First Patient Enrolled in Trial for Promising New TBI Drug
BHR Pharma, LLC, announced the enrollment of the first patient in its drug trial for a promising new drug for treating severe traumatic brain injury (TBI). This study, known as the SyNAPSe study, is a Phase 3 trial that will evaluate the safety and effectiveness of BHR-100, an intravenous progesterone infusion product. The drug will act as a neuroprotective agent in its treatment of TBI.
Approximately 1,200 patients at more than 100 sites will be randomized for participation in the study. Each patient will receive a continuous five-day intravenous infusion of BHR-100 or a placebo. The treatment must begin within eight hours of injury. The patients will be followed for six months following the injury.
TBI is caused when an external force causes injury to the brain. The external force is usually from a fall, car accident or explosion. The injury can cause a host of temporary or permanent impairments to the cognitive, physical and psychosocial functions of an individual. TBI is the leading cause of death and disability in children and young adults, and nearly half of all deaths from trauma result from TBI. Forty to fifty percent of TBI hospitalizations result from traffic accidents. Each year, approximately 1.7 million Americans suffer a TBI, resulting in 275,000 hospitalizations, 80,000 cases of long-term disability and 52,000 deaths.
BHR’s president and CEO stated that BHR is proud to lead the important effort to help those suffering from TBI, which receives little attention even though it affects more people per year than breast cancer and HIV/AIDS combined.
Last December, BHR announced that its TBI drug had been granted orphan drug status by the FDA. The orphan drug designation was given for early intervention treatment of moderate-to-severe closed-head TBI.
BHR’s TBI drug received a Fast Track Development Program designation in March, which speeds up the approval of new drugs undergoing clinical trials. The fast track designation is often granted to drugs showing promise in the treatment of serious, life-threatening conditions for which there is no drug treatment or no drug that works as well.
The FDA notified BHA in June that it had concluded a special protocol review of the SyNAPSe trial. The FDA concluded that, so long as the SyNAPSe results meet specific statistical significance goals and other measures, BHR will be able to seek marketing approval of BHR-100.
Resource: “BHR Pharma Enrolls First Patient in Phase 3 SyNAPSe Traumatic Brain Injury Trial” 7/23/10