Pain Management System
HAYWARD, Calif., Dec. 19 /PRNewswire/ --
Aradigm Corporation (Nasdaq: ARDM) 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
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
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.
Aradigm is working to improve the quality of life of patients by
developing aerosol-based drug delivery alternatives to injectable
therapeutics. The Company's advanced pulmonary delivery technologies provide
leading pharmaceutical and biotechnology partners with effective drug delivery
solutions. Aradigm's technology uses liquid drug formulations that are
similar to the injectable forms and minimize the potential for safety concerns
when delivered by the pulmonary route. Current development programs focus on
diabetes, pain management, and the pulmonary delivery of existing and emerging
Based in Hayward, California, Aradigm is currently developing products for
diabetes management with Novo Nordisk A/S, the world leader in insulin and
diabetes care, and breakthrough and acute pain management for GlaxoSmithKline,
a world leader in oncology therapy and supportive care. In addition, Aradigm
has three additional partner-funded programs and a gene therapy effort funded
through the National Institutes of Health. More information about Aradigm can
be found at www.aradigm.com. Investors may also request company information
via email by directing inquiries to email@example.com.
Except for the historical information contained herein, this news release
contains forward-looking statements that involve risk and uncertainties,
including 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 its Quarterly Reports on Form 10-Q.
AT ARADIGM CORPORATION:
Investor Relations Coordinator
Feinstein Kean Healthcare
Ogilvy Public Relations Worldwide
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SOURCE Aradigm Corporation
/CONTACT: Tracy Hudson, Investor Relations Coordinator of Aradigm,
+1-510-265-9000; or INVESTORS: Kari Lampka of Feinstein Kean Healthcare,
+1-617-577-8110; or MEDIA: Claire Campbell of Ogilvy Public Relations
/Web site: http://www.aradigm.com/
CO: Aradigm Corporation
IN: BIO MTC
-0- Dec/19/2001 11:15 GMT
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