Inspirion Delivery Technologies LLC announced that the FDA has approved MorphaBondT (morphine sulfate) extended-release tablets, for oral use, CII. MorphaBond is an abuse-deterrent formulation of ER-morphine using physical and chemical barriers, without the use of aversive agents or opioid antagonists.
MorphaBond is formulated with inactive ingredients that make the tablet more difficult to adulterate for misuse and abuse while maintaining extended-release characteristics even if the tablet is subjected to physical manipulation, and/or chemical extraction. MorphaBond has been tested in vitro using methods of manipulation that drug abusers commonly use for preparation of extended-release opioids for administration by various routes, including oral consumption, intranasal insufflation, injection, and smoking. The laboratory test data demonstrated that, relative to morphine sulfate extended-release tablets, MorphaBond has increased resistance to cutting, crushing, or breaking using a variety of tools. When subjected to a liquid environment the manipulated MorphaBond formulation forms a viscous material that resists passage through a needle. An in vivo clinical abuse potential study was also conducted.
“The data from the clinical abuse potential study indicate that MorphaBond has properties that are expected to reduce misuse and abuse via the intranasal route of administration as the extended-release characteristics were largely maintained even after extensive manipulation of the formulation,” said Lynn R. Webster, MD, Principal Investigator, PRA Health Sciences, Salt Lake City, UT.
“Overall, the results indicate that MorphaBond has properties that are expected to reduce abuse or misuse via injection or insufflation; however, abuse by these routes is still possible,” continued Dr. Webster.
“Opioids have been the cornerstone of pain management for many years, however there is a national public health crisis of prescription opioid abuse in the U.S., which is why the development of abuse-deterrent formulations of opioids is an imperative for medicine,” said Joseph V. Pergolizzi Jr, MD, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD and Department of Pharmacology, Temple University School of Medicine, Philadelphia, PA.
Dr. Pergolizzi went on to say, “Morphine is abused and the development of MorphaBond will offer clinicians another valuable tool as part of a comprehensive approach in the fight against the potential for abuse.”
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 and that nearly 70 percent of these non-medical users reported that they obtained them from a friend or family member. According to the Centers for Disease Control and Prevention, from 1999 to 2010, the number of fatal overdoses involving prescription opioids increased four-fold, with 16,300 opioid-related deaths reported in 2010 alone. Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed MorphaBond and in those who obtain it illegally.
MorphaBond is administered orally every 12 hours and will be available in 15, 30, 60 and 100 mg tablets. MorphaBond should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain. Prescribers should review the full prescribing information, which contains important safety and dosing information, prior to prescribing MorphaBond.