Galen US Inc. Acquires First Inhaled Therapy Approved to Treat Agitation Associated with Schizophrenia and Bipolar I Disorder, Announces Revised Labeling

ADASUVE® (loxapine) inhalation powder is the first and only orally inhaled medicine approved for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults


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SOUDERTON, Pa.--()--Galen US Inc. today announced its acquisition of the US commercial rights to ADASUVE®, an orally inhaled form of the typical antipsychotic loxapine, from Alexza Pharmaceuticals, Inc. ADASUVE is the first and only FDA-approved inhaled therapy for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.1 ADASUVE offers a novel solution which allows for rapid systemic delivery by inhalation of a thermally-generated aerosol of loxapine to the lung.

“We are excited to add ADASUVE to Galen’s comprehensive product portfolio as we continue to increase our US footprint,” says Andrew Shales, General Manager at Galen US Inc. “ADASUVE will be our first priority for the foreseeable future because it is the only FDA-approved inhaled product for patients suffering escalating agitation associated with schizophrenia or bipolar I disorder. While other products are prescribed for this disorder, the only other agents approved for acute agitation in these patients are antipsychotics delivered via intramuscular injection, which is typically reserved for severely agitated patients. ADASUVE is a fast-acting first-line treatment which is non-invasive. Galen is proud to provide ADASUVE as an alternative option to serve both healthcare providers and patients.”

ADASUVE will now be available to a wider range of patients in more settings, such as Psychiatric Emergency Services (PES), as a result of recent FDA approved changes to the product labeling and the ADASUVE Risk Evaluation and Mitigation Strategy (REMS) Program. Galen will also expand distribution for the product increasing the availability of ADASUVE for hospital Emergency Departments (EDs) and psychiatric centers. ADASUVE must be administered only in a REMS enrolled healthcare facility.1

“Agitated patients present a significant challenge to emergency department personnel, making it imperative that caregivers can address the situation before it escalates into aggressive behavior,” says Scott L. Zeller, MD, Assistant Clinical Professor of Psychiatry, University of California-Riverside. “Medical staff in the ED work under pressure, and the potential for escalation into aggressive behavior puts staff and other patients at risk. An inhaled pharmacologic approach that produces rapid onset in a non-invasive manner has the potential to improve patients’ experiences, their cooperation with healthcare providers and outcomes.”

Agitation can rapidly escalate to potentially dangerous behaviors if not recognized early and managed effectively,2 and it is a common reason for patients with schizophrenia or bipolar I disorder to present at an ED or PES. ADASUVE offers an effective, rapid-acting, non-invasive, patient-centric approach that complements current psychiatric practices for de-escalating and managing agitation associated with schizophrenia or bipolar I disorder. In two pivotal Phase III clinical trials with adult patients with schizophrenia or bipolar I disorder, ADASUVE resulted in a statistically significant reduction in agitation at first measure, in just 10 minutes.1,3,4 A single 10 mg dose (in 24 hours) is easily administered by a healthcare professional 1 through a proprietary single-use, handheld, drug-delivery Staccato® technology that requires just one simple breath from the patient to activate the device. Staccato is a registered trademark of Alexza.

“Alexza’s collaboration with Galen represents an important milestone for the millions of patients with schizophrenia or bipolar I disorder who seek treatment for their episodes of agitation every year,” says Dr. Tatjana Naranda, President and COO of Alexza Pharmaceuticals, Inc., developers of the technology behind ADASUVE. “ADASUVE is an effective product. Early feedback from physicians and patients corroborate the positive clinical profile we observed with ADASUVE during its clinical development. It is an innovative medicine that provides an important option for physicians who treat patients with agitation associated with schizophrenia or bipolar I disorder.”


Established in 1968, Galen is a privately owned pharmaceutical sales and marketing company, headquartered in Craigavon (Northern Ireland), with products in therapy areas including gastroenterology, urology, female health, pain management and mental health. As a subsidiary of Galen Limited, Galen US also has a growing presence in select conditions requiring topical anesthesia and Central Nervous System disorders. Galen promotes ADASUVE in the United Kingdom as well as the United States. The company plans to continue expanding its portfolio with selected specialty products on an international basis. By combining innovation in product development with competitive pricing, Galen aims to work in partnership with healthcare professionals and patients to create real, long-term value.



Alexza Pharmaceuticals is focused on the research, development, and commercialization of novel, proprietary products for the acute treatment of central nervous system conditions. The Alexza products and development pipeline are based on the Staccato system, a hand-held inhaler designed to deliver a pure drug aerosol to the deep lung, providing rapid systemic delivery and therapeutic onset, in a simple, non-invasive manner.


ADASUVE [package insert]. Galen US Inc., Souderton PA; August 2017.


Hankin CS, Bronstone A, Koran LM. Agitation in the inpatient psychiatric setting: a review of clinical presentation, burden, and treatment. J Psychiatr Pract. 2011;17(3):170-185.


Lesem MD, Tran-Johnson TK, Riesenberg RA, et al. Rapid acute treatment of agitation in individuals with schizophrenia: multicentre, randomised, placebo-controlled study of inhaled loxapine. Br J Psychiatry. 2011;198(1):51-58.

4. Kwentus J, Riesenberg RA, Marandi M, et al. Rapid acute treatment of agitation in patients with bipolar I disorder: a multicenter, randomized, placebo-controlled clinical trial with inhaled loxapine. Bipolar Disord. 2012;14(1):31-40.


For Galen
Shannon Severino, 412-608-2393


For Galen
Shannon Severino, 412-608-2393