SOUTH SAN FRANCISCO, Jan. 9 Anesiva, Inc.(Nasdaq: ANSV) today announced that the U.S. Food and Drug Administration(FDA) has approved Anesiva's supplemental New Drug Application (sNDA) toexpand the indication for Zingo(TM) to treat the pain associated with blooddraws to include adults. Zingo (lidocaine hydrochloride monohydrate) powderintradermal injection system was previously approved to treat the painassociated with peripheral IV insertions and blood draws in children three to18 years of age. The notification was received according to PDUFA deadlines.
As announced in November 2008, Anesiva ceased Zingo commercial activitiesto focus on the development of Adlea(TM), its novel non-opioid, long-actinganalgesic drug candidate for the management of acute pain following orthopedicsurgeries. Anesiva is seeking to license Zingo as well as the underlying drugdelivery technology and intellectual property.
Anesiva, Inc. seeks to be a leader in the development andcommercialization of novel pharmaceutical products for pain management.Anesiva's lead product candidate is Adlea, a novel small molecule formulationof capsaicin that is currently in development for the management of acute painfollowing orthopedic surgeries. Adlea has been shown in clinical trials toprovide extended pain relief after only a single administration in multipleindications for site-specific, acute and chronic, moderate-to-severe pain.
In December 2008, Anesiva announced that a Phase 3 trial of Adlea achievedits primary efficacy endpoint of reduced post-surgical pain versus placebo(p=0.03) following total knee arthroplasty (TKA, or total knee replacementsurgery) at four to 48 hours after surgery. The trial also met its keysecondary endpoint with Adlea demonstrating a highly significant reduction inopioid medication consumption compared to placebo (p=0.005).
The Phase 3 TKA trial, known as ACTIVE-2 (Assessment of highly purifiedCapsaicin To ImproVE pain management after orthopedic surgery), also showedthat Adlea's safety profile of adverse events, wound healing, and woundsensory function were similar to placebo over the study duration.
Anesiva is based in South San Francisco, CA. For more information, go towww.anesiva.com.
This press release includes "forward-looking statements" within themeaning of the safe harbor provisions of the United States Private SecuritiesLitigation Reform Act of 1995. Words such as "seek" and similar expressionsare intended to identify such forward-looking statements. Forward-lookingstatements in this press release include matters that involve known andunknown risks, uncertainties and other factors that may cause actual results,levels of activity, performance or achievements to differ materially fromresults expressed or implied by this press release. Such risk factors include,among others: the nature and extent of additional Adlea clinical trials thatmay be required by the FDA prior to Anesiva's submission of an application forapproval to market Adlea, whether any clinical trials will be successful, andthe ability to identify and successfully complete a strategic transaction forthe assets related to Zingo. Actual results may differ materially from thosecontained in the forward-looking statements in this press release. Additionalinformation concerning these and other risk factors is contained in Anesiva'sannual report on Form 10-K for the year ended December 31, 2007, and its mostrecent filing on Form 10-Q.
SOURCE Anesiva, Inc.