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Anesiva Announces Adlea ACTIVE-1 Phase 3 Clinical Results, Ceasing of Zingo Commercial Operations and Restructuring
Date:11/10/2008

Conference Call Scheduled for November 11, 2008 at 9:00 am ET

SOUTH SAN FRANCISCO, Calif., Nov. 10 /PRNewswire-FirstCall/ -- Anesiva, Inc. (Nasdaq: ANSV) today announced that the ACTIVE-1 Phase 3 trial evaluating Adlea(TM), a novel formulation of capsaicin, narrowly missed its primary endpoint of reducing post-surgical pain versus placebo (p=0.07) following bunionectomy surgery at four to 32 hours post-surgery. The same measure was highly significant (p=0.004) from four to 48 hours post-surgery. The trial also achieved a key secondary endpoint of reducing opioid use for Adlea versus placebo (p=0.012) over the four to 32 hour period. Adverse events were similar for both active treatment and placebo groups. Results of a second Phase 3 trial of Adlea, in total knee replacement surgery, will be announced next month.

"It is important to note that the four to 32 hour pain measure reflected the inpatient period where activity is most restricted," said William Houghton, M.D., Anesiva senior vice president and chief medical officer. "In contrast, non-weight bearing mobilization increased during the latter period. Thus, the longer duration four to 48 hour measure highlights important analgesic potential for Adlea. We expect this to be confirmed in the upcoming ACTIVE-2 total knee arthroplasty study which uses the same four to 48 hour analgesic measure as its primary endpoint."

Anesiva has determined that it will cease further commitments to support Zingo commercialization as a result of continued manufacturing challenges and the need to recall product in the field due to a potential non-safety related shelf life issue from a lot of unreleased product. Anesiva plans to seek a device-oriented partner for this asset. The compan
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SOURCE Anesiva, Inc.
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Related medicine technology :

1. Anesiva Accelerates Its Transition to Specialty Pharma Pain Management Company
2. Anesiva Commences Phase 2 Trial of Adlea(TM) in Arthroscopic Shoulder Surgery
3. Anesiva Announces South Korea FDA Approval of Adlea(TM) Investigational New Drug Application
4. Anesiva Announces Publication of Phase 3 Zingo(TM) Data in the Journal Pediatrics
5. Anesiva Announces Pivotal Phase 3 Clinical Trial of Adlea(TM) for Reducing Post-Surgical Pain Following Total Knee Replacement
6. Anesiva Commences Phase 3 Clinical Trial of Adlea(TM) for Reducing Post-Surgical Pain Following Bunionectomy
7. Anesiva Announces Pivotal Phase 3 Trial of Zingo(TM) Meets Primary Endpoint and Significantly Reduces Venous Access Pain in Adults
8. Anesiva Defines Regulatory Pathway for Adlea with FDA
9. Anesiva Initiates Phase 2 Trial with Adlea(TM) for Pain Relief Following Total Hip Replacement Surgery
10. Anesiva Initiates New Phase 2 Trial of Adlea(TM) for Pain Relief Following Knee Replacement Surgery
11. Anesiva Completes Enrollment in Phase 3 Clinical Trial of Zingo(TM) to Treat Pain Associated With Venous Access Procedures in Adults
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