Supplemental Content: Living Well with Migraine Disease and Headaches

Keep up with Migraine & headache news, tips, tools, and more... View our blog!


 

Needle-Free Triptan Injections?
They May Be On the Way!

November 17, 2004

  

Those who use sumatriptan, aka Imitrex and Imigran, may be familiar with the StatDose delivery system shown here. It's an auto-injector system that utilizes a short, subcutaneous needle. Injectable medications, including sumatriptan, generally work far more quickly than other forms of the same medications. 

Last week, Aradigm Corporation announced positive results from a pilot program using their needle-free Intraject® system to deliver subcutaneous sumatriptan injections. They issued the following press release:

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."

Aradigm develops non-invasive delivery systems to enable patients to comfortably self-administer biopharmaceuticals and small molecules that would otherwise be given by injection. The company's advanced AERx(R) pulmonary and Intraject(R) needle-free delivery technologies offer rapid delivery solutions for liquid drug formulations. Current development programs focus on neurological disorders, heart disease, respiratory conditions and cancer. More information about Aradigm can be found at http://www.aradigm.com.

Except for the historical information contained herein, this news release contains forward-looking statements that involve risk and uncertainties, including clinical results, the timely availability and acceptance of new products, the impact of competitive products and pricing, and the management of growth, as well as the other risks detailed from time to time in Aradigm Corporation's Securities and Exchange Commission (SEC) Filings, including the company's Annual Report on Form 10-K, and quarterly reports on Form 10-Q.

 

   
NOTE: The information on this site is for education and support only. It is not medical advice and should not be construed as such. Always consult your physician if you have new or different symptoms. Never change your treatment regimen or add herbals, supplements, etc., without consulting your doctor.

 The American Headache and Migraine Association (AHMA)...

a patient-focused, patient-driven organization for patients with Migraine and
other headache disorders and their family, friends, and care partners.
Anyone interested in the concerns or patients with these disorders is welcome to join.

The AHMA exists to EASE the burden of Migraine and other headache disorders through Education, Awareness, Support, and Engagement.

www.ahma.ws


 

This website is certified by Health On the Net Foundation. Click to verify.This site complies with the HONcode standard for trustworthy health information: verify here.
    

Search only trustworthy HONcode health websites:

NOTE: The information on this site is for education and support only. It is not medical advice and should not be construed as such. Always consult your physician if you have new or different symptoms. Never change your treatment regimen or add herbals, supplements, etc., without consulting your doctor.

All content on this site is physician reviewed by Dr. John Claude Krusz.

Our Mission & Purpose  •   About the Information on This Site  •   Our Privacy Policy  •   Site Funding, Advertising, & Linking  •   Contact

All content © 2004 - 2014, Teri Robert unless otherwise indicated. • All rights reserved.
Last updated Saturday, September 27, 2014.

Page copy protected against web site content infringement by Copyscape

 
     
 
advertisement  

Looking for awareness items? Your search is over...

"Headaches Do Not Have Me" Mug

from Cafe Press

"Not the Boss" Thermos Tea Tumbler

from Cafe Press

"Knowledge Is Power"
Tile Box

from Cafe Press

"Migraines Are Not the Boss of Me!"

from Cafe Press

 

You can find these and other items in our Awareness Shop!

advertisement

advertisement

Google
  Web www.helpforheadaches.com