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 a highly significant reduction in
opioid medication consumption compared to placebo (p=0.005).
The Phase 3 TKA trial, known as ACTIVE-2 (Assessment of highly purified
Capsaicin To ImproVE pain management after orthopedic surgery), also showed
that Adlea's safety profile of adverse events, wound healing, and wound
sensory function were similar to placebo over the study duration.
Anesiva is based in South San Francisco, CA. For more information, go to
www.anesiva.com.
Forward-Looking Statements
This press release includes 'forward-looking statements' within the
meaning of the safe harbor provisions of the United States Private Securities
Litigation Reform Act of 1995. Words such as 'seek' and similar expressions
are intended to identify such forward-looking statements. Forward-looking
statements in this press release include matters that involve known and
unknown risks, uncertainties and other factors that may cause actual results,
levels of activity, performance or achievements to differ materially from
results expressed or implied by this press release. Such risk factors include,
among others: the nature and extent of additional Adlea clinical trials that
may be required by the FDA prior to Anesiva's submission of an application for
approval to market Adlea, whether any clinical trials will be successful, and
the ability to identify and successfully complete a strategic transaction for
the assets related to Zingo. Actual results may differ materially from those
contained in the forward-looking statements in this press release. Additional
information concerning these and other risk factors is contained in Anesiva's
annual report on Form 10-K for the year ended December 31, 2007, and its most
recent filing on Form 10-Q.
SOURCE Anesiva, Inc.
