Navigation Links
BHR Pharma Files Investigational New Drug Application, Receives Orphan Drug Designation, for Traumatic Brain Injury Treatment

HERNDON, Va., Dec. 8 /PRNewswire/ -- BHR Pharma, LLC (BHR) announced today that it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (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. The study will randomize approximately 1,200 patients at 100 - 120 sites to receive a five-day (120-hour) 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.

TBI is a non-degenerative, non-congenital insult to the brain from an external mechanical force, possibly leading to permanent or temporary impairments of cognitive, physical and psychosocial functions with an associated diminished or altered state of consciousness. An estimated 1.5 million Americans per year suffer a traumatic brain injury, resulting in 50,000 deaths, 235,000 hospitalizations and 80,000 cases of long-term disability.

The leading cause of death and disability in children and young adults worldwide, TBI is involved in nearly half of all trauma deaths. Traffic accidents account for 40-50 percent of the hospitalizations related to the condition.

BHR 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 FDA only designates orphan-drug status on novel drugs or biologics that treat a rare disease or condition affecting less than 200,000 Americans. The designation offers a number of incentives to the treatment developer. This includes a seven-year period of U.S. marketing exclusivity if the drug receives marketing authorization by the agency. Funding for clinical studies, study design assistance, waiver of FDA user fees and tax credits are additional potential incentives.

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

"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," said Tom MacAllister, BHR president and CEO. "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."

About BHR

Founded in January 2008, BHR Pharma, LLC ( is a pharmaceutical research and development (R&D) company located near Washington, DC. BHR is committed to bringing to market specialty treatments that employ non-oral delivery systems, with an emphasis on unmet and underserved medical needs.

A wholly owned subsidiary of Besins Healthcare SA (, which markets healthcare products in 93 countries, BHR manages all of Besins' global R&D activities. Those activities primarily leverage proprietary parenteral drug formulations, including the Enhanced Hydroalcoholic Gel (EHG(R)) technology pioneered and commercially launched by Besins in 1975.


Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Anemia and tropical diseases; Is pharmacogenomics ready for the clinic?
2. Mylan Commences Tender Offers and Consent Solicitations for Its 5.750% Senior Notes Due 2010 and 6.375% Senior Notes Due 2015 in Connection With Its Proposed Acquisition of Mercks Generic Pharmaceutical Business
3. Arena Pharmaceuticals to Present at the NewsMakers in the Biotech Industry Conference
4. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Zyloprim(R)
5. The Pharma & Life Sciences Best Practice Database: an Industry Resource for Successful Techniques and Performance Benchmarks for Reaching the Top
6. Schering-Plough/Merck Pharmaceuticals Announce FDA Filing Acceptance of New Drug Application for Loratadine/Montelukast Tablet
7. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Adipex-P(R)
8. National Pharmaceutical Council Announces New Strategic Focus, Search for New Leadership
9. AKELA Pharma Inc. announces positive results for the extension part of its Phase IIb Fentanyl TAIFUN(R) trial
10. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Coreg(R)
11. Innocoll Agrees the Sale of its CollaRx(R) GENTAMICIN SURGICAL IMPLANT and European Sales and Marketing Infrastructure to EUSA Pharma
Post Your Comments:
(Date:11/27/2015)... ... 27, 2015 , ... The men and women on this ... in the country. They have overseen financial turnarounds, shown commitment to their community ... industry as a whole through their advocacy and professional efforts. , Becker's Hospital ...
(Date:11/26/2015)... ... 2015 , ... Inevitably when people think Thanksgiving, they also think Holiday sales ... Black Friday and Cyber Monday massage chair sales to receive the best ... low to find the best massage chair deals, they can see all of the ...
(Date:11/26/2015)... (PRWEB) , ... November 26, 2015 , ... PRMA Plastic ... November 19, 2015, our surgeons performed their 6,000th free flap breast reconstruction surgery! , ... wake up every day excited to rebuild lives and it’s an honor to have ...
(Date:11/25/2015)... BROOK, Ill. (PRWEB) , ... November 25, 2015 ... ... larger and potentially more aggressive than those found on mammography, according to a ... MRI findings of additional cancers not seen on mammography may necessitate a change ...
(Date:11/25/2015)... ... 2015 , ... TyloHelo Inc , North America’s largest ... accessories help improve the bather experience in the sauna, and the accessories selected ... purist looking for simplicity in design to accessories that encourage a greater expression ...
Breaking Medicine News(10 mins):
(Date:11/26/2015)... Nederland, November 26, 2015 ... Een nieuwe aanpak combineert immunotherapie met Bremachlorin-photodynamische ... ) --> ...      (Photo: ) ... Universitair Medisch Centrum (LUMC) blijkt ...
(Date:11/26/2015)... , Nov. 26, 2015 Research and Markets ( ... Pacific Cardiac Pacemaker Market Outlook to 2019 - Rise in ... Demand " report to their offering. ... Boston scientific and others. ... including Medtronic, Biotronik, Boston scientific and ...
(Date:11/26/2015)... , Nov. 26, 2015 Research and ... of the "2016 Future Horizons and Growth ... Market: Supplier Shares, Country Segment Forecasts, Competitive Intelligence, ... --> --> ... of the Japanese therapeutic drug monitoring market, including ...
Breaking Medicine Technology: