Acute agitation is a serious and common complication of a variety of major psychiatric disorders, including dementia, schizophrenia and mania. In addition, it is one of the most detrimental factors in the continued stigmatization of mental illness. The current standard in its management is either oral or intramuscular administration of antipsychotics and/or benzodiazepines. The major disadvantage of these management techniques is relatively slow onset of drug action. There is thus a clear medical need for rapid, non-invasive techniques to treat acute agitation. The goal of this proposal is to develop a device that rapidly delivers agitation treatment via deep-lung inhalation. Our product is targeting a subgroup of agitated patients who are willing to cooperate with caregivers (according to several surveys, more that half of agitated patients want to be medicated and take medications willingly during emergency treatment). Our company has developed an aerosol generation technology that enables rapid and reproducible delivery of many FDA-approved drugs to the systemic circulation and brain through inhalation using a compact inhaler. In this Phase I grant, we will prove the feasibility of using this technology to deliver two anti-agitation drugs, one antipsychotic and one benzodiazepine. In a subsequent Phase II grant, we will optimize the inhaler for use by agitated patients, and will complete all inhalation toxicology studies necessary for filing an Investigational New Drug application (IND) with the FDA. Clinical development of the new treatment of acute agitation would then be funded by outside investors or through a partnership with a major pharmaceutical company. Eventual approval of our inhaled product will markedly expand treatment options in behavioral emergencies and will likely substantially improve quality of life of patients who experience acute agitation.
