MOUNTAIN VIEW, Calif.,
Jan. 22, 2015 /PRNewswire/
-- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today
that it has initiated a Phase 2a study of AZ-002
(Staccato® alprazolam), which is being developed for the
management of epilepsy in patients with acute repetitive seizures
(ARS). ARS occurs in a subset of patients with epilepsy who
regularly experience breakthrough seizures, despite treatment with
a regular regimen of anti-epileptic drugs.
"Our team has been working with some of the leading opinion
leaders in the field of epilepsy to finalize our development
strategy for AZ-002," said James V.
Cassella, PhD, Executive Vice President, Research and
Development, and Chief Scientific Officer of Alexza. "We
believe that AZ-002, if approved, could greatly benefit epilepsy
patients who experience seizure emergencies like ARS."
Dr. Cassella continued, "In previous clinical studies where we
have dosed more than 100 subjects, Staccato alprazolam
demonstrated excellent dose-proportionality, exhibited a median
Tmax (time to peak plasma concentration) of 2 minutes,
and was safe and well-tolerated."
Acute Repetitive Seizures (ARS)
Epilepsy, a disorder of recurrent seizures, affects approximately
2.5 million Americans, making it the third most common
neurological disorder in the United States. ARS refers to
seizures that are serial, clustered or crescendo, and ones that are
distinct from the patient's usual seizure pattern. Typically
there is recovery between the seizures in the
cluster1.
Among the implications of ARS are concerns for patient safety.
Seizure effects generally correlate directly with seizure
duration. Prolonged or recurrent seizure activity persisting
for 30 minutes or more may result in serious injury, health
impacts or death. If left untreated, ARS has been reported to
evolve into status epilepticus, a life-threatening condition in
which the brain is in a state of persistent seizure which has a
mortality rate of 3% in children and 26% in
adults.2
Benzodiazepines are considered to be medications of first choice
for the treatment of ARS. The most immediate treatment for
out-of-hospital care and the only U.S. Food and Drug
Administration-approved product for acute repetitive seizures is
rectal diazepam gel. This treatment may produce central nervous
system depression. Oral, buccal, and sublingual
benzodiazepines (lorazepam, diazepam), which are not approved for
patients with ARS, are sometimes used for treatment, but only if
the risk of aspiration is not a concern and it is recognized that
the absorption time will be increased. Nasal benzodiazepine
products, available in some countries, are not yet available in the
United States. Intravenous benzodiazepines are rapidly acting,
but must be administered by a healthcare professional in a medical
facility.
The ability to treat a patient quickly is clinically imperative
to avoid the epilepsy becoming status epilepticus or causing other
serious complications3. Alexza believes that a product
that can be administered easily in the home setting to effectively
treat ARS may result in avoiding a trip to the hospital for
treatment or diminish the use of the rectal formulation of
diazepam. AZ-002 could be administered after the first seizure in a
cluster, with the aim of preventing further seizures. The
caregiver could provide dosing assistance between
seizures. The product could also be used in a healthcare
facility, thus avoiding the use of an IV or a rectal formulation of
a benzodiazepine.
AZ-002 Study Design
Alexza's AZ-002 Phase 2a study is an in-clinic, randomized,
placebo-controlled, double-blind evaluation of patients with
epilepsy using the intermittent photo-stimulation model. The
primary aim of this study is to assess the safety and the
pharmacodynamic electroencephalographic effects of a single dose of
AZ-002 at different dose strengths vs. placebo. Data from this
clinical trial are expected to serve as the basis for dose
selection in potential future efficacy and safety clinical studies
and will be collected from three clinical trial sites.
While there are not firm incidence and prevalence numbers in the
literature, there are estimated to be about 150,0004
people with ARS in the United
States, which could make AZ-002 eligible for orphan product
status.
Alexza expects to announce results from this study in the first
half of 2015. More information on this Phase 2a study can
be found at www.clinicaltrials.gov. Alexza owns full development
and commercial rights to AZ-002.
About Alexza Pharmaceuticals, Inc.
Alexza Pharmaceuticals is focused on the research, development and
commercialization of novel, proprietary products for the acute
treatment of central nervous system conditions. Alexza's products
are based on the Staccato system, a hand-held inhaler
designed to deliver a drug aerosol to the deep lung, providing
rapid systemic delivery and therapeutic onset, in a
simple, non-invasive manner. For more information, visit
www.alexza.com.
ADASUVE is Alexza's first commercial product, is based on the
Staccato technology, and has been approved for sale by the
U.S. Food and Drug Administration, the European Commission,
and in several Latin American countries.
Teva Pharmaceuticals USA, Inc.,
a subsidiary of Teva Pharmaceutical Industries Ltd., is Alexza's
commercial partner for ADASUVE in the United States. Grupo
Ferrer Internacional SA is Alexza's commercial partner for ADASUVE
in Europe, Latin America, and the Commonwealth of
Independent States countries.
ADASUVE® and Staccato® are registered
trademarks of Alexza Pharmaceuticals, Inc.
Safe Harbor Statement
This press release contains
forward-looking statements that involve significant risks and
uncertainties. Any statement describing the Company's expectations
or beliefs is a forward-looking 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
certain risks and uncertainties, particularly those inherent in the
process of developing and commercializing drugs, including the
ability of Alexza and our partners, Teva and Ferrer, to effectively
and profitably commercialize ADASUVE, estimated product revenues
and royalties associated with the sale of ADASUVE, the adequacy of
the Company's capital to support the Company's operations, and the
Company's ability to raise additional funds and the potential terms
of such potential financings, whether the Company's financial
resources will be sufficient to meet its business objectives and
operational requirements to manufacture ADASUVE and to develop
AZ-002, results of studies and trials may not be predictive of the
future clinical trial results of AZ-002 or other product
candidates, the protection and market exclusivity provided by the
Company's intellectual property for its product candidates,
including rights to AZ-002, and the impact of competitive products
and technological changes. The Company's forward-looking statements
also involve assumptions that, if they prove incorrect, would cause
its results to differ materially from those expressed or implied by
such forward-looking statements. These and other risks concerning
Alexza's business are described in additional detail in the
Company's Annual Report on Form 10-K for the year ended
December 31, 2013 and the Company's
other Periodic and Current Reports filed with the Securities and
Exchange Commission. Forward-looking statements contained in this
announcement are made as of this date, and the Company undertakes
no obligation to publicly update any forward-looking statement,
whether as a result of new information, future events or
otherwise.
Reference:
1. Cereghino, JJ., 2007. Identification and
treatment of acute repetitive seizures in children and adults
2. Boggs, J., 2004. Mortality Associated
with Status Epilepticus
3. Dreifuss, Fritz E., 1998. Comparison of
Rectal Diazepam Gel and Placebo for Acute Repetitive Seizures
4. Alexza data on file
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SOURCE Alexza Pharmaceuticals, Inc.