The treatment of acute agitation associated with psychosis or mania: investigational drugs in early clinical development, clinical context and potential place in therapy.

Acute agitation in patients with schizophrenia or bipolar disorder may require pharmacologic management before it progresses to aggressive behavior. Ideal medication characteristics for this indication include rapid onset, minimal side effects, and non-invasive administration techniques.Areas Covered: This review summarizes investigational agents in early clinical development for the management of acute agitation in patients with psychosis or mania; it also assesses where these agents may fit with current therapies to provide a clinical perspective. The authors conducted a broad search of clinicaltrials.gov to identify investigational agents for agitation or aggression in patients with schizophrenia or bipolar disorder. Results from the clinicaltrials.gov search were used to guide further literature searches in PubMed and Embase. Two medications met the search criteria: dexmedetomidine film (BXCL501) and intranasal olanzapine (INP105). These agents are undergoing or have recently completed early phase clinical trials assessing safety and pharmacokinetics.Expert Opinion: Olanzapine is a well-known molecular entity in the psychiatric armamentarium but dexmedetomidine would be a new and unfamiliar agent for mental health providers. Nonetheless, although it is too early to make definitive statements about tolerability and efficacy, their unique administration mechanisms suggest that dexmedetomidine film and intranasal olanzapine may become valuable options for the rapid management of acute agitation in patients who are willing to cooperate with medication therapy.