The FDA has granted Breakthrough Therapy Designation (BTD) for PF614-MPAR (Ensysce Biosciences), a next-generation opioid the company believes to be the first product with oral overdose protection in any drug class.
BTD is a rarely used designation designed to expedite the development and review of drugs that are intended to treat a serious condition where preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapies.
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