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Anesiva Commences Phase 3 Clinical Trial of Adlea(TM) for Reducing Post-Surgical Pain Following Bunionectomy
Date:3/25/2008

SOUTH SAN FRANCISCO, Calif., March 25 /PRNewswire-FirstCall/ -- Anesiva, Inc. (Nasdaq: ANSV) today announced the initiation of a pivotal Phase 3 trial evaluating Adlea(TM), its long-acting, non-opioid analgesic drug candidate, in patients following bunionectomy surgery. The multicenter, double-blind, placebo-controlled trial will evaluate the efficacy and safety of Adlea in reducing post-surgical pain in patients undergoing a bunionectomy procedure. Adlea, which is designed to provide pain relief for weeks to months after a single local application, has already demonstrated statistically significant pain reduction in this clinical setting.

A bunionectomy is a surgical procedure that is performed to align the bones of the big toe joint by removing a bunion, which is an enlargement of the joint at the base of the big toe. An estimated 292,000 bunionectomy surgeries are performed in the U.S. each year.

"Because bunionectomies are often performed as out-patient procedures, patients are responsible for their own pain management following surgery. Adlea could fill an important need since it does not require repeated administrations after the initial application during surgery," said Dr. Eric L. Diamond, a podiatrist practicing in Maryland who is an investigator on the Phase 3 study and who also participated in a Phase 2 study of Adlea in bunionectomy surgery. "Furthermore, because Adlea is administered at the surgical site, its effects are targeted. In contrast to systemic pain medications such as opioids, Adlea appears to avoid potentially serious side effects on cognitive function and other organs or muscle groups. This profile affords it the potential to be safely used in conjunction with, and possibly reduce the need for, othe
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SOURCE Anesiva, Inc.
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