Pharmaceutical Commerce - September/October 2017 - 19

Market Access
shift opioid formulations to abuse-deterrent
ones-but this has been happening without
a law being passed.
FDA has allowed for "abuse deterrence"
to be part of reformulated drugs' label; there
are currently nine so described, and another
nine in late-stage FDA review. (One, Endo
Pharma's Opana, was to be withdrawn from
the market in June, due to a review panel's
recommendation that its risks outweighed
its benefits.)
A study published in August by the
Institute for Clinical and Economic Review
(ICER) paints a discouraging picture of the
impact of ADFs on addiction. Clinical data
on ADF abuse prevention is sketchy-the
testing of such drugs involves trials with
nonaddicted recreational drug users; and an
ADF that works in the lab can be found to
be subverted in the real world by techniques
that quickly get shared among drug abusers.
(One profoundly simple abuse is to take
more of them at the same time.) ADFs are
significantly more expensive than their nonreformulated, generic equivalents. ICER,
which has established a reputation for
rigorous comparative-effectiveness analysis,
concluded that for every 100,000 chronic
pain patients who are switched from
traditional painkillers to an abuse-deterrent
version, healthcare system costs would rise
by $500 million over five years. Preventing
even just one overdose death represents
more than $1 billion in healthcare costs.
In press reports of the ICER study,
Dan Cohen, head of the Abuse Deterrent
Coalition, is quoted as saying "At its core,
the report basically asked the question: Can
these products do what they're not designed
to do? Not surprisingly the answer is no,"
noting that "They can't prevent addiction
because they're not designed to prevent
addiction."

specifically Data200, opened up pathways
for addiction therapy, and have insurance
companies provided coverage for MAT.
Dr. Sullivan is the co-founder of
Bridge Therapeutics (Birmingham, AL),
which is pursuing FDA approval of drug
combination BT-205 for the treatment
of chronic pain in opioid-experienced
patients. The drug contains an NSAID,
meloxicam, plus buprenorphine, a partial

opioid agonist that has superior painrelieving properties, is non-tolerance
developing and is considerably safer than
traditional opioids. BT-205 is targeted for
chronic pain sufferers who need a solution
to address their high levels of pain without
becoming helplessly addicted-and whose
only other prescription choices currently
are full agonist (traditional) opioids, he
says. Dr. Sullivan expects approval of the

investigational drug in 2019 under the FDA's
505(b)(2) approval process, which addresses
new formulations of existing drugs.
"Chronic pain affects more Americans
than diabetes, heart disease and cancer
combined, which means that-more than
ever-providers need access to effective,
safer and less addictive pharmaceutical
treatments to help their patients."

MAT to the rescue?
The market for therapeutic drugs for
opioid addiction, while maintaining a
pulse, is best characterized as "stunted."
Medication-assisted treatment (MAT) has
been around for years-the earliest version
was the methadone programs originally for
heroin addicts. Now, Suboxone and various
other products based on buprenorphine are
available; however, most addiction centers
still operate in the belief that abstinence is
the best course of action, despite data from
(among others) HHS that show beneficial
outcomes from MAT programs.
Greg Sullivan, MD, is a physician that
is board-certified in addiction medicine
and has been a clinical trial investigator for
the past 25 years, overseeing clinical trials,
including safety and efficacy studies for
every buprenorphine product currently
approved for the US market. Many patients
undergoing MAT, depending on the MAT
medication, need to be carefully monitored,
he says. Even though physicians can be
certified (via a one-day course) to prescribe
MAT using buprenorphine, relatively few
have done so until recently. Similarly, only
in recent years has federal regulation,
September | October 2017 Visit our website at www.PharmaceuticalCommerce.com 19


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Table of Contents for the Digital Edition of Pharmaceutical Commerce - September/October 2017

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Pharmaceutical Commerce - September/October 2017 - Cover2
Pharmaceutical Commerce - September/October 2017 - Table of Contents
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Pharmaceutical Commerce - September/October 2017 - Cover3
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