No more needles
For those who hate needles, Crossject’s new
product Zeneo will be a welcome relief. It
is a needle-free, pre-filled, single-use injection
device. Bruno Besse, MD Director Medical
Affairs scratches the surface.
French company Crossject is a leader in the design
and
development of innovative needle-free device technology
for the
pharmaceuticals industry. Its main product platform
Zeneo is a
needle-free injection device that is able to adapt
to different
injection depths (intradermal, subcutaneous, intramuscular)
and
the physical characteristics of the injectable
active substance. The
advantages offered by Crossject’s technology
include ease of use,
enabling products to be self-administered, elimination
of the risk of
needle-stick injury, improved accuracy both of
location and of dose
administered, and the elimination of needle phobia.
In partnership with the University of Bourgogne,
the company
has developed an innovative MRI method to assess
the clinical
performance of the device in human volunteers.
Overall, seven
clinical trials which included 198 volunteers
(281 injections) were
conducted with all versions of Zeneo. These were
randomised
controlled studies conducted in comparison with
conventional
needle injections.
Imaging was performed on a 3.0 T Siemens Trio
Tim magnet.
The protocol was carried out using a flexible
body coil strapped to
the injection site. The principle aim was to provide
images with a
sufficiently high contrast between the injected
liquid (saline
solution) and the surrounding tissues, and also
a high spatial
resolution to allow a precise localisation of
the injected medium in
the tissue as well as depth and volume injected.
The quality of the injection was also clinically
assessed (using
visual scales), along with its safety and tolerance.
Subcutaneous studies
Three studies (64 volunteers) were conducted,
for the assessment
of different volumes of injection (0.5 ml and
0.8 ml) and different
sites of injection (arm, thigh, abdomen). Each
subject received one
subcutaneous injection with Zeneo and one with
a syringe/
needle. The sequence of injection was randomised.
In all regards the product achieved results comparable
to those
of the standard needle syringe. All injections
in both groups were
well tolerated by all the subjects. No procedure-related
adverse
event was observed.
In one of the studies, the volunteers were also
asked to rate the
device versus the standard syringe/needle. Overall,
the preferences
were comparable, except that for
chronic treatment by self-injection,
87.5% said they would prefer the
device, compared to only 13% for the
needle; 67% had a very favourable or
favourable opinion of the device.
In conclusion, the Crossject
needle-free injection device is safe
and reliable for subcutaneous
injections. Its performance and safety
are comparable to the conventional
needle/syringe injection.
Intramuscular studies
Because the ex-vivo model in the laboratory was
less accurate for
intramuscular injections, the first magnetic resonance
imaging
(MRI) studies (90 volunteers) were used to fine-tune
results.
The objective of the last study conducted in
40 volunteers
with the final version was to compare the characteristics
by
magnetic MRI of an intramuscular injection in
the deltoid
using the Zeneo devices. The Crossject devices
performed
comparably with the standard injection, but with
greater
uniformity. The volume detected in the muscle
was at least as
good as measured with the needle, 0.46 ±
0.06ml for the
Crossject device versus 0.40 ± 0.09ml for
the needle and
syringe. There were no safety concerns in either
group.
Intradermal study
The results of the pilot intradermal study were
very
encouraging. A development plan for Zeneo intradermal
injection of vaccine is ongoing in partnership
with the
prestigious Pasteur Institute.
Next steps
These MRI studies are a confirmation of the safety
and
reliability of the Crossject Zeneo device. We
have now
evidence collected from several well-controlled
studies, for
subcutaneous, intradermal and intramuscular delivery
with
this product; it continues to prove its adaptability
to deliver
many types of injected products.
The next steps are to test the device using active
drugs.
This has already been done successfully with the
flu vaccine
in humans, the canine DNA vaccine and with therapeutic
proteins in pigs.
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