Traumatic Brain Injury
Traumatic Brain Injury (TBI) is an injury to the brain stemming from an external mechanical force, possibly leading to permanent or temporary impairments of cognitive, physical, and psychosocial functions with an associated diminished or altered state of consciousness.1
Understanding TBI
Traumatic brain injury is the leading cause of death and disability in children and young adults worldwide and is involved in nearly half of all trauma deaths. Approximately 1.5 million Americans suffer a traumatic brain injury per year, resulting in 50,000 deaths, 235,000 hospitalizations and 80,000 cases of long-term disability.2 The leading cause of TBI in the world is road traffic accidents, accounting for 40-50% of the hospitalizations for TBI.3 4
Treating TBI
To date there has been no pharmacological agent developed that has proved to be effective in improving the outcomes from TBI.5 Progesterone – though widely considered to be primarily a sex hormone important in pregnancy and female reproductive functions – in fact, exerts a variety of activities on the central nervous system of both men and women.6 BHR is developing BHR-100, an intravenous emulsion of progesterone, as an acute treatment for TBI. Progesterone has been shown to improve TBI outcomes in experimental animal models7 and to enhance survival and functional outcomes in human TBI patients.8
1 Dawodu et al., Traumatic Brain Injury: Definition, Epidemiology, Pathophysiology (2007).
2 Neurological Disorders: Public Health Challenges, p. 164 (World Health Organization 2006).
3 Id. at 168.
4 Id.
5 Wright et al., Annals of Emer. Med. 49: 391-402 (2007).
6 Stein, Brain Res. Rev. 57:386-97 (2007).
7 Id.
8 Wright et al, (2007) supra.; Xiao et al., Critical Care 12:R61 (2008).