BHR Files IND Application For BHR-100

BHR Pharma (BHR) has filed an Investigational New Drug (IND) application with the 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 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.

Reportedly, the study is expected to randomise approximately 1,200 patients at 100 – 120 sites to receive a five-day 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.

The company has 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 company plans to request that the treatment be fast tracked during the regulatory approval process.

Tom MacAllister, president and CEO of BHR, said: “Traumatic brain injury is a terrible condition with high rates of mortality and disability, and currently there are no drugs approved for treating these patients.

“We’re excited about achieving the IND milestone and believe that the orphan status will help facilitate a development program with the potential to give these patients and their families hope for better quality of life.”