>>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.<<
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Cheers, Tuck |
