Alexza Pharmaceuticals Provides an Update on the Five Post-EMA Approval Studies for ADASUVE®
First Patient Dosed in the EU Post-Authorization Safety Study
First Patient Dosed in the Phase 1 Study in Adolescent Patients
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.
- 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).
SOURCE Alexza Pharmaceuticals, Inc.