FDA Set To Review Investigational Abuse-Deterrent Opioid
The FDA is set to review an investigational abuse-deterrent opioid
Inspirion Delivery Technologies and Trygg Pharma Group announced that the FDA has accepted for filing the New Drug Application (NDA) for MorphaBond ER (morphine sulfate extended-release), an abuse-deterrent formulation for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
MorphaBond ER with the utilization of Inspirion Delivery Technologies' patent-protected, proprietary technology has been designed to be abuse-deterrent without the use of antagonists or aversive agents.
The NDA submission includes non-clinical and clinical data on the safety and efficacy of MorphaBond ER, compiled from an extensive abuse-deterrent development. The MorphaBond ER development program included multiple in vitro, pharmacokinetic, and human abuse liability, or drug "liking," studies.