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Biotech / Medical : ARADIGM CORP. ARDM -- Ignore unavailable to you. Want to Upgrade?


To: tuck who wrote (134)3/18/2002 9:32:38 AM
From: tuck  Respond to of 255
 
>>HAYWARD, Calif., March 18 /PRNewswire-FirstCall/ -- Aradigm Corporation (Nasdaq: ARDM - news) today released detailed results from two Phase 2b trials that assessed the safety and efficacy of its morphine AERx® Pain Management System (AERx PMS). The system delivers aerosolized morphine via the AERx pulmonary drug delivery technology for the management of acute and breakthrough pain. More than 100 patients were treated in two separate studies completed in late 2001. The data demonstrated significantly faster onset of pain control and comparable overall pain relief when compared to immediate release oral morphine solution in one study and comparable pain relief when compared to intravenous morphine in the second study. ``Our patients were quite pleased with the rapid onset of pain relief they obtained from the AERx PMS,'' said Neal Slatkin M.D., a pain control expert at the City of Hope Medical Center, Duarte, California, who was an investigator on the AERx morphine cancer pain study. Dr. Slatkin continued, ``The electronic safety features Aradigm has built into its device will help to minimize the risk of overuse or abuse of the product.''

The results were reported in three poster presentations at the American Pain Society 21st Annual Scientific Meeting held last week in Baltimore. The American Pain Society is a multidisciplinary organization of basic and clinical scientists, practicing clinicians, policy analysts, and others.

In one poster presentation, John Thipphawong, M.D., Aradigm Medical Director, reported data from a study designed to compare the analgesic efficacy and safety of inhaled morphine with oral morphine for breakthrough cancer pain. In this study, in 16 patients with advanced cancer pain, statistically significant greater pain relief was achieved during the first 15 minutes after treatment when patients received AERx morphine compared to when they received immediate release oral morphine (AERx was ranked by patients at 28.6 vs oral morphine ranked by patients at 14.8; p=0.003). In addition, patients reported faster onset of pain relief on AERx morphine compared to immediate release oral morphine (AERx 6.6 minutes vs oral morphine 11.8 minutes; p=0.009). Significantly greater (AERx was ranked by patients at 397 vs oral morphine ranked by patients at 330; p=0.01) pain relief was achieved during the first 60 minutes after treatment with AERx morphine. Overall, inhaled morphine delivered with the AERx PMS system produced greater and more rapid analgesia than immediate release oral morphine solution.

Presenting the results from the other study which was designed to demonstrate the analgesic efficacy, dose-response and safety of AERx morphine in 89 patients following post-operative surgery, Dr. Thipphawong reported data that showed that three inhalations of inhaled morphine produced comparable onset of pain relief and extent of analgesia as 4 mg of intravenous (IV) morphine (2.4 minutes on AERx morphine versus 2.5 minutes for IV morphine).

``We are encouraged by these results, as they demonstrate the utility of inhaled morphine for the treatment of acute and breakthrough pain. We believe that the data reported in these studies support advancing our AERx morphine product into its final phase of development,'' said Richard Thompson, president and CEO of Aradigm. ``Rapid pain relief, patient safety and minimization of abuse potential will provide clear competitive advantages for this product.''

The abstracts are available for viewing on the American Pain Society web site at ampainsoc.org .

Abstract #771:

``Analgesic Efficacy of Inhaled Morphine Delivered with the AERx® mPMS for Breakthrough Cancer Pain''

Abstract #798:

``Single Dose Analgesic Efficacy of Inhaled Morphine Delivered with the AERx® morphine Pain Management System (mPMS) after Orthopedic Surgery''

Abstract #799:

``Multidose Efficacy of Inhaled Morphine Delivered with the AERx® Pain Management System for Outpatient Orthopedic Surgery''<<

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Cheers, Tuck