Daiichi Sankyo to commercialize two products formulated with SentryBond abuse-deterrent technology

MorphaBond is an abuse-deterrent formulation of extended release morphine using physical and chemical barriers, without the use of aversive agents or opioid antagonists.

Under the terms of the agreement, which is pending Hart-Scott-Rodino clearance, Inspirion will receive an upfront payment, in addition to milestone payments and royalties. Daiichi Sankyo will lead the commercialization of the co-promotion with Inspirion for MorphaBond, and if approved, the second product.

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.

“Our goal is to become a leader in the pain therapeutic area and to be known as a company that is focused on the needs of patients and committed to being part of the solution to prescription drug abuse,” says Ken Keller, President, Administrative and Commercial at Daiichi Sankyo, Inc. “MorphaBond is a valuable addition to the growing pain franchise at Daiichi Sankyo and will offer healthcare providers with a new option as part of a comprehensive approach to treating pain while fighting against the potential for abuse.”

“The FDA approval, this collaboration, and the joint commercialization of MorphaBond with Daiichi Sankyo are major milestones for Inspirion,” says Stefan Aigner, MD, CEO of Inspirion.

“Daiichi Sankyo is a leader in the U.S. pharmaceutical market and has established a substantial presence in the opioid market. Inspirion is excited to be collaborating together on the launch of MorphaBond.”

"Opioids have been integral in the management of moderate to severe pain for decades. However, a national public health crisis of prescription opioid abuse has evolved in the U.S. The development of abuse-deterrent formulations of opioids in concert with other opioid risk mitigation methods is imperative,” said Joseph V. Pergolizzi Jr, co-founder and Chief Operating Officer of NEMA Research, a Clinical Research Organization, and President of Naples Anesthesia and Pain Associates of Naples, Florida.