MedicalDevice Licensing.com
Pharmalicensing.com
Latest: Watch here for details of new products and services.
RSS Feeds
Advanced search

Login  Register

About Us
Pharmalicensing - Partnering solutions for the life sciences
 
Our Products
Overview
Partnering Search
Company Profiling
Deal Negotiation
PL Intelligence
Reports
Comparison
 
PL Intelligence
Overview
Industry news
Deals review
Press releases
Articles
 
Case Studies
See what others think about our service
 
Newsletter
Partnering update
Key reports
Subscribe
 
Quick Links
Profile now
Register now
Profiled companies
Featured events
Industry news
PR Newswire
Jobs
 
Contact Pharmalicensing
Send an email
Call us: +44 1904 520460
Request a callback
 
RSS Feeds
Keep up to date

Pharmalicensing
is a division of
UTEK Europe Ltd
UTEK Corporation
Press releases

Stay current with the latest press releases from within the industry.

Aradigm Advances Development of Intraject Sumatriptan With New Clinical Trial Data

Release issued 13th July 2005

HAYWARD, Calif., June 29 - Aradigm Corporation (Nasdaq: ARDM) today announced positive results from a self-injection study in which healthy naive users successfully administered sumatriptan via its needle-free Intraject(R) system, achieving bioequivalent blood plasma levels to the currently marketed subcutaneous needle-injected product. This clinical trial is part of an ongoing initiative at Aradigm to develop and launch the first needle-free injectable triptan for treatment of migraine and cluster headaches.

"This data confirms that subjects can self-administer using Intraject and gain a clinically relevant outcome," said Dr. Bryan Lawlis, Aradigm's President and Chief Executive Officer. "We believe that this data, combined with the outstanding clinical performance from previous trials, reinforces Intraject as a commercially-significant needle-free platform. In addition, we believe the simplicity of the system will be very important for migraine patients who are frequently cognitively-impaired during their migraine attacks and as a result find injections very difficult to do. This, together with the needle-free advantage, is likely to favorably position this product for the treatment of migraine headache."

The trial was a randomized, open-label, single-dose, crossover study evaluating the pharmacokinetics of sumatriptan at three injection sites in 24 healthy adult male and female volunteers naïve to self-injection with Intraject. Subjects were asked to dose themselves in the thigh, abdomen and arm. The comparability of Intraject to the subcutaneous needle-injected sumatriptan product was established for pooled data across the 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.

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 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: AERx and Intraject are registered trademarks of Aradigm.

Company details

If you want to find out more about the company visit Aradigm profile.

Latest Aradigm press releases

More Press Releases

Related categories

Therapeutic target
Central Nervous System
Neurological
Migraine
Industry sector
Biotechnology
Drug delivery
Parenteral
Needle-less

Clients in focus...

Get the Flash Player to see this rotator.

Partnering discussion free of charge
BioTrinity
Press releases: Pharmalicensing current industry press releases.

© Copyright 1995-2009 Pharmalicensing, a division of UTEK Europe Ltd UTEK Corporation All rights reserved. Terms and Conditions | Contact us