MOUNTAIN VIEW, Calif.,
March 3, 2014 /PRNewswire/ -- Alexza
Pharmaceuticals, Inc. (Nasdaq: ALXA) today announced the U.S.
commercial launch of ADASUVE® (loxapine) inhalation
powder 10mg by its commercial partner, Teva Pharmaceutical
Industries Ltd., (NYSE: TEVA). ADASUVE is the first and only
orally inhaled medicine for the acute treatment of agitation
associated with schizophrenia or bipolar I disorder in adults.
ADASUVE is administered through our innovative proprietary
Staccato® single-use, hand held drug delivery technology
system. This new drug-device combination product provides rapid
systemic delivery by inhalation of a thermally-generated aerosol of
loxapine, a first generation antipsychotic, to the lung.
Administration of ADASUVE results in rapid absorption of loxapine,
with a maximum plasma concentration achieved in approximately 2
minutes.
"ADASUVE is the first product approved in the U.S. in an orally
inhaled formulation that provides a treatment option with fast
onset for adults with agitation associated with schizophrenia or
bipolar I disorder. The launch of ADASUVE represents an
important milestone for Alexza and the millions of patients with
schizophrenia or bipolar I disorder who seek treatment for their
agitation episodes each year," said Thomas
B. King, President and CEO of Alexza. "We have
successfully taken a Staccato-based product from concept
through development, approval and manufacturing scale-up."
King continued, "We believe Teva is an excellent commercial
partner for ADASUVE in the U.S. and we are confident of their
commercial capabilities. We look forward to continuing our
support of their launch efforts in the U.S."
Teva licensed the U.S. commercial rights to ADASUVE in
May 2013 from Alexza. Under the
terms of the license and supply agreement, Teva is responsible for
all U.S. commercial and clinical activities for ADASUVE, including
U.S. post-approval clinical studies. Alexza is responsible
for manufacturing and supplying ADASUVE to Teva for commercial
sales and clinical trials. Alexza is eligible to receive
tiered royalty payments based on net commercial sales of ADASUVE,
as well as certain milestone payments, based upon successful
completion of the ADASUVE post-approval studies in the U.S and the
achievement of net sales targets.
Efficacy was demonstrated in two clinical trials in acute
agitation: one in schizophrenia and one in bipolar I disorder.
Patients receiving ADASUVE experienced a statistically significant
reduction in agitation at two hours, with an effect seen as early
as ten minutes post-dose.
Due to the risk of bronchospasm that has the potential to lead
to respiratory distress and respiratory arrest, ADASUVE is
contraindicated in patients with a current diagnosis or history of
asthma, chronic obstructive pulmonary disease (COPD), or other
pulmonary disease associated with bronchospasm and is only
available through a restricted program called the ADASUVE Risk
Evaluation and Mitigation Strategy (REMS). ADASUVE must be
administered only in a REMS-enrolled healthcare facility that has
immediate access on-site to equipment and personnel trained to
manage acute bronchospasm, including advanced airway management
(intubation and mechanical ventilation).
"Existing treatment options for patients with agitation
associated with schizophrenia or bipolar I disorder are limited to
oral tablets or injectable modes of administration, sometimes
requiring the use of restraints," said Richard Jaffe, M.D., Medical Director for
Research and Clinical Trials at the Belmont Center for
Comprehensive Treatment Philadelphia,
Pennsylvania, and a clinical trial investigator." ADASUVE is
a drug-device combination that offers health care providers a new
option to help manage agitation."
In the United States,
approximately 2.4 million adults have schizophrenia and
approximately 5.7 million adults have bipolar disorder. More
than 90% of patients with schizophrenia or bipolar disorder will
experience agitation in their lifetimes.i
Patients experiencing agitation associated with
schizophrenia or bipolar I disorder often manifest behaviors that
interfere with their care, such as threatening behaviors,
escalating or urgently distressing behavior or self-exhausting
behavior that lead clinicians to use rapidly absorbed antipsychotic
medications to help control the agitation quickly.
"The availability of orally inhaled ADASUVE provides a rapid
onset of action that quickly improves symptoms for patients, and
gives providers in enrolled hospitals another treatment choice,"
said Michael McHugh, Vice President
and General Manager, Teva Select Brands and Teva Women's Health. "As part of our
ongoing commitment to enhancing patient care and bringing new
therapies and delivery systems to the market that fit within our
areas of expertise, Teva is pleased to launch this new treatment
choice that is aligned with Teva's New Therapeutic Entities (NTE)
program."
Two Phase 3 short-term clinical efficacy trials demonstrated
significant improvement in agitation at two hours, in patients with
schizophrenia or bipolar I disorder treated with ADASUVE.
These studies demonstrated a 49% reduction in
agitation symptoms from baseline in schizophrenia patients, as
compared to 33% in placebo, and 53% reduction in bipolar I
patients, as compared to 27% in placebo. Improvement was
rapidly achieved at 10 minutes post-dose with a 19% reduction in
agitation symptoms from baseline in schizophrenia patients and a
23% reduction in bipolar I patients, both as compared to 10% in
placebo.
Please see additional important safety information including
boxed warnings and REMS Program information below. The most
common adverse reactions (greater than at least 2% in the treated
group and greater than in the placebo group) in short-term,
placebo-controlled trials were dysgeusia (abnormal taste), sedation
and throat irritation.
ADASUVE is currently available through a select distribution
network. Please call (800) 292-4283 or visit www.ADASUVE.com
for additional information.
ADASUVE® Prescribing Information (U.S.)
Please click here for Full Prescribing
Information, including Boxed WARNINGS.
