There are 33,000 people that are dying
every year from overdoses. There is an
urgency to come up with a solution.
We are interested in the opioid issue in
general from two perspectives as it
relates to addiction. On the one hand, can
we develop other medications that can be
used to treat people that are addicted
to opioid use, opioids and so that
suffer from an opioid use disorder.
We're also interested in developing
formulations of currently available
medications used for the treatment of
opioid use disorders that would be
easier for a patient to be compliant
with or will allow us to treat
patients that are difficult to reach; for
example, individuals that may be in a
rural community where you don't have
access to a methadone clinic or a
clinician that can provide with
buprenorphine. So in that respect, for
example, extended-release formulations
can actually provide a very useful tool
to manage an opioid use disorder problem.
But we're also interested in expanding
access to medications that can be
effective in reversing opioid overdoses
that are a result of more potent
synthetic opioids, like what we are
observing with fentanyl, or, in
certain cases, even with carfentanil,
for which evidently the naloxone doses
that are used to actually revert an
overdose from heroin may not
necessarily be sufficient. And very
importantly, we're interested in
developing therapeutic interventions
that can prevent an overdose, because
what we're observing is that an
individual that has overdosed from an
opioid has a much higher risk of
overdosing again, and if you don't do an
intervention these individuals will
overdose and some of them unfortunately
will die, so what is it that we
can do to protect them? And the third
aspect on our approach to address the
opioid use disorders with science is to
develop alternative treatments for the
management of chronic pain that are
effective and are not addictive. And this
is very important because the opioid
crisis emerged
from a very good intention to
properly treat patients suffering from
severe pain. But we didn't have many
alternative medications, and as a result
of that there became an over-reliance
or no appeal in the
prescription of opioid medications at
such a level that it actually so many
prescriptions were given that it became
easy to divert them and then these were
abused, and then, on the other side, it
also happened that patients were with
pain that were properly treated became
also addicted to the opioid medications.
And these two different routes generated
and open up the doors for the opioid
crisis that we currently have. So, how do
if we want to contain the epidemic,
because the patients with chronic pain
are in need of treatment, and we want to
prevent it from happening in the future
we need to solve the problem and need of
those with severe or moderate chronic
pain conditions for which as I say they
are very limited alternative treatment
interventions. We are very interested in
the concept of vaccine and monoclonal
antibodies in terms of can we generate
the vaccine that through which you
actually the person will generate
antibodies that will then bind the drug
in the blood, capturing it and
interfering it from it to go into the
brain and therefore you will not be able
to get high, and you also will interfere
with overdoses because the drug will not
get into the brain. And these vaccines
have been tested in pre-clinical models
and they have been shown to be effective
in fact in curtailing the entry of
morphine and heroin and actually
fentanyl into the brain, so we are at the
stage now to bring to get that
toxicology data to accelerate what is it
that we can accelerate, what do we need
to do to bring them and start to test
them in the clinic. And in that respect,
for example, we are particularly
interested in expanding development of
long-lasting monoclonal antibodies which
could actually, for example, provide
protection against overdosing from
highly potent synthetic opioids, such as
is the case of fentanyl where it's
actually other interventions have not
shown to be very beneficial. So that
is where we are at. It's more on the
preclinical stage, but we do have clear
cut plans and we partner with
pharmaceuticals and with academic
centers to accelerate the development to
different strategies. Actually, we're
working with two different vaccines for
heroin and we're working and trying to
facilitate the development into long-
lasting monoclonal antibodies for
fentanyl. I would say that is fundamental
to recognize that when we have a crisis
like this one, science first of all can
come up with the solutions to solve it,
but it's also in order to translate that
science into product the need to
generate public-private partnerships
becomes fundamental, and this is what
we are trying to do through this
commentary, to actually facilitate what
is it that we can do to facilitate that
transition? So we fund basic science and
knowledge that is indispensable
ultimately in generating treatments, but
that road can take a very long time.
So the concept is what is it that we can
do to accelerate it so it's not so long,
because we really don't have the time
and there are 33,000 people
that are dying every year from overdoses.
There is an urgency to come up with a
solution, and so how do we maximize that
likelihood?