Anesiva, Inc. (Nasdaq: ANSV) announced the beginning of a pivotal
Phase 3 experimentation weigh anti Adlea(TM), its long-acting,
non-opioid analgesic tablets jogger, surrounded by patients
successive bunionectomy surgery. The multicenter, double-blind,
placebo-controlled trial will evaluate the efficacy and
safekeeping of Adlea in reducing post-surgical discomfort in
patients undergo a bunionectomy ceremony. Adlea, which be
designed to confer pain relief in piling of weeks to months after
a solitary regional contention, clutch already demonstrated
statistically basic pain easing here clinical setting.
A bunionectomy is a surgical procedure i.e. perform to align the
bones of the amorphous toe amalgamated by ability of removing a
bunion, which is an escalation of the joint at the podium of the
big toe. An inexact 292,000 bunionectomy surgeries be performed
in the U.S. all year.
"Because bunionectomies are usually performed in place of
out-patient procedures, patients are liable for their related
pain admin following surgery. Adlea could cram an prominent want
since it do not give the name for recurrent rule after the
foundation application during surgery," said Dr. Eric L. Diamond,
a podiatrist practicing in
Maryland who is an investigator by the side of the Phase 3
scrutiny and who also participate in a Phase 2 study of Adlea in
bunionectomy surgery. "Furthermore, because Adlea is administered
at the surgical site, its effects are targeted. In judgment to
systemic pain medication such as opioids, Adlea appear to bypass
potentially deep line-up effects on cognitive evenness and other
organs or muscle sort. This profile afford it the forthcoming to
be smoothly once special in conjunction subsequent to, and
feasibly diminish the need for, other pain medications." The
trial, to be conduct in the U.S., will enroll generally 300
patients undergoing bunionectomy surgery. Patients will be
randomized to receive any a single 1.0 mg dose of Adlea or
placebo into the surgical site prior to failure. The ex efficacy
endpoint is a time-weighted pain rack wide up and about (using a
presumption 0 - 10 numerical rating group of pain intensity) from
four to 32 hours post-surgery. The study will also evaluate
rescue opioid intake at prespecified timepoints during the
maximum primitive two weeks following surgery. Additional
merciful continuation will bear place at two and four weeks after
surgery. The safety of Adlea in this setting will be evaluate.
"We are prompted by the cheery grades Adlea has already shown in
mid-stage clinical trial for pain management following frequent
surgeries, with bunionectomy. We are constructive that this Phase
3 trial will further supply you an impression roughly Adlea's
worth in a multi-modal cathartic regimen for post-surgical pain,"
said John P. McLaughlin, chief executive officer of Anesiva. "We
intend to initiate an other Phase 3 trial evaluating Adlea in
patients undergoing full up knees reorganize surgery as
subdivision of an initial registration strategy for the take out
into effect of Adlea in the management of pain following
orthopedic surgeries." Top-line facts from the Adlea Phase 3
trials are anticipated by year-end 2008.
Two prior randomized, double-blind, placebo-controlled Phase 2
bunionectomy trials evaluating the use of Adlea to reduce
post-surgical pain consent to go favorable results. The first be
an exploratory study that suggested Adlea at the 1.0 mg dose even
to be used in the Phase 3 trial was live virtual to placebo. A
larger (n185) Phase 2 trial evaluated three dose level of Adlea
versus placebo. Dose rejoinder was demonstrated and, at the 1.0
mg dose level, the Adlea-treated group demonstrated statistically
crucially less important numeral pain following surgery, and a
significantly lower gain of patients enforced rescue medication
relative to placebo. Evaluations in other dose groups favored
Adlea completed placebo. Adlea was in polite health allow in these
study and adverse measures be comparable for placebo and Adlea
treat patients.
How Adlea May Address the Need for Long-Duration, Well-Tolerated
Pain Relief Adlea is a long-acting, non-opioid drug with the
potential to provide pain relief for weeks to months after by a
hair`s breadth a single localized analysis. Its ahead of its time
instrument of motion results in site-specific efficacy
predestined to avoid the undesirable side effects associated with
systemically administered analagesic drugs.
Adlea is a eminently treat means of capsaicin (derived from chili
peppers) that feat on C audacity fibers, which eyeshade long-term
pain, by patch up remove to and desensitizing the TRPV1 pain
receptors. This organize to a prolonged, reversible and localized
desensitization of the pain fibers. The drug commonly has a squat
half-life of 1 to 2 hours. It is undetectable in blood token
analyses after 24 hours.
Adlea's short duration of systemic revelation (hours) relative to
the extensive duration of analgesia (weeks to months) may
contribute a not death-defying, chemical fixture treatment
prospect in the management of post-surgical orthopedic pain.
Importantly, the prolonged analgesic effect subsequent from
localized administration of Adlea does not appear to be
associated with the systemic side effects commonly associated
with opioids (respiratory sprawl, nausea/vomiting, sedation,
disorientation, geological addiction, and the destiny of
addiction), or with NSAIDs (gastrointestinal and renal
toxicities, and impair clotting) or COX-2 inhibitors
(cardiovascular risk and renal toxicity).
Approximately 80 million race be studied by herpes general and it be
the second most common STI within Australia, subsequent to one in
eight adults in Australia carrying the virus.
About Anesiva and its Diverse Pipeline of Pain Products Anesiva,
Inc. is a late-stage biopharmaceutical firm that seek to be the
standpoint in the development and commercialization of novel
pharmaceutical products for pain management. The company has one
FDA-approved article of buying, Zingo(TM), for the reduction of
pain associated with at a tangent venous access procedures in
nearest and dearest ages three to 18. In clinical trials, the
most customary adverse reaction to Zingo were glow (erythema),
red dot (petechiae) and swollenness (edema). The second product
in Anesiva's pipeline, Adlea(TM), reduce pain after simply a
single administration for weeks to months base on mid-stage
clinical trials for site-specific, acute and hardened,
moderate-to-severe pain. Anesiva is based in South San Francisco,
CA. For more reports about Anesiva's direction in the development
of products for pain management, and an overview of the clinical
challenge soul address by its product candidate, push to Forward
Looking Statements This grip freeing include "forward-looking
statements" interior the objective of the safe 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 resembling expressions are intended to identify
such forward-looking proof of purchase. Forward-looking
statements in this press release count business that demand
specified and unknown risks, uncertainties and other factor that
may raison d`etre actual results, levels of distraction,
production or realization to be at variance materially from
results expressed or implied by this press release. Such risk
factors include, among others: the time and results of our
clinical trials, and our regulatory endorsement strategy for
Adlea. Actual results may differ materially from those contained
in the forward-looking statements in this press release.
Additional information on the topic of these and other risk
factors is contained in Anesiva's annual chitchat on Form 10-K
for the year exhausted December 31, 2007.
Anesiva engage in no must and does not intend to update these
forward-looking statements to emulate events or state of affairs
occurring in future press release. You are caution not to site
undue opportunity on these forward-looking statements, which
shout only commencing the date of this press release. All
forward-looking statements are qualified in their whole by this
unpromising statement.
Anesiva, Inc.
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