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Galen acquires inhaled treatment for agitation in schizophrenia, bipolar I disorder
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Galen US recently announced acquisition of U.S. commercial rights to Adasuve, an orally inhaled form of loxapine, from Alexza Pharmaceuticals for agitation associated with schizophrenia or bipolar I disorder.
Adasuve is FDA approved for acute treatment of agitation in schizophrenia or bipolar I disorder in adults.
“We are excited to add Adasuve to Galen’s comprehensive product portfolio as we continue to increase our U.S. footprint,” Andrew Shales, general manager at Galen US, said in a press release. “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.”
Due to recent FDA-approved labeling changes and the Risk Evaluation and Mitigation Strategy (REMS) program, Adasuve will be available to a wider range of patients across more settings, including psychiatric emergency services.
Galen plans to expand distribution for Adasuve to increase availability in EDs and psychiatric centers.
Adasuve may only be administered at a health care facility enrolled in REMS.
“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,” Scott L. Zeller, MD, of the University of California, Riverside, said in the release. “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 noninvasive manner has the potential to improve patients’ experiences, their cooperation with healthcare providers and outcomes.”
Disclosure: Healio.com/Psychiatry was unable to confirm relevant financial disclosures at the time of publication.