Daiichi Sankyo and Inspirion Delivery Sciences announced Daiichi Sankyo will lead the U.S. commercialization of FDA-approved RoxyBond (oxycodone hydrochloride) immediate-release tablets, for oral use, CII with Inspirion providing additional salesforce as part of Inspirion's co-promotion rights under the License Agreement. RoxyBond is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. RoxyBond is the first and only immediate-release opioid analgesic with approved labeling describing its abuse-deterrent properties, consistent with the FDA's 2015 Guidance for Industry.
"Data show that most people who abuse prescription opioids start with immediate-release formulations. Upon launch of RoxyBond, we'll be able to offer healthcare providers a valuable option that helps deter the potential for misuse and abuse while providing their patients relief from pain," Ken Keller, President, Administrative and Commercial, Daiichi Sankyo said. "This combination of abuse-deterrent properties and clinical value for medically appropriate patients makes RoxyBond a good strategic fit for our growing pain franchise."
RoxyBond is an abuse-deterrent formulation of immediate-release oxycodone that uses physical and chemical barriers, without incorporating aversive agents or opioid antagonists. RoxyBond, which features SentryBond, a unique patent-protected abuse-deterrent technology, is formulated with inactive ingredients that make the tablet more difficult to manipulate for misuse and abuse, even if subjected to physical manipulation and/or chemical extraction.
Data from in vitro and clinical studies suggest that RoxyBond has physicochemical properties that are expected to make abuse via injection difficult and reduce abuse by the intranasal route of administration. However, abuse by the intranasal, oral and intravenous routes is still possible.
Daiichi Sankyo secured the rights to commercialize RoxyBond following FDA approval as part of a License Agreement the company entered into with Inspirion in 2016 for MorphaBond ER (morphine sulfate) extended-release tablets, for oral use, CII and a separate investigational Inspirion compound in the U.S., such compound being RoxyBond. Under the terms of the agreement, Inspirion will receive an additional license fee payment and is also eligible for potential sales based milestones as well as royalties on net sales.
"We are excited to bring RoxyBond to market as the first immediate-release abuse-deterrent opioid, in addition to MorphaBond ER -- both products feature our SentryBond technology," Inspirion's CEO, Stefan Aigner, MD, CFA said. "We look forward to launching RoxyBond with Daiichi Sankyo, a strong partner with an established market presence and commitment to responsible marketing of prescription medications."
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, use of RoxyBond should be reserved for patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products) have not been tolerated or are not expected to be tolerated, and have not provided adequate analgesia or are not expected to provide adequate analgesia.