Development of a Precision Olfactory Delivery (POD®)-Olanzapine Drug-Device Product for Agitation
General Material Designation
[Article]
First Statement of Responsibility
Satterly, K H; Gajera, B; Davies, G J; Lin, H; Muppaneni, S; Wright, J; To, K; Shrewsbury, S B; Hoekman, J
SUMMARY OR ABSTRACT
Text of Note
Introduction: Agitation is a cluster of behaviors observed in multiple psychiatric diseases, which can increase the likelihood of violent behavior. Atypical antipsychotics, including oral and intramuscular (IM) olanzapine (OLZ), have been approved for chronic and acute agitation treatment, respectively, for schizophrenia and bipolar I disorder in the U.S. for over 20 years. During acute agitation episodes, IM OLZ is preferred over oral treatments due to a shorter Tmax. However, IM OLZ is invasive, predominantly administered in a hospital setting, and may require restraint if the patient is uncooperative, potentially reducing trust between patient and medical personnel and increasing the likelihood of injuries. When possible, non-injectable routes of administration are preferred during agitation events; however, slower-onset oral products often require labor-intensive observation of the medicated patient until adequate symptom resolution.
SET
Date of Publication
2019
Title
Western Journal of Emergency Medicine: Integrating Emergency Care with Population Health
Volume Number
20/2
PERSONAL NAME - PRIMARY RESPONSIBILITY
Entry Element
Satterly, K H; Gajera, B; Davies, G J; Lin, H; Muppaneni, S; Wright, J; To, K; Shrewsbury, S B; Hoekman, J