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MorphaBond ER

Generic name: morphine sulfate
Treatment for: Pain

Inspirion Delivery Technologies Announces FDA Acceptance of MorphaBond ER (morphine sulfate extended-release) NDA

VALLEY COTTAGE, N.Y., Feb. 9, 2015 /PRNewswire/ -- 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and efficacy of MorphaBond ER, compiled from an extensive abuse-deterrent development program based upon the FDA's draft guidance, "Abuse-Deterrent Opioids – Evaluation and Labelling," published in January 2013 ("Guidance").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.

About MorphaBond ER

MorphaBond ER is an investigational opioid analgesic, utilizing IDT's patent-protected, proprietary technology.

MorphaBond ER is not approved for any indication in any market.

About Opioid Abuse

According to the Centers for Disease Control and Prevention, in 2012, there were 16,007 deaths which involved prescription opioid analgesics in the United States.1 From 1999 through 2012, the age-adjusted drug-poisoning death rate for drug-poisoning deaths involving opioid analgesics more than tripled.1 Drug overdose was the leading cause of injury death in 2012. Among people 25 to 64 years old, drug overdose caused more deaths than motor vehicle traffic crashes.2 In 2012, the National Survey on Drug Use and Health reported that more than 12 million individuals in the U.S. used prescription opioids for non-medical purposes in the previous year. Approximately 70 percent of these non-medical prescription opioid users obtained them from a friend or relative.3

About IDT Abuse-Deterrent Technologies

IDT has developed innovative and patent-protected abuse-deterrent technologies which extensive testing indicates could have the potential to offer new options to help physicians combat opioid diversion and abuse. The IDT technologies work without the addition of aversive agents or opioid antagonists and are covered by multiple U.S. and international patents and patent applications. MorphaBond ER (morphine sulfate extended-release tablets) is the first of a number of product candidates under development by IDT using this abuse deterrent formulation platform to advance to NDA submission based on the standards set forth by the FDA in the Guidance.

About Inspirion Delivery Technologies, LLC

Inspirion Delivery Technologies, founded in 2008, is a privately held specialty pharmaceutical company that is dedicated to advancing solutions in the field of prescription drug abuse deterrence through continued innovation. Recognizing the dire unmet public health need to combat the escalating epidemic of opioid abuse and addiction, IDT began pioneering the development of novel abuse-deterrent technologies. For more information, visit the Company's website at www.inspiriondt.com.

About Trygg Pharma Group

Trygg Pharma Group is a Norwegian-based 50/50 joint venture between the Norwegian industrial investment company Aker ASA and the New York based investment firm Lindsay Goldberg LLC. TPG focuses on drug development through its investments in IDT's abuse-deterrent development programs, as well as in the field of omega-3-based pharmaceuticals. www.tryggpharma.com

References

  1. NCHS. Multiple cause-of-death data, 1999–2012. CDC WONDER online database. http://wonder.cdc.gov/mcd.html. January 22, 2014. Accessed February 6, 2015.
  2. Centers for Disease Control and Prevention. Web-based Injury Statistics Query and Reporting System (WISQARS) [online]. http://www.cdc.gov/injury/wisqars/fatal.html. November 14, 2014. Accessed February 6, 2015.
  3. Substance Abuse and Mental Health Services Administration. Results from the 2012 National Survey on Drug Use and Health: Summary of National Findings. NSDUH Series H-46, HHS Publication No. (SMA) 13-4795. Rockville, MD: SAMHSA; 2013.

Source: Inspirion Delivery Technologies, LLC

Posted: February 2015

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