FDA grants breakthrough therapy designation to opioid with ‘overdose protection’
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Key takeaways:
- PF614-MAR helps prevent overdoses by “shutting down” active drug release if too much has been consumed, the manufacturer said.
- The drug combines an oxycodone-based pain medication with a protease inhibitor.
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 bringing the ‘next generation' of analgesics for severe pain to those in need is becoming a reality,” she said.
According to the release, PF614-MPAR mitigates the possibility of overdose, either accidental or intentional, by “‘shutting down’ opioid release if too much active drug is consumed.” The drug combines PF614, an oxycodone-based medication developed by Ensyce, with nafamostat, a protease inhibitor that works in the gut.
The breakthrough therapy designation streamlines the process of developing the evidence needed for FDA approval, the company said. It comes with all the features of a fast-track designation, as well as “intensive guidance” for an efficient drug development program, according to the release.
The company has also announced that Ensysce CCO Geoff Birkett will present a poster on the drug at the Annual NIH Helping to End Addiction Long-term (HEAL) Initiative Scientific Meeting, scheduled for Feb. 7-8, in Bethesda, Maryland. The post will be entitled “PF614-MPAR: A Novel Trypsin Activated Abuse Protected (TAAP) Extended-Release Oxycodone Prodrug with Overdose Protection.”
“The Ensysce team is pleased with the exceptional data we were able to generate for our MPAR platform and our lead agent, PF614-MPAR,” Birkett said in a press release. “The U.S. opioid crisis has not been impacted by a new approach to address abuse for over the last two decades. Ensysce intends to change that with what we believe are disruptive platforms, TAAP and MPAR. We also believe our safer medications will address the growing issue of patients’ lack of access to analgesics to treat severe pain, a situation caused by the opioid crisis.”
References:
Our Strategy. https://ensysce.com/our-strategy/. Accessed Jan. 26, 2024.
Ensysce Biosciences to Present Groundbreaking Oral Overdose Protection for Opioids at the 5th Annual NIH HEAL Meeting. https://ir.ensysce.com/news/press-releases/detail/140/ensysce-biosciences-to-present-groundbreaking-oral-overdose. Accessed Jan. 26, 2024.
Perspective
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Nancy E. Lane, MD
The FDA has assigned breakthrough therapy designation to PF614-MPAR, a next generation opioid. The excitement about this medication is that it is reported to be a major scientific innovation — the first product with oral overdose protection in any drug class.
Clearly, an opioid that provides pain relief and has less chance for overdose would be a giant step forward in the treatment of our patients with chronic or severe pain. However, what is not known is if this new opioid type of medication is addictive. Although overdose risk maybe be reduced, it seems like, with addiction, the overdose risk may not be insignificant. For our patients in chronic and or severe pain, we will watch for the results of the clinical trials.
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