MOUNTAIN VIEW, Calif.,
Aug. 14, 2014 /PRNewswire/
-- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) today provided
an update on its European Medicines Agency (EMA) post-approval
studies for ADASUVE® inhalation powder, pre-dispensed
(loxapine). As part of the ADASUVE approval process with the
EMA, Alexza is required to conduct five post-approval studies:
- a benzodiazepine interaction study - study completed and data
submitted to the EMA
- a controlled study to determine ADASUVE's effect on cardiac
rhythms, or a thorough QTc study, with two doses of ADASUVE - study
completed and data submitted to the EMA
- a clinical program designed to evaluate the safety / efficacy
of ADASUVE in agitated adolescent patients - the initial study in
this program, a Phase 1 dose-ranging study, has been initiated in
collaboration with Teva and the first patient dosed
- a Post-Authorization Safety Study (PASS) - study has been
initiated and the first patient dosed
- a Drug Utilization Study (DUS) - study planned to be initiated
in Q4 2014
"We are encouraged by the progress we are making on the EU
post-approval commitments for ADASUVE. We have already
completed two of the studies and submitted the data to the EMA,"
said James V. Cassella, PhD,
Executive Vice President, Research and Development and Chief
Scientific Officer of Alexza. "We are pleased that the first
patient in our PASS study and the first patient in our Phase 1
dose-ranging study have been dosed, and look forward to additional
patient enrollment in the three ADASUVE studies in the coming
months."
ADASUVE PASS Design
The EMA requested a PASS to better understand the safety profile of
ADASUVE in real-world use in Europe, and to assess effectiveness of the
risk minimization activities. This study is a multicenter,
multinational, prospective observational study to evaluate the
safety of ADASUVE when used in the routine clinical setting in
agitated patients. The study is intended to enroll
approximately 1,500 patients from a total of about 20 to 25 centers
in five to six EU countries over a 24-month enrollment period.
ADASUVE DUS Design
The EMA requested a DUS to evaluate the patterns of use for ADASUVE
in routine clinical practice in Europe. This multicenter, multinational
study entails retrospective review of medical records of patients
receiving ADASUVE in real-world settings. The study is
expected to include a total of approximately 1,000 patients from a
total of about 20 to 25 centers in five to six EU countries over an
18-month enrollment period.
About ADASUVE (Staccato® loxapine)
ADASUVE is the first and only oral inhalation therapy for the rapid
control of mild-to-moderate agitation in adult patients with
schizophrenia or bipolar disorder. The marketing
authorization for ADASUVE requires that patients receive regular
treatment immediately after administration of the product to
control acute agitation symptoms. It also requires that
ADASUVE be administered only in a hospital setting under the
supervision of a healthcare professional. Short-acting
beta-agonist bronchodilator treatment should be available for
treatment of possible severe respiratory side effects, such as
bronchospasm.
ADASUVE combines Alexza's proprietary Staccato system
with loxapine, an antipsychotic medicinal product. The
Staccato system is a hand-held inhaler that delivers a drug
aerosol to the deep lung that results in intravenous-like
pharmacokinetics and rapid systemic effect. For more information
about ADASUVE, including the Summary of Product Characteristics and
Patient Information Leaflet approved in the EU, please visit the
EMA website. For the full prescribing information including
boxed warnings for the U.S., please visit
www.adasuve.com.
Alexza and Ferrer estimate that as many as eight million adults
in the EU alone suffer from schizophrenia or bipolar
disorder1. Agitation is a common symptom for these
patients2, characterized by feelings of distress,
anxiety and loss of control.
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 and it has been
approved for sale by the U.S. Food and Drug
Administration, the European Commission and most recently in
Guatemala.
Teva Pharmaceuticals USA, Inc.,
a subsidiary of Teva Pharmaceutical Industries Ltd., is Alexza's
commercial partner for ADASUVE in the U.S. 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 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 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. 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.
References:
- Wittchen H.U., et al., 2011. The size and burden of
mental disorders and other disorders of the brain in Europe 2010. Eur. Neuropsychopharmacol. 21,
655-679.
- Alexza data on file (primary market research among caregivers
of patients with schizophrenia (95% have agitation) and bipolar
patients (87% have agitation).
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SOURCE Alexza Pharmaceuticals, Inc.