FDA grants breakthrough therapy designation to opioid with ‘overdose protection’

The FDA has granted breakthrough therapy designation to PF614-MPAR, a “next-generation opioid” designed to limit oral overdose potential, according to a press release from its manufacturer.
The designation “highlights the advancement we have made with our approach to treating severe pain,” Ensyce Biosciences CEO Lynn Kirkpatrick, PhD, said in the release.
“[Breakthrough therapy designation (BTD)] facilitates our ability to expedite our programs through the approval processes in an efficient manner, with rolling review of both programs. We believe our goal of

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