Pharmos Corporation announced the Food and Drug Administration has granted fast track designation for dexanabinol for treatment of severe traumatic brain injury (TBI). In its designation, the FDA acknowledges TBI as a serious, often life-threatening condition for which no approved therapies exist, and the potential of dexanabinol in preventing secondary brain damage due to its neuroprotective effect. The most significant benefit to Pharmos is the expedited review of the New Drug Application for the compound, currently in advanced Phase III clinical testing.
"Fast track designation from the FDA for dexanabinol is an important confirmation of the serious unmet medical needs of TBI and of the promise dexanabinol holds toward filling those needs," said Gad Riesenfeld, President & COO. "As we near completion of the pivotal trial of dexanabinol, we look forward to utilizing the means provided under fast track to shorten dexanabinol's time to market, in particular the accelerated regulatory review. Pharmos will continue to work closely with the FDA to ensure that its R&D efforts are supportive of regulatory requirements."
The FDA Fast Track programs, codified under the FDA Modernization Act of 1997, are designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions, and that demonstrate the potential to address unmet medical needs. The programs emphasize the critical nature of close early communication between the FDA and sponsor to improve the efficiency of product development.