Assessing Abuse Deterrence for New and Low Market Share Products: The absence of evidence is not the evidence of absence

In March, Inflexxion’s Founder and Chief Strategy Officer, Simon Budman, presented at the Abuse Deterrent Formulation Summit.  The presentation, titled “Assessing Abuse Deterrence for New and Low Market Share Products:  The absence of evidence is not the evidence of absence,” gave an in-depth look at a number of innovative approaches and novel data streams used in measuring abuse deterrence even for new and low market share products.

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Overview: Inflexxion’s Founder and Chief Strategy Officer, Simon Budman, recently presented at the Abuse Deterrent Formulation Summit.  The presentation, titled “Assessing Abuse Deterrence for New and Low Market Share Products:  The absence of evidence is not the evidence of absence,” gave an in-depth look at a number of innovative approaches and novel data streams used in measuring abuse deterrence even for new and low market share products.

Few possible abuse deterrent opioid formulations have achieved large market as measured by number of prescriptions.  This makes it very difficult to measure a product’s abuse deterrent features.  A low market share product in the “real world” may show low abuse or misuse for many reasons:

1. It may truly be abuse deterrent and not attractive to abusers and misusers
2. It may be unavailable, hard to find or so expensive that abusers can’t really “test” that product and attempt to use it
3. Non-abuse deterrent alternatives may be so plentiful that there is little need for the abuser to even consider expending time, effort and money obtaining a new ADF product.

All of these factors make studying a newly introduced or low market share ADF product difficult.

In his presentation, Dr. Budman discussed a number of innovative approaches and novel data streams to use in measuring abuse deterrence even for new and low market share products.  When combined, these approaches allow the use of what is called a Weight of the Evidence (WoE) approach.  In using such an approach, data from a variety of sources is combined systematically and directionality of information is assessed.

The approaches described by Dr. Budman give a better understanding of the data needs for a product prior to NDA submission and is also helpful in measuring the likely ADF characteristics post-launch.