The FDA has accepted for review a New Drug Application for Inspirion Delivery Technologies' investigational opioid analgesic, MorphaBond ER, an abuse-deterrent formulation of extended-release morphine.
The FDA has accepted for review a New Drug Application (NDA) for Inspirion Delivery Technologies’ investigational opioid analgesic, MorphaBond ER, an abuse-deterrent formulation of extended-release morphine.
The NDA, which is supported by nonclinical and clinical data on the safety and efficacy of MorphaBond ER, requests the drug’s approval 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 was designed to resist physical or chemical manipulation and prevent abuse via oral administration, injection, insufflation, or inhalation. The opioid’s abuse-deterrent properties were implemented without the use of antagonists or aversive agents.
“We believe that MorphaBond ER, if approved by the FDA, will represent a major innovation in the field of prescription drug abuse deterrence and could be the first abuse-deterrent extended-release morphine product without an antagonist to be marketed in the US,” said Inspirion Delivery Technologies CEO Stefan Aigner, MD, in a press release. “MorphaBond ER is designed to try to help address the costly societal problem of opioid abuse without compromising safety and efficacy for patients and prescribers. Our market research suggests that physicians are very interested in options to help them combat the problem of opioid diversion and abuse.”
If approved, MorphaBond ER would become the latest abuse-deterrent opioid to receive the FDA’s nod, following Purdue Pharma’s Hysingla ER, which was launched in the United States in January 2015, and a new formulation of Zogenix’s Zohydro ER.