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FDA Approves Abuse-Deterrent Oxycodone Tablets (Roxybond) for Severe Pain Management

• The FDA has approved Roxybond (oxycodone hydrochloride) immediate-release 10 mg tablets, developed by Protega Pharmaceuticals, for managing severe pain where alternative treatments are inadequate. • Roxybond features SentryBond technology, making the tablets more difficult to manipulate for misuse, even with chemical extraction or physical alteration. • Clinical data suggests Roxybond's physicochemical properties reduce abuse via intranasal and intravenous routes, offering a multifaceted approach to opioid misuse reduction. • Pharmacists are advised to counsel patients, especially those with opioid use disorder risks, on Roxybond's role in a comprehensive pain management strategy.

Protega Pharmaceuticals' Roxybond (oxycodone hydrochloride) immediate-release (IR) CII 10 mg tablets have received FDA approval for the management of severe pain requiring opioid analgesics when alternative treatments are insufficient. The newly-approved Roxybond tablets are designed with abuse-deterrent properties.

SentryBond Technology

Roxybond incorporates SentryBond abuse-deterrent technology, combining inactive excipients with active pharmaceutical ingredients. This formulation makes the tablet more resistant to manipulation for abuse and misuse, even when subjected to chemical extraction or physical alteration. According to Protega, over 2000 in vitro tests demonstrated Roxybond's increased difficulty to manipulate compared to oxycodone IR.

Expert Commentary

"The FDA approval of Roxybond 10 mg with SentryBond 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 of Protega. He added, "When manipulated, our innovative technology renders the pill more difficult to misuse or abuse, such as being cut or crushed to snort or inject."

Abuse-Deterrent Formulations (ADFs)

ADFs have been in development for many years, with the first being marketed in 2010. Manipulation of opioids can lead to a "dose-dumping" effect, resulting in rapid and high serum levels of oxycodone and strong psychoactive effects. Creating opioid products that manage severe pain while preventing abuse and overdoses is a priority.
The SentryBond technology in Roxybond provides multiple protective layers that resist manipulation or transformation for injection. This technology has the potential for use in other medications, including hydromorphone, hydrocodone, and ADHD drugs.

Pharmacist's Role

Pharmacists should be prepared to counsel patients suffering from severe pain on potential treatment with Roxybond IR tablets, especially those with opioid use disorder or at risk of misusing their medications.

Addressing the Opioid Crisis

"The development of Roxybond with SentryBond is a step forward in fighting the national epidemic of prescription opioid overdose," stated Eric Kinzler, PhD, vice president of medical and regulatory affairs for Protega.
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Reference News

[1]
FDA Grants Approval to Oxycodone Hydrochloride Immediate-Release Tablets ... - Pharmacy Times
pharmacytimes.com · Oct 29, 2024

Protega Pharmaceuticals' Roxybond 10 mg tablets, approved by the FDA, use SentryBond technology to deter abuse through c...

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