FDA grants Fast Track designation to NeuroSTAT for treating traumatic brain injury

FDA grants Fast Track designation to NeuroSTAT for treating traumatic brain injury.

The US Food and Drug Administration, FDA has granted Fast Track designation to NeuroSTAT, for treatment of moderate to severe traumatic brain injury, TBI. This will facilitate its clinical development and path forward to market.

NeuroSTAT protects and stabilizes mitochondria and is in development for the treatment of moderate to severe traumatic brain injury. It focuses on secondary brain cell damage that occurs after head trauma. The candidate drug has previously been evaluated in a European clinical Phase II trial focused on safety, where analyses of brain cell injury biomarkers showed signals of clinical effect. In addition, in a clinically relevant experimental model, NeuroSTAT significantly reduced the volume of brain injury by 35%. NeuroSTAT has orphan drug designation in both Europe and the US.

Traumatic brain injury (TBI) is caused by an external force to the head resulting in immediate damage to nerve cells. The damage continues to worsen for several days after the acute trauma. The most common causes for TBI are trips and falls, traffic accidents and assault and battery 1). With more than 50 million new cases occurring each year, TBI is estimated to cost the global economy nearly 400 billion dollars annually in direct and indirect healthcare costs 2). A large number of patients suffer moderate to severe functional disabilities requiring intensive care and various forms of lifelong support.

NeuroSTAT's Food and Drug Administration Fast Track designation makes NeuroVive eligible, for example, for more frequent meetings and written communication with the FDA, continuous feedback on each section of its New Drug Application, NDA (for sale and marketing in the US), as well as the possibility to have its NDA reviewed within a shorter timeframe. Fast Track designated drugs address unmet medical needs in serious conditions, and the process is designed to facilitate accelerated drug development and, ultimately, to get new drugs to patients faster.

"The Fast Track designation and the recently approved IND (Investigational New Drug) are tremendous successes for our candidate drug NeuroSTAT, and a significant external validation of its quality and potential to address a tremendous unmet medical need. This will strengthen our position in the field and give us an advantage in partnering discussions concerning our planned Phase II efficacy study", said NeuroVive's CEO Erik Kinnman.

The Food and Drug Administration(FDA) continues to work with the research and clinical community to develop better-designed clinical studies so new medical products can be developed. And it continues to review and evaluate medical devices for safety and effectiveness.

More sensitive and objective ways to diagnose and detect mild TBI are needed. And timely diagnosis is important to prevent repetitive injury and to help develop new therapies.