FDA to Review NDA for Investigational Abuse-Deterrent Opioid
Inspirion Delivery Technologies and Trygg Pharma Group announced that the Food and Drug Administration (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.