Researchers, led by scientists at Aradigm Corporation, (Nasdaq: ARDM - News) have published results of a clinical study involving the AERx Pain Management System in the September, 2003 issue of the journal Anesthesiology. Results from the clinical study demonstrated that inhalation of morphine via the AERx System was safe, well-tolerated while producing comparable pain relief as intravenous morphine. Anesthesiology is a peer-reviewed journal of the American Society of Anesthesiologists.
The study examined the administration of multiple doses of inhaled morphine, intravenous morphine or placebo to 89 patients following orthopedic bunionectomy surgery. Patients received multiple doses of either inhaled morphine via the AERx System, 4mg of morphine given intravenously or placebo. Observed for an 8-hour period immediately following their surgery, each patient's pain was measured by a change in pain intensity and pain relief and the peak pain intensity difference and relief. Results showed similar efficacy in onset of pain relief between the inhaled and intravenous delivery methods and superior efficacy to placebo.
"This study demonstrates the potential benefits of administering opioids via the lung and the lung's ability to deliver drugs into the bloodstream," said Najib Babul, CEO of Theraquest Biosciences and co-author of the study. "It also shows that the AERx platform may provide a viable new method of outpatient analgesic care and an attractive alternative to the traditional patient controlled analgesic systems used in hospital postoperative care settings."
Dr. Babul has been engaged in analgesic drug development for over 15 years. He has published extensively in the areas of acute pain and chronic pain, with over 90 scientific communications to his credit. He serves as a scientific reviewer for a number of peer-review journals in the areas of analgesia and clinical pharmacology. He is currently CEO and Chief Scientific Officer of Theraquest Biosciences a health-sciences consulting company providing drug development services in the fields of analgesia and rheumatology.
The results from this study were formally presented at two scientific meetings in 2002.
About the AERx Pain Management System
The AERx Pain Management System is designed to rapidly and non-invasively alleviate acute or breakthrough pain by delivering morphine, fentanyl or other opioids rapidly into the bloodstream via the lungs. Based on the proprietary AERx technology, this system has a patented "lock out" mechanism that offers physicians the opportunity to tailor dosing regimens on a patient-by-patient basis and is designed to prevent misuse or abuse of the system. In clinical trials, this AERx system has been shown to be analogous to hospital-based patient controlled analgesia systems except without the need for IV solutions or pumps.
Aradigm is working to improve the quality of life for patients through the development of its innovative needle-free drug delivery platforms. The Company's AERx® advanced pulmonary delivery platform and its Intraject® needle-free injector system provide leading pharmaceutical and biotechnology partners with effective drug delivery solutions. Aradigm's technologies both use liquid drug formulations to deliver drugs to the targeted area of either the lung, or the systemic circulation. The company is in Phase 3 clinical trials for the treatment of diabetes in a partnership with Novo Nordisk, a world leader in diabetes care. 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 as amended, and quarterly reports on Form 10-Q.
NOTE: AERx, and Intraject are registered trademarks of Aradigm Corporation.
CONTACT: media, Chris Keenan of Aradigm, +1-510-265-9370; or investors, Joe Dorame of RCG Capital Markets Group, Inc., +1-480-675-0400.
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