Once the efficacy study is done — the trial that proves definitively that progesterone works as a treatment for moderate to severe TBI — and after it is FDA-approved, progesterone would be a cheap and readily available drug.
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This is a phase III efficacy trial meaning that this is THE trial to prove whether progesterone works for traumatic brain injury. And if it's positive, we believe that it should be able to be used as soon as the FDA gives approval--which should be relatively shortly after the trial. I will say there's--progesterone--the technology of progesterone for traumatic brain injury has actually been licensed by a company called BHR Pharma. That actually is a good thing because BHR Pharma is running a separate trial-- separate from ours--and their trial is more international. There are some subtle differences, They're just in severe traumatic brain injury. We're looking at moderate and severe, and our timing is different. But most importantly is that their formulation is a little bit different. They have developed a ready-to-use, stable formulation that would be ready to go to market as soon as the FDA says, yep, let's go. Ours is because we're academia--we're NIH-funded-- we weren't so concerned about trying to have something packaged and ready. We're just basically trying to decide--does the drug work? Does progesterone work or not? It would be a little bit more complicated to take what we use in the trial because we compound it right before we ship it out to the different sites. It would be a little more complicated, so it's good that there's a partner out there already thinking along these lines-- to get a drug ready to be available. It's very cheap. It's widely available. It comes from yams. The drug company--BHR Pharma-- actually has promised that they're going to keep the drug inexpensive. By the way, BHR Pharma already produces about 60% of the progesterone sold in the world today, so their parent company--called Besins Pharmaceuticals-- is the company that has been working in this space for many years in hormones and other things. They're a Belgium-based company, and they have immense experience and would be very-quickly able to ramp up and produce this at the level that would be needed.
Posted on BrainLine October 25, 2012. Reviewed July 25, 2018.
About the author: David Wright, MD, FACEP
David Wright, MD is a tenured associate professor in the Department of Emergency Medicine, Emory University, and the director of the division of Emergency Neurosciences.
Produced by Victoria Tilney McDonough, Ashley Gilleland, Justin Rhodes, and Erica Queen, BrainLine.
