New Hope for Severe Head Trauma Treatment
BHR Pharma has recently announced plans for a study to begin in early 201
0. The study will be a multi-clinic trial to test the power and effectiveness of BHR-100, an intravenous progesterone infusion product, as an outcome-enhancing treatment option for patients with severe traumatic brain injury.
Currently, there are no FDA approved medications for use in improving the outcome for those suffering with traumatic brain injuries. The BHR Pharma study, if successful, will lead to the production and dissemination of the BHR-100 progesterone product as a neuroprotective substance for treating traumatic brain injury.
The study will span over 100 clinics in the U.S., Europe, Israel, and elsewhere about the globe, and will treat over 1200 traumatic brain injury patients. BHR-100 will be administered for 5 days to randomly selected patients with “severe closed head trauma” type traumatic brain injuries. BHR-100, unlike previous progesterone infusions, has been tailored to meet all U.S. Food and Drug Administration requirements for approval for use in humans.
BHR Pharma is cooperating with the American Brain Injury Consortium (ABIC) and the European Brain Injury Consortium (EBIC) to locate trial clinics and to help with the final design of the study. BHR has hired PRA International as a Contract Research Organization to assist in conducting the massive trial.
