The European Medicines Agency (EMA) has reportedly granted an orphan medicinal product designation for treating moderate and severe traumatic brain injury (TBI) to BHR Pharma, LLC’s proprietary intravenous progesterone infusion agent, BHR-100. According to a recent news release, the agent’s promise as a neuroprotective treatment for severe TBI is currently being evaluated in the global Phase II SyNAPSe clinical trial. BHR Pharma reports that it is also sponsoring SyNAPSe with the intent to bring what it calls, “the first-ever approved treatment to the market.”
The company notes that the trial currently encompasses 154 participating sites, including US Level 1 and 2 centers in 21 countries on four continents. A recent company news release notes that in order to qualify for orphan designation in Europe, a medicine must be intended for the treatment, prevention, or diagnosis of a disease that is life threatening or chronically debilitating. Additional requirements dictate that the prevalence of the disease in the EU must also be more than 5 out of every 10,000 people and the new medicine is of significant potential benefit to those affected by the disease.
Roland Gerritsen van der Hoop, BHR Pharma, chief medical officer, head of global R&D, classifies traumatic TBI as a global problem requiring 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,” Gerritsen van der Hoop says.
For more information about the SyNAPSe trial, click here.
Source: BHR Pharma LLC