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).
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 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.
"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.
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
