FDA accepts NDA filing for Inspirion Delivery Technologies' investigational drug, MorphaBond ER

Feb 10 2015

Inspirion Delivery Technologies, LLC ("IDT"), a specialty pharmaceutical company focused solely on the development of Abuse-Deterrent Formulations (ADFs) of opioid products, together with its financial partner Trygg Pharma Group ("TPG"), announced that the U.S. Food & Drug Administration ("FDA") has accepted for filing the New Drug Application ("NDA") submitted on November 21, 2014 for its investigational drug, MorphaBond™ ER, an extended-release (ER), abuse-deterrent formulation of morphine. MorphaBond ER is an opioid analgesic, utilizing IDT's patent-protected, proprietary technology. This NDA requests FDA approval of MorphaBond ER 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. TPG, the Norwegian based 50/50 joint venture between Aker ASA and Lindsay Goldberg LLC, is IDTs investment partner in a number of opioid development programs, including MorphaBond ER.

If approved, the abuse-deterrent properties of MorphaBond ER are intended to present multiple barriers to abuse via widely used methods of physical and chemical manipulation, as well as various routes of administration, including oral, injection, insufflation and inhalation. The product has been designed to deliver these features without the use of antagonists or aversive agents while maintaining the safety and efficacy that patients and their physicians trust to achieve pain relief. The NDA submission includes non-clinical and clinical data on the safety and efficacy of MorphaBond ER, compiled from an extensive abuse-deterrent development program based upon the FDA's draft guidance, "Abuse-Deterrent Opioids – Evaluation and Labelling," published in January 2013 ("Guidance"). The MorphaBond ER development program encompassed multiple in vitro, pharmacokinetic, and human abuse liability, or drug "liking", studies. The safety and efficacy of MorphaBond ER, as well as the intended abuse deterrent properties, and all the supportive data submitted in the NDA are subject to FDA review.

"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 U.S. 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," said Stefan Aigner, MD, CEO of IDT. "We look forward to continuing to work closely with the FDA through the review process."

"Our team has done an outstanding job developing and advancing MorphaBond ER to NDA submission. We are very satisfied with the continuing success of IDT's development programs and are proud to be a part of such a worthy effort. IDT and TPG have begun the process of evaluating partners to commercialize MorphaBond ER, if approved, and other opioids under development using IDT's technology, in the highly attractive U.S. specialty pain market," added Aaron Kramer, CEO, TPG.