Welcome!

News Feed Item

Alexza Announces the U.S. Commercial Launch of ADASUVE® by Teva Pharmaceuticals

ADASUVE is the first and only orally inhaled medicine for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults

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.

Alexza Pharmaceuticals

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

Photo - http://photos.prnewswire.com/prnh/20140121/SF49110LOGO

SOURCE Alexza Pharmaceuticals, Inc.

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
LogMeIn has completed its previously disclosed merger with Citrix Systems, Inc.’s GetGo, Inc. subsidiary, a wholly owned subsidiary consisting of Citrix’s GoTo family of service offerings. The merger officially closed after market hours on January 31, 2017. Effected through a Reverse Morris Trust transaction, the merger brings together two of the preeminent players in cloud connectivity to instantly create one of the world’s top 10 public SaaS companies, and a market leader with the scale, resou...
DevOps tends to focus on the relationship between Dev and Ops, putting an emphasis on the ops and application infrastructure. But that’s changing with microservices architectures. In her session at DevOps Summit, Lori MacVittie, Evangelist for F5 Networks, will focus on how microservices are changing the underlying architectures needed to scale, secure and deliver applications based on highly distributed (micro) services and why that means an expansion into “the network” for DevOps.
SYS-CON Events announced today that Hitrons Solutions will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Hitrons Solutions Inc. is distributor in the North American market for unique products and services of small and medium-size businesses, including cloud services and solutions, SEO marketing platforms, and mobile applications.
Ayehu provides IT Process Automation & Orchestration solutions for IT and Security professionals to identify and resolve critical incidents and enable rapid containment, eradication, and recovery from cyber security breaches. Ayehu provides customers greater control over IT infrastructure through automation. Ayehu solutions have been deployed by major enterprises worldwide, and currently, support thousands of IT processes across the globe. The company has offices in New York, California, and Isr...
Whether they’re located in a public, private, or hybrid cloud environment, cloud technologies are constantly evolving. While the innovation is exciting, the end mission of delivering business value and rapidly producing incremental product features is paramount. In his session at @DevOpsSummit at 19th Cloud Expo, Kiran Chitturi, CTO Architect at Sungard AS, discussed DevOps culture, its evolution of frameworks and technologies, and how it is achieving maturity. He also covered various styles and...
SYS-CON Events announced today that Catchpoint Systems, Inc., a provider of innovative web and infrastructure monitoring solutions, has been named “Silver Sponsor” of SYS-CON's DevOps Summit at 18th Cloud Expo New York, which will take place June 7-9, 2016, at the Javits Center in New York City, NY. Catchpoint is a leading Digital Performance Analytics company that provides unparalleled insight into customer-critical services to help consistently deliver an amazing customer experience. Designed ...
SYS-CON Events announced today that MobiDev, a client-oriented software development company, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place June 6-8, 2017, at the Javits Center in New York City, NY, and the 21st International Cloud Expo®, which will take place October 31-November 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. MobiDev is a software company that develops and delivers turn-key mobile apps, websites, web services, and complex softw...
In his General Session at 17th Cloud Expo, Bruce Swann, Senior Product Marketing Manager for Adobe Campaign, explored the key ingredients of cross-channel marketing in a digital world. Learn how the Adobe Marketing Cloud can help marketers embrace opportunities for personalized, relevant and real-time customer engagement across offline (direct mail, point of sale, call center) and digital (email, website, SMS, mobile apps, social networks, connected objects).
Why do your mobile transformations need to happen today? Mobile is the strategy that enterprise transformation centers on to drive customer engagement. In his general session at @ThingsExpo, Roger Woods, Director, Mobile Product & Strategy – Adobe Marketing Cloud, covered key IoT and mobile trends that are forcing mobile transformation, key components of a solid mobile strategy and explored how brands are effectively driving mobile change throughout the enterprise.
More and more brands have jumped on the IoT bandwagon. We have an excess of wearables – activity trackers, smartwatches, smart glasses and sneakers, and more that track seemingly endless datapoints. However, most consumers have no idea what “IoT” means. Creating more wearables that track data shouldn't be the aim of brands; delivering meaningful, tangible relevance to their users should be. We're in a period in which the IoT pendulum is still swinging. Initially, it swung toward "smart for smart...
DevOps is often described as a combination of technology and culture. Without both, DevOps isn't complete. However, applying the culture to outdated technology is a recipe for disaster; as response times grow and connections between teams are delayed by technology, the culture will die. A Nutanix Enterprise Cloud has many benefits that provide the needed base for a true DevOps paradigm.
SYS-CON Events announced today that Technologic Systems Inc., an embedded systems solutions company, will exhibit at SYS-CON's @ThingsExpo, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Technologic Systems is an embedded systems company with headquarters in Fountain Hills, Arizona. They have been in business for 32 years, helping more than 8,000 OEM customers and building over a hundred COTS products that have never been discontinued. Technologic Systems’ pr...
To manage complex web services with lots of calls to the cloud, many businesses have invested in Application Performance Management (APM) and Network Performance Management (NPM) tools. Together APM and NPM tools are essential aids in improving a business's infrastructure required to support an effective web experience... but they are missing a critical component - Internet visibility.
"We provide DevOps solutions. We also partner with some key players in the DevOps space and we use the technology that we partner with to engineer custom solutions for different organizations," stated Himanshu Chhetri, CTO of Addteq, in this SYS-CON.tv interview at DevOps at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Tintri VM-aware storage is the simplest for virtualized applications and cloud. Organizations including GE, Toyota, United Healthcare, NASA and 6 of the Fortune 15 have said "No to LUNs." With Tintri they manage only virtual machines, in a fraction of the footprint and at far lower cost than conventional storage. Tintri offers the choice of all-flash or hybrid-flash platform, converged or stand-alone structure and any hypervisor. Rather than obsess with storage, leaders focus on the business app...