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Anesiva Announces FDA Approval of Supplemental New Drug Application to Expand Zingo(TM) Indication
Date:1/9/2009

SOUTH SAN FRANCISCO, Jan. 9 /PRNewswire-FirstCall/ -- Anesiva, Inc. (Nasdaq: ANSV) today announced that the U.S. Food and Drug Administration (FDA) has approved Anesiva's supplemental New Drug Application (sNDA) to expand the indication for Zingo(TM) to treat the pain associated with blood draws to include adults. Zingo (lidocaine hydrochloride monohydrate) powder intradermal injection system was previously approved to treat the pain associated with peripheral IV insertions and blood draws in children three to 18 years of age. The notification was received according to PDUFA deadlines.

As announced in November 2008, Anesiva ceased Zingo commercial activities to focus on the development of Adlea(TM), its novel non-opioid, long-acting analgesic drug candidate for the management of acute pain following orthopedic surgeries. Anesiva is seeking to license Zingo as well as the underlying drug delivery technology and intellectual property.

About Anesiva

Anesiva, Inc. seeks to be a leader in the development and commercialization of novel pharmaceutical products for pain management. Anesiva's lead product candidate is Adlea, a novel small molecule formulation of capsaicin that is currently in development for the management of acute pain following orthopedic surgeries. Adlea has been shown in clinical trials to provide extended pain relief after only a single administration in multiple indications for site-specific, acute and chronic, moderate-to-severe pain.

In December 2008, Anesiva announced that a Phase 3 trial of Adlea achieved its primary efficacy endpoint of reduced post-surgical pain versus placebo (p=0.03) following total knee arthroplasty (TKA, or total knee replacement surgery) at four to 48 hours after surgery. The trial also met its key secondary endpoint with Adlea demonstrating
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SOURCE Anesiva, Inc.
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Related medicine technology :

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