new opioids?

4

The FDA guidance describes 4 separate categories of studies for evaluating potential abuse-deterrent opioid formulations. Category 1 refers to laboratory-based in vitro manipulation and extraction studies; Category 2 refers to pharmacokinetic studies; Category 3 refers to clinical abuse potential/human abuse potential studies, and Category 4 refers to postmarketing studies.2

True or false? Every patient who misuses opioid medication is doing so intentionally.

False

Not every patient who misuses opioid medication is doing so intentionally. Sixty-five percent of patients are unaware that crushing, cutting, or grinding can alter the way an opioid medication works. For example, a patient who dislikes swallowing pills may crush his or her medication to help make it easier to swallow, not realizing the consequences.4

Which studies are considered Category 2 for evaluating abuse potential?

PK studies in vivo

Pharmacokinetic studies conducted in vivo are considered Category 2.2
References:

1. Vowles KE, McEntee ML, Julnes PS, Frohe T, Ney JP, van der Goes DN. Rates of opioid misuse, abuse, and addiction in chronic pain: a systematic review and data synthesis. Pain. 2015;156(4):569-576.

2. US Food and Drug Administration. Center for Drug Evaluation and Research (CDER). www.fda.gov/downloads/Drugs/Guidance-ComplianceRegulatoryInformation/Guidances/UCM377938.pdf. Accessed March 15, 2016.

3. Moorman-Li R, Motycka CA, Inge LD, Congdon JM, Hobson S, Pokropski B. A review of abuse deterrent opioids for chronic nonmalignant pain. P&T. 2012;37(7):412-418.

4. Pergolizzi JV Jr, Taylor R Jr, Nalamachu S, et al. Challenges of treating patients with chronic pain with dysphagia (CPD): physician and patient perspectives. Curr Med Res Opin. 2014;30(2):191-202.