From the Wires
BHR Pharma Investigational Traumatic Brain Injury Treatment Receives European Medicines Agency Orphan Medicinal Product Designation
SyNAPSe® Trial Evaluating Intravenous Progesterone Formulation BHR-100 Aims to Bring First-Ever Approved TBI Treatment to Market
By: PR Newswire
Feb. 13, 2013 10:17 AM
HERNDON, Va., Feb. 13, 2013 /PRNewswire/ -- BHR Pharma, LLC announced today the European Medicines Agency (EMA), responsible for evaluating medicines developed for use in the European Union, granted an orphan medicinal product designation for treating moderate and severe traumatic brain injury (TBI) to its proprietary intravenous progesterone infusion agent, BHR-100. The agent currently is being evaluated as a neuroprotective treatment for severe traumatic brain injury (TBI) in the global, Phase III SyNAPSe® clinical trial.
BHR Pharma is sponsoring SyNAPSe with the intent to bring the first-ever approved TBI treatment to market. The trial currently has 154 participating sites, including U.S. Level 1 and 2 trauma centers, in 21 countries on four continents.
"Traumatic brain injury or TBI is a global problem that needs a global solution, and with providing an orphan drug designation for BHR-100 in Europe, the EMA acknowledges the importance of supporting the development of this potential treatment in TBI," said Roland Gerritsen van der Hoop, BHR Pharma Chief Medical Officer and Head of Global R&D. "BHR is committed to bringing this first-of-its-kind treatment to market with the hope of demonstrating progress in a condition with no approved therapies."
To qualify for orphan designation in Europe, a medicine must meet the following criteria:
In 2009, the U.S. Food and Drug Administration granted BHR-100 an Orphan Drug designation also for treating moderate and severe TBI and placed the drug on Fast Track status designed to accelerate its potential approval.
BHR initiated the SyNAPSe trial in June 2010 with a total enrollment target of 1,180 severe TBI patients. The trial is now more than 75 percent enrolled. Last month, the SyNAPSe trial's Independent Data and Safety Monitoring Board (DSMB) released its formal interim analysis, concluding no safety issues exist, there was no reason to stop the study for futility and the trial may continue towards its intended completion. Patient enrollment is set to complete in 2013.
About Traumatic Brain Injury (TBI)
About BHR Pharma
 Socin et al. JAMA273:22 (1995).
SOURCE BHR Pharma, LLC
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