FDA Approves Roxybond 10mg for Severe Pain with Abuse-Deterrent Technology

• The FDA has approved Protega Pharmaceuticals' Roxybond 10mg for managing severe pain when alternative treatments are inadequate.
• Roxybond is the first FDA-approved immediate-release oxycodone formulation with abuse-deterrent technology designed to reduce misuse via intranasal and intravenous routes.
• The SentryBond technology in Roxybond makes the tablet more difficult to manipulate, potentially reducing abuse while providing pain relief.
• Roxybond's approval addresses the critical need for safer opioid pain management options amid the ongoing opioid crisis, with over 108,000 drug overdose deaths reported.

The U.S. Food and Drug Administration (FDA) has granted approval to Protega Pharmaceuticals' Roxybond (oxycodone hydrochloride) immediate-release 10 mg tablet, indicated for the management of severe pain that requires an opioid analgesic and for which alternative treatments are inadequate. Roxybond incorporates SentryBond technology, making it more difficult to manipulate for misuse, specifically via intranasal and intravenous routes.

Abuse-Deterrent Formulation

Roxybond 10 mg is the first and only FDA-approved, abuse-deterrent, immediate-release oxycodone formulation. According to Protega, over 2000 in vitro tests demonstrated that Roxybond is more difficult to manipulate compared to oxycodone IR, suggesting a reduced potential for abuse via intranasal and IV routes of administration. However, the company warns that abuse is still possible through intranasal, IV, and oral routes.

Paul Howe, chief commercial officer at Protega, stated that the approval fulfills an unmet need for an IR opioid with abuse-deterrent technology. He added that the technology renders the pill more difficult to misuse or abuse, such as being cut or crushed to snort or inject.

Clinical Considerations and Warnings

Protega advises that Roxybond should only be used in patients for whom alternative treatment options have not been tolerated or do not provide adequate analgesia. It should not be used for an extended period unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate. The drug carries a warning for life-threatening or fatal respiratory depression, particularly with dosage increases, and is contraindicated in patients with significant respiratory depression, acute or severe bronchial asthma in an unmonitored setting, hypercarbia, gastrointestinal obstruction, and hypersensitivity to oxycodone.

Addressing the Opioid Crisis

The approval comes amid a national opioid crisis. The American Medical Association estimates that 3% to 19% of people who take prescription pain medications develop an addiction. CDC data indicates that more than 108,000 drug overdose deaths occurred in the 12-month period ending in April 2022, with 75% of all drug overdoses in 2020 involving opioids. WebMD reports that around three million people in the United States either have opioid use disorder (OUD) or have dealt with it in the past.

Existing treatments for opioid use disorder include medications like buprenorphine, methadone, and non-opioid options like clonidine. Revia (naltrexone) can also be used to support detoxification and treat OUD chronically by blocking the body’s response to opioids and reducing cravings.

Future Directions

Eric Kinzler, PhD, VP, medical and regulatory affairs, Protega, emphasized that the development of Roxybond with SentryBond is a step forward in combating prescription opioid overdose. The company plans to responsibly launch Roxybond 10 mg and advance its technology platform for potential application in other commonly abused prescription medications. Roxybond was previously approved in 5 mg, 15 mg, and 30 mg tablets.