Traumatic Brain Injury (TBI) is a serious public health problem that affects more than 1.7 million Americans each year. It is the leading cause of death and disability in children and young adults worldwide and is responsible for more than 52,000 deaths, 275,000 hospitalizations, and 80,000 cases of long-term disability in the US alone.
Caused by a bump, blow or jolt to the head or a penetrating head injury, a TBI disrupts the normal function of the brain. The severity of a TBI may range from “mild” – a brief change in mental status or consciousness to “severe” – an extended period of unconsciousness or amnesia after the injury. Contrary to most media portrayals, the leading cause of TBI is not injuries sustained during war or football, but road traffic accidents.
Despite significant efforts over the past 20 years, there is still no approved treatment to reverse the damage caused by TBI. However, there is a growing body of research to suggest that the sex hormone progesterone may be a powerful neurosteroid that can protect against the effects of TBI.
Discovery of progesterone’s neuroprotective properties began with the observation of a gender difference in response to experimentally induced traumatic brain injury (TBI). After noting anecdotal reports that female rats recover better than male rats following TBI, researchers conducted studies which showed that the hormone might account for this discrepancy in outcomes.
And while progesterone initially may seem like an unusual choice as a neuroprotective therapeutic agent, there is abundant evidence suggesting that this is a normal role of this steroid hormone. In addition to its well-known effects on the reproductive system, progesterone is a potent neurosteroid. Progesterone receptors are abundant and widely distributed in the central nervous system. Moreover, unlike other sex steroids, progesterone is not only synthesized in the gonads and adrenal glands, but also produced by glial cells in the brain and by Schwann cells in the peripheral nervous system.
BHR Pharma, based in Herndon VA, has developed BHR-100, a novel intravenous formulation of progesterone for treating TBI. The company’s Phase III multi-center SyNAPSe clinical trial is currently underway and has enrolled 500 of the 1,180 patients suffering from severe TBI needed.
BHR Pharma, is also studying BHR-310 (intranasal progesterone powder) a ready-for-use, nasal spray TBI treatment. The compound is being developed so that it may be administered to wounded warriors at the site of injury, without the help of medically trained personnel. Studies of progesterone for TBI show that the earlier progesterone is given the better the chance to prevent further damage and improve recovery. A simple nasal spray device would therefore allow the progesterone to begin working before patients are admitted to a hospital.
The FDA has granted Orphan Drug designation to BHR-100 and the drug is on a Fast Track status designed to accelerate its potential approval. SRxA’s Word on Health will continue to follow these developments and bring you news as it breaks.