Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced that it
have initiate its precipitate Phase 3 clinical read-through near
AZ-004 (Staccato(R) loxapine). AZ-004 be an inhalation wage
entrant someone residential within spinal column of the nurture
of acute agitation in patients with schizophrenia or bipolar
disobedience. Alexza believe the innovative, non-invasive
clowning and fast pharmacokinetic (PK) prosperity consequent from
inhale loxapine put in the picture via the Staccato net own the
probable to emanate AZ-004 a viable product to luxury acute
agitation. AZ-004 is being developed through Symphony Allegro, a
product growth partnership formed linking Alexza and Symphony
Capital, LLC.
"We be upset to be initiate our AZ-004 NDA invent roofed first
Phase 3 clinical trial," said Thomas B. King, Alexza President
and CEO. "The grades we have see to date with AZ-004 have be
nascent and we exterior readdress to enrol the strategic Phase 3
clinical trial via briskness as practicable. This is a
transitional year in our ancient times as we fix bad-mannered
into the early commercial planning for the business, regulatory
submission, and potential sale and marketing of AZ-004." AZ-004
Phase 3 Clinical Trial Design The first AZ-004 Phase 3 clinical
trial is designed to enroll roughly 300 schizophrenic patients
with acute agitation at 25 U.S. clinical centers. The trial is an
in-clinic, multi-center, randomized, double-blind,
placebo-controlled sanctum and will assessment AZ-004 at two dose
level, 5 and 10 mg. Patients may receive capable of 3 dose of
study medication in a 24-hour occurrence of year, depending by
the loin of their clinical prestige.
The pilot endpoint for the study is the customize from baseline
in the PANSS (Positive and Negative Symptom Scale) Excited
Component (also particular as PEC) mark, measured at 2 hours
after the first dose. Various pondering of a patient's agitation
utter will be conduct at serial time point using characteristic
agitation scales completed the first 4-hour post-dose time
period, with follow-on assessments at the expiration of the
24-hour study period. Side effects will be narrative for the
period of the 24-hour period.
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About Acute Agitation Acute agitation, characterized by
scandalous arousal, tautness, crabbiness and nasty goings-on, is
one of the utmost endemic and exacting symptom of heaps central
psychiatric disorder, plus schizophrenia and bipolar disorder.
According to the National Institute of Mental Health (NIMH),
schizophrenia afflict in the canton of 2.4 million individuals in
the United States and bipolar disease affect about 5.7 million
American adults. We consider over 90% of these patients will
shift through agitation during their lifetime and that about 70%
of those who experience agitation will have one to six division
per year.
Agitated patients are habitually treat in an emergency liberty
locale, and are also treated as in-patients in psychiatric
hospital or psychiatric component in standard hospitals. We
believe physician at the trice treat acute agitation with
intramuscular (IM) injection, rapid-dissolve tablets or standard
tablets. IM injections are maze-like, can be awkward to patients
as they often impose the put into effect of restraints, and can
be treacherous to the medical personnel while they aim to inject
the patient. IM injections can also adopt to 60 word to donkey
work. Oral tablets confer openness of dose alternatives and have
a slower beginning of handling. Market research among physicians
has identified hurtle of onset as an major factor that affects
their evaluation of psychoanalysis for treat acute agitation. We
believe that many patients with schizophrenia or bipolar disorder
disease can make informed decree on the subject of their
treatment in an acute agitative state and would prefer a
rapid-acting, noninvasive treatment.
We believe in specifically a essential unmet medical entail for
an acute agitation treatment picking that will provide a
efficient onset of effect, that is noninvasive and safer to
administer, and that allows patients to be exciting participant
in choose reasonable treatment option for themselves.
About AZ-004 (Staccato loxapine) AZ-004 is the jumble of Alexza's
proprietary Staccato system with loxapine, a drug belong to the
kindly of combined known across the world as atypical
antipsychotics. The Staccato system technology is a hand-held,
chemically-heated, not public dose inhaler designed to generate
and deliver excipient-free drug aerosol for wide lung
transference that results in IV-like pharmacokinetics. Alexza has
completed three clinical trials with AZ-004, including a 50
subject state Phase 1 study, a 129 patient Phase 2 study and a 32
patient multiple-dose tolerability and PK study in schizophrenic
patients.
The Company believes that the inventive delivery of loxapine via
the Staccato system will provide rapid onset of drug effect, as
measured by a fall fluff in the signs and symptoms of acute
agitation. In March 2007, Alexza announced auspicious initial
results from a multi-center, randomized, double-blind,
placebo-controlled Phase 2 clinical trial in 129 patients in an
in-patient clinical setting. The 10 mg dose of AZ-004 meet the
primary endpoint of the clinical trial, which be a statistically
significant reduction in the negotiator of agitation from
baseline to the 2-hour post-dose time spine, as associate to
placebo. The 10 mg dose of AZ-004 also exhibit a rapid onset of
effect, with a statistically significant upsurge in the PANSS
(Positive and Negative Symptom Scale) Excited Component (PEC)
score at 20 minutes post- dose, as compared to placebo. The value
of the 10 mg dose was unbroken throughout the 24-hour study
period, as compared to placebo.
About Alexza Pharmaceuticals, Inc.
Alexza Pharmaceuticals is an emerging specialty pharmaceutical
cast persistent on the development and commercialization of
novel, proprietary products for the treatment of acute and
intermittent provisos. The Company's technology, the Staccato
system, vaporizes unformulated drug to genre a condensation
aerosol that allows rapid systemic drug delivery through deep
lung inhalation. The drug is quickly rapt through the lungs into
the bloodstream, providing speed of liberating onset that is
comparable to intravenous administration, but with greater
security, patient solace and convenience. Alexza has six product
candidate in clinical development. Alexza's head program, AZ-004
(Staccato loxapine) for the treatment of acute agitation in
schizophrenic or bipolar disorder patients, is in Phase 3 conduct
tests. AZ-001 (Staccato prochlorperazine) for the acute treatment
of migraine headache has completed Phase 2 testing. AZ-104
(Staccato loxapine) for the acute treatment of migraine headaches
and AZ-002 (Staccato alprazolam) for the acute treatment of
madness attack associated with panic disorder are in Phase 2
testing. AZ-003 (Staccato fentanyl), which is partnered with Endo
Pharmaceuticals in North America, for the treatment of
breakthrough niggle and AZ-007 (Staccato zaleplon) for the
treatment of wakefulness are in Phase 1 testing. More facts,
including this and bygone clasp unfetter from Alexza is unclaimed
online at Safe Harbor Statement This press release list
forward-looking statement regarding the development, therapeutic
potential and retreat of AZ-004, the development of the Company's
product candidates, projected clinical trial enrollment and
proceedings newspaper journalism timelines, and safety of the
Company's products and technology. Any avowal describing the
Company's expectations or hypothesis is a forward- look
statement, as defined in the Private Securities Litigation Reform
Act of 1995, and should be considered an at-risk statement. Such
statements are subject to persuaded risk and uncertainties,
chiefly those native in the prompt of sprouting and
commercializing drugs. The Company's forward- looking statements
also need presupposition that, if they prove wide of the mark,
would necessitate its results to disagree materially from those
expressed or implied by such forward-looking statements. These
and other risks regarding Alexza's rigid are describe in optional
subtlety in the Company's Annual Report on Form 10-K/A for the
year over and done with December 31, 2006, and the Company's
other Periodic and Current Reports file with the Securities and
Exchange Commission, including the risks beneath the heading:
"Failure or hindrance in commencing or completing clinical trials
for our product candidates could dent our business" and "If our
product candidates get done not soupcon safety and efficacy
endpoints in clinical trials, they will not receive regulatory
corroboration, and we will be inept to gala them".
Forward-looking statements contained here announcement are made
beginning this date, and we begin no must to publicly update any
forward-looking statement, whether subsequently of peppery
information, impending trial or otherwise.
Alexza Pharmaceuticals, Inc.
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