FDA Approves Protega Pharmaceuticals’ Roxybond for Severe Pain Management

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The FDA has approved Protega Pharmaceuticals’ Roxybond for pain management that requires an opioid analgesic and for which alternative treatments are inadequate. According to the company, Roxybond is the first and only FDA-approved, abuse-deterrent, immediate-release (IR) 10 mg oxycodone formulation designed to reduce the potential for abuse via intranasal and intravenous (IV) routes. Additionally, the treatment implements SentryBond technology, which makes the tablet more difficult to manipulate for misuse or abuse.¹

"The FDA approval of Roxybond 10 mg with SentryBond is a significant milestone for Protega and fulfills an unmet need for an IR opioid with abuse-deterrent technology that may reduce misuse and abuse while providing pain relief to medically appropriate patients when used as indicated," said Paul Howe, chief commercial officer, Protega, in a press release. "When manipulated, our innovative technology renders the pill more difficult to misuse or abuse, such as being cut or crushed to snort or inject."

Prior to approval, Protega stated that over 2000 in vitro tests were conducted to determine whether Roxybond was difficult to manipulate compared with oxycodone IR. The data suggested that the physicochemical properties of Roxyband could lower the potential for abuse via the intranasal and IV routes of administration. Despite this, abuse is still possible by intranasal, IV, and oral routes. Roxybound was previously approved in 5 mg, 15 mg, and 30 mg tablets.

Protega warns that Roxybound should only be used in patients for whom alternative treatment options have not been tolerated or that have not provided adequate analgesia. Additionally, the treatment should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate. Life-threatening or fatal respiratory depression may occur, mainly due to a dosage increase. Roxybound is contraindicated in patients with significant respiratory depression, acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment or hypercarbia, gastrointestinal obstruction, and hypersensitivity to oxycodone.¹

According to statistics from the American Medical Association, an estimated 3% to 19% of people who take prescription pain medications develop an addiction. According to the CDC, more than 108,000 drug overdose deaths occurred in the 12-month period ending April 2022. In 2020, 75% of all drug overdoses were a result of opioids.²

According to WedMD, around three million people in the United States either have opioid use disorder (OUD) or reported that they have dealt with it in the past. Current medications used to prevent withdrawal symptoms include Buprenex, Butrans, Probuphine, Suboxone, Dolophine, Methadose, Lucemyra, and clonidine, which are non-opioid drugs. Additionally, Revia can support detoxification in special circumstances, but it’s more commonly used to treat OUD chronically by blocking the body’s response to opioids and reducing cravings.³

"The development of Roxybound with SentryBond is a step forward in fighting the national epidemic of prescription opioid overdose," said Eric Kinzler, PhD, VP, medical and regulatory affairs, Protega, in the press release. "Protega is dedicated to our mission to block the path to abuse and work with healthcare professionals across the continuum of care to reduce misuse and abuse. We look forward to responsibly launching Roxybond 10 mg and advancing our innovative technology platform for potential application in other commonly abused prescription medications."

References

1. Protega Pharmaceuticals Receives FDA Approval for ROXYBOND™ (oxycodone hydrochloride) Immediate-Release 10 mg Tablet with Abuse-Deterrent Technology for Management of Pain. PR Newswire. October 29, 2024. Accessed October 29, 2024. https://www.prnewswire.com/news-releases/protega-pharmaceuticals-receives-fda-approval-for-roxybond-oxycodone-hydrochloride-immediate-release-10-mg-tablet-with-abuse-deterrent-technology-for-management-of-pain-302289975.html

2. Opioid Use Disorder. APA. Accessed October 29, 2024. https://www.psychiatry.org/patients-families/opioid-use-disorder#:~:text=According%20to%20the%20American%20Medical,develop%20an%20addiction%20to%20them.&text=People%20misusing%20opioids%20may%20try,it%20is%20more%20easily%20available.

3. Painkillers and Opioid Use Disorder. WebMD. Accessed October 29, 2024. https://www.webmd.com/mental-health/addiction/painkillers-and-addiction-narcotic-abuse