Extended-Release Oxycodone Prodrug Gets Fast-Tracked

An extended-release oxycodone prodrug, PF614 (Ensysce Biosciences), has been granted Fast Track designation by the Food and Drug Administration (FDA) as an around-the-clock analgesic for moderate to severe chronic pain for an extended period of time. 

PF614 is designed with a 2-step enzyme activation process intended to provide abuse deterrent properties and to limit its use to oral administration. The Company’s prodrugs differ from current opioid technologies in that they do not require a complex formulation to provide parenteral and nasal abuse-deterrence. Moreover, the 2-step approach makes the drug completely inactive until it is metabolized in the small intestine. 

A Phase 1 trial of PF614 compared the treatment to OxyContin in healthy subjects and found that it demonstrated safety and the extended-release characteristics of the prodrug delivery. 

“Our prodrug approach, BIO-MD is well differentiated from abuse-deterrent formulations of existing opioid drugs,” said Dr. Lynn Kirkpatrick, CEO, Ensysce Biosciences. “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.”

For more information visit Ensyces.com.