NFL Biosciences receives positive feedback from the FDA
The biopharmaceutical company explains that this process, initiated in December 2023, will enable it to formalize the NFL-301 development program under the best possible conditions.
The company's ambition is to develop the first oral botanical drug based on extracts of kudzu, a plant native to Asia, for the treatment of excessive alcohol consumption.
As part of its pre-IND application, the FDA recognized the interest of the new indication, namely the treatment of binge drinking.
In order to qualify as a botanical drug candidate, the Kudzu extract from which NFL-301 is developed will have to comply with the guidelines for botanical drug candidate development
. The selected formulation will have to be submitted to the FDA prior to the clinical trial application.
On the Paris Bourse, NFL shares gained over 2% in the wake of this announcement.
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