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BHR Pharma Files Investigational New Drug Application, Receives Orphan Drug Designation, for Traumatic Brain Injury Treatment
Date:12/8/2009

HERNDON, Va., Dec. 8 /PRNewswire/ -- BHR Pharma, LLC (BHR) announced today that it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for its proprietary BHR-100 intravenous progesterone infusion product.

In September of this year, the company made public plans to initiate a global, Phase 3, pivotal trial (www.synapse-trial.com) in early 2010 to evaluate the safety and effectiveness of BHR-100 as a neuroprotective agent for treating severe (Glasgow Coma Scale scores of 4-8) traumatic brain injury (TBI) patients. The study will randomize approximately 1,200 patients at 100 - 120 sites to receive a five-day (120-hour) continuous intravenous infusion of progesterone or placebo. The protocol will require that treatment begin within eight hours of injury. Patients will be followed for six months post-injury.

TBI is a non-degenerative, non-congenital insult to the brain 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. An estimated 1.5 million Americans per year suffer a traumatic brain injury, resulting in 50,000 deaths, 235,000 hospitalizations and 80,000 cases of long-term disability.

The leading cause of death and disability in children and young adults worldwide, TBI is involved in nearly half of all trauma deaths. Traffic accidents account for 40-50 percent of the hospitalizations related to the condition.

BHR also announced that its product had recently been granted orphan drug status by the FDA Office of Orphan Products Development for early intervention in the treatment of moderate-to-severe closed-head TBI. The FDA only designates orphan-drug status on novel drugs o
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SOURCE BHR Pharma, LLC
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