Navigation Links
BHR Pharma Files Investigational New Drug Application, Receives Orphan Drug Designation, for Traumatic Brain Injury Treatment
Date:12/8/2009

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 (www.synapse-trial.com) 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 o
'/>"/>

SOURCE BHR Pharma, LLC
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2

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:
*Name:
*Comment:
*Email:
(Date:12/19/2014)... drug users who also use cocaine and amphetamines have ... users, a new study finds. "We know that ... attempt and completed suicide," Didier Jutras-Aswad, a psychiatry professor ... news release. "However, there are many different profiles of ... users were actually more likely to attempt suicide." ...
(Date:12/19/2014)... Dec. 19, 2014 (HealthDay News) -- The cost of ... well-being, a new study finds. Researchers examined data ... been diagnosed with colorectal or lung cancer. Of those ... cancer-free, and more than 100 had advanced cancer. ... to pay their medical bills, which was linked with ...
(Date:12/19/2014)... NC (PRWEB) December 19, 2014 Surviving Mesothelioma ... and EPA information indicates that these pipes can leach asbestos ... go to the full story on the Surviving Mesothelioma ... the erosion of natural asbestos deposits, decaying water mains made ... drinking water. , To protect consumers from mesothelioma ...
(Date:12/19/2014)... Dennis Thompson HealthDay ... -- Ebola,s entrance into the United States -- along ... mumps outbreak -- have highlighted cracks in the nation,s ... new health policy report released Thursday. Half of ... respond to infectious disease outbreaks. That was the main ...
(Date:12/19/2014)... B. E. Smith, the only full-service leadership ... retained to lead a national chief financial officer ... The top executive search firm in the healthcare industry, ... healthcare executives into organizations. , Johnson Memorial Hospital ... to the residents of Johnson County and the surrounding ...
Breaking Medicine News(10 mins):Health News:Cocaine, Amphetamines May Up Injection Drug Users' Suicide Risk 2Health News:Cancer Treatment Costs Weigh Heavily on Patients, Study Finds 2Health News:Surviving Mesothelioma Warns of Potential Mesothelioma Risk from Cement Water Pipes 2Health News:Most States Not Ready to Handle Infectious Disease Outbreaks: Report 2Health News:Most States Not Ready to Handle Infectious Disease Outbreaks: Report 3Health News:Most States Not Ready to Handle Infectious Disease Outbreaks: Report 4Health News:Johnson Memorial Hospital Retains B. E. Smith to Recruit New Chief Financial Officer 2Health News:Johnson Memorial Hospital Retains B. E. Smith to Recruit New Chief Financial Officer 3
... benefits which could run parallel to that of penicillin ... of Medicine at Harvard Medical School. ,Professor ... levels in unrefined cocoa has the potential to combat ... world viz. stroke, heart ailments, cancer and diabetes. He ...
... German scientists have found that the scent of ... The scientists at the University of Lubeck, ... programmed bursts of rose odors, while they were memorizing cards ... sent off to sleep with electrodes connected to their heads. ...
... Hopkins emergency medicine specialists have developed a tool ... potential to overwhelm services//. ,The Electronic Mass ... calculates the impact of such crises as a ... accounting for such elements as numbers of victims, ...
... including those with a family history of the disease, should ... to prevent the disease. ,This is the first ... taking medicines to prevent colorectal cancer. After reviewing the latest ... potential harms of taking more than 300 mg per day ...
... who devote more time to physical activity have a ... next 15 years, according to new research// . ... physical activity is actually causally related to hypertension,” said ... an epidemiologist at the University of Minnesota in Minneapolis, ...
... conducted on mice shows that more copper in everyday ... was conducted by scientists at the University of Louisville ... ,Their studies show that giving copper supplements ... by preventing heart enlargement. The study will be published ...
Cached Medicine News:Health News:Scent of a Rose may Give More Than Pleasure 2Health News:Aspirin Or NSAIDs Will not Prevent Colorectal Cancer 2Health News:Physical Activity Reduces Hypertension Risk in Young Adults 2
(Date:12/19/2014)... , Dec. 18, 2014 Somewhere between dropping ... health was forgotten. But Audicus , a next-generation ... better this new year. Hearing loss is ... aging population, though it is often unaddressed. Forty-eight million ... has a hearing aid, mainly due to price. Hearing ...
(Date:12/19/2014)... 18, 2014  Sage Analytics ( www.sageanalytics.com ), ... for the testing of marijuana potency and moisture ... Luminary™ Profiler, the industry,s first product suite capable ... cost-effective, portable unit. Designed from the ... the cannabis industry, the Luminary™ Profiler utilizes specially ...
(Date:12/19/2014)... Dec. 18, 2014 Capnia, Inc. (NASDAQ: ... of medical diagnostics based on its proprietary Sensalyze™ ... today announced financial results for the third quarter ... "Following the completion of our initial public ... maximize the recently initiated CoSense® commercial launch," said ...
Breaking Medicine Technology:Audicus Will Help People Resolve to Hear Better in 2015 2Sage Analytics Develops Breakthrough System for Potency Testing of Cannabis Products 2Capnia Reports Third Quarter 2014 Financial Results 2Capnia Reports Third Quarter 2014 Financial Results 3Capnia Reports Third Quarter 2014 Financial Results 4Capnia Reports Third Quarter 2014 Financial Results 5Capnia Reports Third Quarter 2014 Financial Results 6Capnia Reports Third Quarter 2014 Financial Results 7Capnia Reports Third Quarter 2014 Financial Results 8
... Jan. 6, 2011 /PRNewswire-Asia-FirstCall/ -- Nutrastar International Inc. (OTC ... "Company"), a leading producer and supplier of premium branded ... the Company will be participating in the upcoming Cowen ... the Westin New York at Times Square (270 West ...
... 2011 Viveve, Inc. , a development stage ... the European CE (Conformite Europeenne) mark for the use ... laxity of the vaginal introitus (opening), after childbirth, to ... ) "The CE mark is a key ...
Cached Medicine Technology:Nutrastar to Present at the Cowen and Company 9th Annual Consumer Conference in NYC 2Nutrastar to Present at the Cowen and Company 9th Annual Consumer Conference in NYC 3Viveve Obtains CE Mark for Gynecologic Treatment of Vaginal Laxity 2
... Anterior Cervical Plate System provides ... The innovative design of our ... screw back-out. The implant easily ... reliable instrumentationincluding innovations like our ...
... TrinicaTM anterior cervical plate system features ... preferences and patient needs. Trinica system gives ... to each patient's unique anatomy. Flexibility is ... system-from plate design and the innovative Secure-TwistTM ...
... intended for supportive stabilization of the ... The device utilizes bi-cortical fixation for ... enhanced through dynamic screw holes and ... level interbody fusion. Anterior cervical corpectomy. ...
... The SC-Acufix anterior cervical plate system ... a patented, integrated swivel, which provides for ... and prevents bone screw disengagement or backout. ... a secondary locking screw. Simply implant your ...
Medicine Products: