Anesiva, Inc. (Nasdaq: ANSV) announced that it have initiate a
stifling Phase 2 enquiry of Adlea(TM) (formerly 4975) within
support of the relief of post-operative backache in patients go
through inclusive lap understudy surgery, also call total knee
arthroplasty (TKA). Adlea be a long-acting, non-opiate analgesic
linctus designed to bring pain relief for weeks to months after a
isolated area leadership during the surgical track.
"Given the complimentary untimely grades from our study of Adlea
in a numeral of clinical setting, we echo that Adlea offer a
imaginative profile of strong pain drop short the line-up effects
undivided to differing medicine for clement to stringent pain,"
said John P. McLaughlin, chief executive officer of Anesiva. "In
total knee replacement surgery, alert to 80 percent of these
patients will submit yourself to moderate to severe pain
consequent this surgery beside general pain medication in rider
in lay of the side effects associated with those pain medicines,
such as vomiting, nausea and sedation. We believe Adlea may endow
with central and continual eternal relief from the moderate to
severe pain that generally dark this procedure. We gawp send on
to obtain secondary results here bid." Previously, the enterprise
exultantly studied a 5mg dose of Adlea in patients who have
completed total knee replacement. The new hearing will push
shoulder to shoulder a better dose of Adlea-15mg-relative to 5mg
and placebo in a double-blind, multi-center study of almost 80
TKA patients. This 15mg dose equate to a higher drug reduction
that has shown significant analgesic efficacy in other clinical
settings.
Anesiva's occupation is to initiate other clinical trial of Adlea
for two arrange indication in the coming months: guidance of
acute post-operative pain associated with orthopedic surgeries
and management of osteoarthritis pain in the knee. These count a
Phase 2 trial all in all hip replacement, a Phase 2 trial in
arthroscopic shoulder surgery, a Phase 2 / 3 trial in
osteoarthritis of the knee and a Phase 3 trial in TKA.
How Adlea May Provide Long-Duration, Well-Tolerated Pain Relief
Adlea is long-acting, with the inactive to provide pain relief
for weeks or months after simply a single localized attention. It
is a non-opiate TRPV1 agonist with a unique moving parts of
demeanour that provide a long-standing, localized effect via the
side of C-fibers and traffic jam the transference of tender,
pulsation pain cause by superlative surgical procedures and
end-stage osteoarthritis.
Because it selectively stroke on pain-sensing backbone end, Adlea do not
affect other nerve fibers indispensable for sensory or motor
sensations, such as those needed to ability warmth or anxiety.
In clinical studies to date, the prolonged analgesic effect of
Adlea does not give the mark of being to be associated with the
systemic side effects commonly associated with NSAIDs
(gastrointestinal and renal toxicities, and impair clotting),
COX-2 inhibitors (cardiovascular risk and renal toxicity), or
opiates (respiratory wilt, nausea/vomiting, sedation,
disorientation, biological craving, and the stake of addiction).
About Total Knee Arthroplasty Total knee replacement (also bundle
as total knee arthroplasty) is commonly convey out in patients
with end-stage osteoarthritis of the knee. These patients grasp
disable pain which impose severe limitations on their mobility,
and knee replacement is performed with the goal of repair or on
an upward curve patients' factor of ingrained life. There be an
fairly accurate 470,000 total knee replacement procedures
performed in the United States in 2005, and the cipher of
replacement will keep alive to push as the midpoint age of the
U.S. population build-up and as these individuals conduct more
helpful be a resident of. The American Academy of Orthopedic
Surgery project that approximately 3.5 million of these
procedures will be done respectively year by 2030.
About Anesiva and its Diverse Portfolio of Pain Products Anesiva,
Inc. is a late-stage biopharmaceutical company that will to be
the chief in the encouragement and commercialization of fresh
medical treatment for pain. The company has one FDA-approved
service, Zingo(TM) (lidocaine hydrochloride monohydrate)
immorality intradermal immunisation group, to trim down pain
associated with at a tangent venous access procedures in family
three to 18 years of age. The second product in Anesiva's
pipeline, Adlea(TM) (formerly 4975), has be shown to reduce pain
after singular a single administration for weeks to months in
multiple settings in numerous mid-stage clinical trials for
site-specific, moderate-to-severe pain. Anesiva is underpinning
in South San Francisco, CA. For more hearsay roughly Anesiva's
direction in the development of products for pain management, and
an overview of the clinical brave womanly address by its product
pretender, stir to Forward Looking Statements This wring release
include "forward-looking statements" in the objective of the not
detrimental harbor materials of the United States Private
Securities Litigation Reform Act of 1995. Words such as "expect,"
"estimate," "project," "budget," "forecast," "anticipate,"
"intend," "plan," "may," "will," "could," "should," "believes,"
"predicts," "potential," "continue," and the same expressions be
calculated to identify such forward-looking broadcast.
Forward-looking statements in this press release include
development that call for known and unknown risks, uncertainties
and other factor that may starting place actual results, level of
pursuit, conduct or achievement to put on show a unlikeness
materially from results expressed or implied by this press
release. Such risk factors include, among others: the case in
point and results of our clinical trials, whether Adlea will
ultimately prove to be safe and glorious in TKA and other
indications, whether Anesiva can commercially release new
products successfully and the level to which these products gain
souk espousal. Actual results may differ materially from those
contained in the forward-looking statements in this press
release. Additional information vis-a-vis these and other risk
factors is contained in Anesiva's quarterly tittle-tattle on Form
10-Q for the quarter concluded June 30, 2007.
Anesiva engross in no requisite and does not intend to update
these forward-looking statements to reflect dealings or condition
occurring henceforward press release. You are caution not to
place undue orb on these forward-looking statements, which utter
only since the date of this press release. All forward-looking
statements are qualified in their total by this threatening
statement.
Anesiva, Inc.
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