Progesterone Treatment for TBIs in Final Trial Before USDA Approval

Car accidents, falls, and even sports-related accidents are some of the causes of 1.7 million traumatic brain injuries (“TBIs”) experienced by Americans every year.

TBIs have caused 52,000 deaths and cost more than $60 billion, according to the U.S. Centers for Disease Control and Prevention.

 And for those with a moderate or severe brain injury, there's little help.

BHR Pharma is currently conducting Phase III trial of a study with support from the American Brain Injury Consortium and the European Brain Injury Consortium which tests the hypothesis that the hormone progesterone can reduce the number of TBI related deaths or severe disability. 

This study that began in 2010 has doctors in 21 countries comparing severely brain-injured patients who receive an intravenous progesterone infusion to those who receive a placebo infusion. The study is designed to test the hypothesis that the hormone progesterone can reduce mortality and disability if administered right after a TBI.  Patients must begin the infusion within four hours of the injury, with outcomes assessed after six months.

The Phase III trial is expected to end this summer after enrolling 1,180 patients.  Results should be available in 2014.

Phase III is the last round of testing a treatment must go through before approval can be requested from the U.S. Food and Drug Administration.  That approval could come as early as the end of 2014, said Neta Nelson, global project director of the study and vice president of project management.

Small amounts of progesterone are found in the brains of both women and men, suggesting that it has neuroprotective as well as reproductive functions.

Experts believe progesterone appears to affect multiple physiologic processes that follow an acute injury.  It reduces the cerebral swelling that leads to brain cells dying off.  Progesterone also may blunt cellular damage from free radicals and promote myelin production in damaged nerve cells.