Daiichi Sankyo collaborates with Inspirion Delivery Sciences to commercialise MorphaBond extended release tablets for severe pain management in the US

Daiichi Sankyo, Inc. and Inspirion Delivery Sciences LLC announced that the companies have entered into a strategic collaboration agreement in the U.S. to commercialize FDA-approved MorphaBond (morphine sulfate) extended-release tablets, CII. The agreement also provides Daiichi Sankyo, Inc. with the rights to commercialize a separate investigational Inspirion compound in the U.S., if approved by the FDA. Both MorphaBond and the second product feature SentryBond, a unique, patent-protected abuse-deterrent technology.

MorphaBond (morphine sulfate) extended-release tablets, CII is an abuse-deterrent opioid indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative options are inadequate. MorphaBond is an abuse-deterrent formulation of extended release 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. Relative to morphine sulfate extended-release tablets, these properties of MorphaBond increase 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. MorphaBond was developed in accordance with the FDA Guidance on Abuse-Deterrent Opioids.

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. Overall, data from the Category 1 thru Category 3 in vitro and in vivo studies suggest that MorphaBond has properties that are expected to reduce abuse or misuse via injection or insufflation; however, abuse by these routes is still possible.

Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, physicians should reserve MorphaBond for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. MorphaBond is not indicated as an as-needed (prn) analgesic.