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An Overview of Abuse-Deterrent
Formulations (ADFs)
Kyle Simon, Director of Policy and Advocacy
March 29, 2015
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.
Rx Abuse Epidemic
•  CDC: prescription drug abuse is an epidemic
–  22,767 drug-related overdose deaths in 2013
•  71.3%involved opioids
•  30.6% involved benzodiazepines
–  2.4 million Americans used prescription drugs
nonmedically for first time in past year
•  1.9 million (80%) abused prescription opioids
–  98.4% increase in ED visits since 2004
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.
Abuse-Deterrent Formulations
•  Reduce likelihood of misuse and abuse (and
corresponding diversion) and related adverse
outcomes
–  Drug-liking qualities, attractiveness
–  Hinders extraction of active ingredients
–  Limits bioavailability
–  Prevents administration thru alternate routes
–  Less rewarding to manipulate product
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.
Impact of ADFs
•  Incremental reduction in abuse can have
significant impact on public health and safety
–  Costly social, physical, mental, and public health
problems result from abuse (e.g. teen pregnancy,
domestic violence, spread of infectious diseases,
motor vehicle crashes, homicide, suicide)
•  Do not completely deter abuse involving multiple
drug doses by oral administration
•  Beneficial to first-time, inexperienced, nondependent user of substances
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.
ADF Technologies
•  Physical barriers (e.g., harder to crush)
•  Chemical barriers (e.g., resists extraction of chemical
ingredient)
•  Antagonist/agonist (e.g., activates when product is
manipulated and defeats euphoria)
•  Aversion (e.g., unpleasant effect)
•  Delivery systems (e.g., implant)
•  Prodrugs (e.g., activated in GI tract)
•  Combination
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.
Status of ADF Adoption in the Market
•  To obtain ADF labeling by FDA, product must
reduce abuse compared to previously approved
version
–  Presumed that certain novel delivery systems (e.g.,
implants, injectables) are inherently abuse-deterrent
–  Pre-marketing and post-marketing studies
•  March 2015: 4 FDA-labeled ADFs
–  3 with physical/chemical barriers
–  1 with agonist/antagonist properties
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.
Federal Legislation
•  Bill to amend FD&C Act to spur development
of Schedule II ADFs
•  Calls for transition of already approved nonADF C-II products within 3 years
•  5-year data exclusivity for new ADFs
–  Access and cost concerns?
•  Requires FDA to publish final guidance
•  Coalition bill awaiting introduction
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.
Federal Legislation: H.R. 1353
•  Promoting Access for Treatments Ideal in
Enhancing New Therapies (PATIENT) Act
–  Sponsored by Rep. Gus Bilirakis (R-FL-12)
•  Incentivizes development of ADFs
–  Appears to advance an incomplete approach
–  Data exclusivity provision
•  Affordability and continuity of access are key
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.
State Legislation
•  2015: ADF legislation introduced in 23 states
•  Substitution/non-substitution
–  Preferred drug
–  Dispenser/insurer cannot override prescriber intent by
substituting non-ADF without prescriber authorization
•  Coverage
–  Government mandates on insurance companies
–  Cannot exceed non-ADF cost-sharing
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.
Future of ADFs
•  Lack of regulatory guidance holds back
investment, research, and development
•  FDA acknowledges science of ADFs in early
stages but “rapidly evolving”
•  FDA released draft guidance for branded
products in January 2013
•  Final guidance for branded products
expected by June 2015
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.
CLAAD ADF Manuscript
•  Full detail of ADF issue
with recommendations
for policy makers
•  claad.org/adfmanuscript
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.
Thank You
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American Association of Nurse Practitioners
Cindy Cooke, AANP
Angela Golden, AANP
Dr. Bob Twillman and American Academy of
Pain Management
•  Contact us:
–  ksimon@claad.org
–  www.linkedin.com/in/kyleasimon
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.