Many triptan users are already familiar with the Imitrex (sumatriptan) StatDose delivery system.
It's an auto-injector system that utilizes a short, subcutaneous needle. These
injections work more quickly than other forms of triptans, but many triptan
users shy away from them because they don't like needles.
Last week, Aradigm Corporation announced positive results from a pilot program
using their needle-free Intraject® system to deliver subcutaneous sumatriptan
injections. They issued a press release, part of which is reproduced below:
HAYWARD, Calif., Nov. 17 /PRNewswire-FirstCall/ -- Aradigm Corporation (Nasdaq:
ARDM) today announced positive results from a pilot pharmacokinetic study in
which sumatriptan delivered via its needle-free Intraject(R) system was compared
to the currently marketed subcutaneous needle-injected sumatriptan product.
Sumatriptan is indicated for the acute treatment of migraine headache. Results
from the study showed that sumatriptan administered via the Intraject system met
all bioequivalence criteria and demonstrated statistically equivalent
pharmacokinetics to the marketed injectable product.
"This study provides the final validation of Intraject as the system
successfully delivered active drug," said Dr. Bryan Lawlis, Aradigm's President
and Chief Executive Officer. "We have funded this program to date in order to
demonstrate conclusively that Intraject needle-free delivery is a viable
replacement for conventional subcutaneous injection, and to accelerate our path
to first product launch. In the first half of 2005, we anticipate manufacturing
registration lots and preparing for pivotal bioequivalence trials in the second
half of the year. We are encouraged that our rapid progress is generating
attractive partnering prospects for this product, as well as for other products
that are currently marketed or being developed for subcutaneous delivery."
The trial was a randomized, open-label, single-dose, crossover study evaluating
the pharmacokinetics of sumatriptan at three injection sites in 18 healthy adult
male and female volunteers. Subjects were randomized to receive sumatriptan both
by Intraject and by the currently marketed subcutaneous needle-injected
sumatriptan product into the abdomen, thigh, and arm.
The comparability of Intraject to the subcutaneous needle-injected sumatriptan
product was established at all three injection sites using standard
bioequivalence criteria of peak concentration achieved in blood plasma (Cmax),
and total drug concentration in blood plasma achieved over time (AUC). Other
pharmacokinetic measures were similar between Intraject and the needle-injected
product, and there was no significant difference in blood levels between the two
products.
"This positive data means that Intraject has the potential to be competitively positioned in the $2 billion triptan market," said Dr. Stephen
Farr, Senior Vice President and Chief Scientific Officer of Aradigm. "Rapid
absorption is important for achieving rapid relief in the treatment of migraine
attacks. To date, the performance of injected sumatriptan has not been equaled
by any oral triptan. We expect that patients seeking faster pain relief will be
pleased to have an effective option that does not involve a needle."
>>For an article with the full press release, click
HERE.<<
