Daiichi Sankyo, Inc. and Inspirion Delivery Sciences LLC (Inspirion) have entered into a strategic collaboration agreement in the US 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 US, if approved by the US Food and Drug Administration (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.

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 US 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, MD, co-founder and chief operating officer of NEMA Research, a Clinical Research Organization, and President of Naples Anesthesia and Pain Associates of Naples, Florida.

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.

MorphaBond should be prescribed only by healthcare professionals who are knowledgeable in the use of opioids for the management of chronic pain.

The SentryBond technology platform combines inactive excipients with active pharmaceutical ingredients in a tablet that is specifically designed to frustrate abuse via various methods of manipulation and routes of administration. When subjected to physical manipulation and/or attempts at chemical extraction, SentryBond is designed to maintain the intended release profile of extended-release products and to delay the release of immediate release products. Inspirion's technology imparts its abuse-deterrent characteristics via physical and chemical methods, without the use of antagonist or aversive agents. SentryBond technology is covered by an issued US patent, with multiple US and global patent applications pending.