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news.The US Food and Drug Administration (FDA) has accepted for filing the new drug application (NDA) for Inspirion Delivery Technologies' (IDT) investigational drug, MorphaBond ER, an extended-release (ER), abuse-deterrent formulation of morphine for the management of pain.
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The NDA requests FDA to approve MorphaBond ER to manage pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
MorphaBond ER is an opioid analgesic, using the company’s patent-protected, proprietary technology.
IDT CEO Stefan Aigner said: "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."
Trygg Pharma Group (TPG), the Norwegian based 50/50 joint venture between Aker and Lindsay Goldberg, is IDTs investment partner in a number of opioid development programs, including MorphaBond ER.
If approved by the FDA, the abuse-deterrent properties of MorphaBond ER are intended to present multiple barriers to abuse through widely used methods of physical and chemical manipulation, and also several routes of administration, including oral, injection, insufflation and inhalation.
The NDA submission is based on 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and efficacy of MorphaBond ER, compiled from an extensive abuse-deterrent development program based upon the FDA’s draft guidance, ‘Abuse-Deterrent Opioids – Evaluation and Labelling’, published in January 2013 (Guidance).
IDT is focused solely on the development of Abuse-Deterrent Formulations (ADFs) of opioid products.