BHR Pharma, LLC initiated SyNAPSe, a global, Phase 3, multi-center pivotal trial, in June 2010 to evaluate the effectiveness of BHR-100, a proprietary progesterone formulation, in treating severe TBI. Progesterone is a hormone primarily known for its role in pregnancy. Previous clinical trials have shown that progesterone has neuroprotective properties for both males and females Traumatic brain injury (TBI) is a major cause of death and disability worldwide. Among TBI victims the injuries result from automobile crashes, sports accidents, assaults and injuries sustained on the battlefield
Currently there are no approved medications to improve patient outcomes for traumatic brain injury, a major cause of death and disability worldwide.
More than a sex hormone, progesterone was shown in several clinical trials to have significant neuroprotective properties that can be instrumental in improving TBI outcomes.
The BHR Pharma SyNAPSe Study builds on the promising results achieved in previous clinical trials by further investigating the safety and efficacy of progesterone as a treatment for severe TBI patients.