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

To: rkrw who wrote (133)	12/19/2001 9:55:25 AM
From: tuck	Read Replies (1) \| Respond to of 255

>>HAYWARD, Calif., Dec. 19 /PRNewswire/ -- Aradigm Corporation (Nasdaq: ARDM - news) today announced that it has successfully completed Phase 2b clinical trials for its morphine AERx (R) Pain Management System (AERx PMS). The system delivers morphine via the AERx pulmonary drug delivery technology for the management of acute and breakthrough pain. Over 100 patients were treated in two separate studies recently completed. ``The completion of this phase of development of our AERx PMS represents a significant milestone for our company. We are particularly pleased that the efficacy of our product is comparable to intravenous morphine. We were also pleased that AERx PMS provides significantly faster pain relief than immediate release oral morphine commonly used for the management of breakthrough pain,'' said Rick Thompson, president and CEO of Aradigm. ``With these safety and efficacy data, we have achieved our goals for this stage of development.'' In a study of 16 patients with breakthrough pain from advanced cancer, AERx morphine demonstrated significantly faster onset of pain control and comparable overall pain relief when compared to immediate release oral morphine solution. More patients selected AERx morphine as the treatment of choice for further management of their breakthrough pain compared to the oral morphine solution. In a separate study of 89 patients with acute postoperative pain, the AERx PMS was shown to provide pain relief comparable to intravenous morphine when given in similar doses. The study also demonstrated that similar doses of AERx morphine and intravenous morphine were superior to placebo on pain control, using standard pain intensity and pain relief endpoints. Adverse events for the AERx morphine were comparable to those seen in patients dosed with IV morphine. The postoperative population is a widely accepted model for studying the effectiveness of medications for acute pain. ``The morphine delivery system being developed by Aradigm represents a significant breakthrough in pain management. With its rapid onset of pain relief, it provides unique in-home management of pain in cancer patients,'' says Richard Rauck M.D., an anesthesiologist and pain control expert at Wake Forest University, Winston Salem, NC, who also was an investigator on the AERx morphine cancer pain study. The detailed study results will be presented at scientific conferences during 2002. Following completion of this stage of development, Aradigm will be working with its partner GlaxoSmithKline, to determine the next steps for the AERx morphine program. Future development plans for the product, including the timing of Phase 3 clinical trials will be announced at a later date.<< snip Cheers, Tuck

To: rkrw who wrote (133)	5/10/2002 12:52:31 AM
From: tuck	Read Replies (1) \| Respond to of 255

rkrw, If nothing else, Aradigm seems to have one heckuva an inhaler: >> Chest 2002 Mar;121(3):871-6 Related Articles, Books, LinkOut Accuracy of three electronic monitors for metered-dose inhalers. Julius SM, Sherman JM, Hendeles L. Pediatric Pulmonary Division, University of Florida, Gainesville, FL 30342, USA. StevenJulius@aol.com BACKGROUND: Prior studies indicate that some devices used to monitor metered-dose inhaler (MDI) use are not accurate. OBJECTIVE: To assess the accuracy of the Doser CT (NEW-MED Corporation; Waltham, MA), the MDILog (Medtrac Technologies; Lakewood, CO), and the SmartMist (Aradigm Corporation; Hayward, CA) in a bench-top study. DESIGN: One, two, and four puffs of fluticasone propionate MDI (Flovent; GlaxoWellcome; Research Triangle Park, NC) were actuated twice daily for 30 days with two units of each device. The date and time of each actuation were recorded in a log and then compared with the output of the device. The percentage of doses recorded accurately was compared by analysis of variance. Measurements and results: The SmartMist was 100% accurate, while both the Doser CT and MDILog devices occasionally recorded spurious actuations. The Doser CT also had missed actuations after the counter had prematurely reached zero secondary to the spurious recordings. The accuracy (mean plus minus SD) was 94.3 plus minus 2.9% for the Doser CT and 90.1 plus minus 6.9% for the MDILog (p = 0.21). The dose regimen actuated and duration of use did not significantly affect accuracy. CONCLUSION: All three devices are sufficiently accurate to monitor adherence in most clinical settings.<< Has ARDM given an indication of how much more their inhaler costs? I gather including a microprocessor adds some cost, and while it may not be worth it for Flovent, maybe it is for other things? Smarter people than I have wondered about applications for delivering small molecules. Now that the fibrosis issues have arisen from inhaling proteins, I can see why. Can you think of any such molecules that would benefit from precision pulmonary delivery (outside of the pain program)? Should they be talking to SEPR? TIA, and Cheers, Tuck