Ensysce Biosciences said this week that its extended-release oxycodone prodrug won fast track status from the FDA.
The San Diego, Calif.-based company is developing the abuse-deterrent drug as a pain management therapy for people with moderate to severe chronic pain.
Ensysce’s prodrugs are only activated once they reach the small intestine, where enzymes set off a two-step activation process. Those activation enzymes aren’t found in a person’s blood or saliva, so there’s no chance for activation if the drug is injected, chewed or snorted, according to the company.
In a Phase I dose-escalation trial, Ensysce validated PF614’s extended-release pharmacokinetics and showed that the extended-release oxycodone product is safe.
“Ensysce is pleased the FDA recognizes that PF614 meets the Fast Track criteria and will contribute to deterring opioid abuse. We are focused on the rapid development of PF614 and our product pipeline designed to overcome abuse and overdose of prescription drugs,” CEO Lynn Kirkpatrick said in prepared remarks.
“Our prodrug approach, BIO-MD is well differentiated from abuse-deterrent formulations of existing opioid drugs that have been marketed for the past few years. While all abuse-deterrent formulations have been able to reduce some forms of abuse, they still contain substantial quantities of bioavailable opioids that can be extracted and abused by all routes of administration. Since PF614 is a unique 2-step prodrug that is completely inactive until it is metabolized in the small intestine after oral administration, we believe that BIO-MD and the combination MPAR overdose protection products are unique in the field.”