• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

Drug Delivery Business

  • Clinical Trials
  • Research & Development
  • Drug-Device Combinations
  • FDA
  • Pharmaceuticals
  • Policy

Ensysce Biosciences wins fast track status for abuse-deterrent oxycodone

January 30, 2018 By Sarah Faulkner

Ensysce BiosciencesEnsysce 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.”

Want to stay on top of DDBN content? Sign up for our e-mail newsletter for a weekly dose of drug-device news.

Filed Under: Featured, Food & Drug Administration (FDA), Pain Management, Pharmaceuticals, Regulatory/Compliance, Wall Street Beat Tagged With: ensyscebiosciences

IN CASE YOU MISSED IT

  • Elixir Medical reports sustained durability with bioadaptor compared to Medtronic stent
  • Senseonics closes public offering, private placement with Abbott
  • Embecta eyes shift from insulin delivery to broader medical supplies focus
  • Medtronic earns expanded CE mark for Prevail paclitaxel-coated balloon
  • Sequel Med Tech to pair automated insulin delivery system with Abbott’s future dual glucose-ketone sensor

Primary Sidebar

“ddb
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in drug delivery.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Footer

Drug Delivery Business News Logo

MassDevice Medical NETWORK

MassDevice
DeviceTalks
Medical Tubing + Extrusion
Medical Design & Outsourcing
MedTech100 Index
Drug Discovery & Development
Pharmaceutical Processing World
Medical Design Sourcing
R&D World

DRUG DELIVERY BUSINESS NEWS

Subscribe to Drug Delivery’s E-Newsletter
Advertise with us
About
Contact us
Privacy
Listen to our Weekly Podcasts

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy | RSS