Abuse-Deterrent Opioid May Hit US Shelves Soon

Daiichi Sankyo recently announced plans to lead the commercialization of FDA-approved oxycodone hydrochloride (RoxyBond) tablets.

Oxycodone hydrochloride immediate-release tablets are availablie in 5-mg, 15-mg, and 30-mg formulations. They are indicated to treat severe pain that cannot be treated by an opioid alternative therapy.

The drug is the only immediate-release opioid with labeling that details its abuse-deterrent properties, according to the release.

“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,” said Ken Keller, president, Administrative and Commercial, Daiichi Sankyo, Inc. “This combination of abuse-deterrent properties and clinical value for medically appropriate patients makes RoxyBond a good strategic fit for our growing pain franchise.”

Oxycodone hydrochloride is an abuse-deterrent formulation of oxycodone that harnesses physical and chemical barriers, according to the release. The drug does not use aversive agents or opioid antagonists to deter abuse.

Specifically, the drug uses SentryBond abuse-deterrent technology and contains inactive ingredients that make the tablet more difficult to misuse than traditional opioids, Daiichi Sankyo reported. Additionally, these properties remain strong, even if exposed to physical manipulation or chemical extraction.

Findings from in vitro and clinical trials suggest that oxycodone hydrochloride has physicochemical properties that hinder drug misuse via injection and intranasal administration difficult. Although the drug may deter some individuals, like with any opioid, the potential for misuse and abuse is still possible.

Oxycodone hydrochloride comes with a boxed warning regarding addiction, misuse, and abuse potential; respiratory depression; accidental ingestion; neonatal opioid withdrawal syndrome; cytochrome P450 3A4 interaction; and risks linked to concomitant use with benzodiazepines and other central nervous system depressants, according to the release.

Since addiction, abuse, and misuse remain a worldwide concern, prescriptions for oxycodone hydrochloride—even at recommended doses—should only be received by patients who cannot tolerate or have provided an inadequate response to other treatment approaches.

The drug should only be prescribed by healthcare providers that understand the potential risks and benefits of opioid use for pain management, according to the release.

Daiichi Sankyo obtained the rights to commercialize oxycodone hydrochloride following FDA approval, as outlined in an agreement with Inspiron Delivery Services. The launch will also require sales participation by Inspiron, according to a press release.

“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,” said Inspirion’s CEO, Stefan Aigner, MD, CFA. “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.”