For more information about ADASUVE, visit
www.ADASUVE.com
For REMS Program information, visit
www.ADASUVEREMS.com or call (855)-755-0492
INDICATIONS AND USAGE
ADASUVE (loxapine) inhalation
powder, for oral inhalation use, is a typical antipsychotic
indicated for the acute treatment of agitation associated with
schizophrenia or bipolar I disorder in adults. Efficacy was
demonstrated in 2 trials in acute agitation: one in schizophrenia
and one in bipolar I disorder.
Limitations of Use: As part of the ADASUVE REMS Program to
mitigate the risk of bronchospasm, ADASUVE must be administered
only in an enrolled healthcare facility.
IMPORTANT SAFETY INFORMATION
|
WARNING:
BRONCHOSPASM and
|
INCREASED
MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS
|
Bronchospasm
|
ADASUVE can cause
bronchospasm that has the potential to lead to respiratory distress
and respiratory arrest. Administer ADASUVE only in an enrolled
healthcare facility that has immediate access on-site to equipment
and personnel trained to manage acute bronchospasm, including
advanced airway management (intubation and mechanical ventilation).
Prior to administering ADASUVE, screen patients regarding a current
diagnosis, history, or symptoms of asthma, COPD and other lung
diseases, and examine (including chest auscultation) patients for
respiratory signs. Monitor for signs and symptoms of bronchospasm
following treatment with ADASUVE.
|
|
Because of the
risk of bronchospasm, ADASUVE is available only through a
restricted program under a Risk Evaluation and Mitigation Strategy
(REMS) called the ADASUVE REMS.
|
|
Increased
Mortality in Elderly Patients With Dementia-Related
Psychosis
|
Elderly patients
with dementia-related psychosis treated with antipsychotic drugs
are at an increased risk of death. ADASUVE is not approved for the
treatment of patients with dementia-related
psychosis.
|
- ADASUVE is contraindicated in patients with the following:
- Current diagnosis or history of asthma, COPD, or other lung
disease associated with bronchospasm
- Acute respiratory signs/symptoms (eg, wheezing)
- Current use of medications to treat airways disease, such as
asthma or COPD
- History of bronchospasm following ADASUVE treatment
- Known hypersensitivity to loxapine or amoxapine. Serious skin
reactions have occurred with oral
- loxapine and amoxapine
- ADASUVE must be administered only by a healthcare
professional
- Prior to administration, all patients must be screened for a
history of pulmonary disease and examined (including chest
auscultation) for respiratory abnormalities (eg, wheezing)
- Administer only a single 10 mg dose of ADASUVE within a 24-hour
period by oral inhalation using the single-use inhaler
- After ADASUVE administration, patients must be monitored for
signs and symptoms of bronchospasm at least every 15 minutes for at
least 1 hour
- ADASUVE can cause sedation, which can mask the symptoms
of bronchospasm
- Antipsychotic drugs can cause a potentially fatal symptom
complex called Neuroleptic Malignant Syndrome (NMS), manifested by
hyperpyrexia, muscle rigidity, altered mental state, irregular
pulse or blood pressure, tachycardia, diaphoresis, and cardiac
dysrhythmia. Associated features can include escalated serum
creatine phosphokinase (CPK) concentration, rhabdomyolysis,
elevated serum and urine myoglobin concentration, and renal
failure. If NMS occurs, immediately discontinue antipsychotic drugs
and other drugs that may contribute to the underlying disorder,
monitor and treat symptoms, and treat any concomitant serious
medical problems
- ADASUVE can cause hypotension, orthostatic hypotension, and
syncope. Use with caution in patients with known cardiovascular
disease, cerebrovascular disease, or conditions that would
predispose patients to hypotension. In the presence of severe
hypotension requiring vasopressor therapy, epinephrine should not
be used
- Use ADASUVE with caution in patients with a history of seizures
or with conditions that lower the seizure threshold. ADASUVE lowers
the seizure threshold. Seizures have occurred in patients treated
with oral loxapine and can also occur in epileptic patients
- Use caution when driving or operating machinery. ADASUVE can
impair judgment, thinking, and motor skills
- The potential for cognitive and motor impairment is increased
when ADASUVE is administered concurrently with other CNS
depressants
- Treatment with antipsychotic drugs caused an increased
incidence of stroke and transient ischemic attack in elderly
patients with dementia-related psychosis; ADASUVE is not approved
for the treatment of patients with dementia-related psychosis
- Use of ADASUVE may exacerbate glaucoma or cause urinary
retention
- The most common adverse reactions (incidence ≥2% and greater
than placebo) in clinical studies in patients with agitation
treated with ADASUVE were dysgeusia, sedation, and throat
irritation
- Pregnancy Category C. Neonates exposed to antipsychotic drugs
during the third trimester of pregnancy are at risk of
extrapyramidal and/or withdrawal symptoms after delivery. ADASUVE
should be used during pregnancy only if the potential benefit
justifies the potential risk to the fetus
- Nursing mothers: Discontinue drug or nursing, taking into
account the importance of the drug to the mother
- The safety and effectiveness of ADASUVE in pediatric patients
have not been established
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.
ADASUVE (Staccato loxapine) is Alexza's first commercial
product, which was approved by the U.S. Food and Drug
Administration in December 2012 and
by the European Commission in February
2013. Teva Pharmaceuticals USA, Inc. is Alexza's commercial partner for
ADASUVE in the U.S. Grupo Ferrer Internacional, S.A. is Alexza's
commercial partner for ADASUVE in Europe, Latin
America, Russia and the
Commonwealth of Independent States countries.
ADASUVE® and Staccato® are registered
trademarks of Alexza Pharmaceuticals, Inc.
Safe Harbor Statement
This news 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 its U.S. commercial partner, Teva 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. 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, 2012 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.
i Alexza – data on file
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SOURCE Alexza Pharmaceuticals, Inc.