Oxycodone Hydrochloride and RoxyBond: A New Approach in Pain Management

FDA Approves RoxyBond for Pain Management

Today, Protega Pharmaceuticals announced that the FDA granted approval for oxyhydrochloride (RoxyBond) as an alternative treatment for managing severe pain. The approval has been granted for the use of immediate-release (IR) schedule II tablet at a dose of 10 mg. This medication should only be allotted to those whose pain requires an opioid analgesic in situations where other treatments have been insufficient.

Innovative Abuse-Deterrent Formulation

A key feature of this oxycodone hydrochloride is its formulation with SentryBond abuse-deterrent technology. The abuse-deterrent qualities of oxycodone hydrochloride are achieved through different chemical and physical methods that make it harder to abuse, misuse, and/or manipulate the tablet. These characteristics were validated through over 2000 in vitro tests, demonstrating its capacity to resist manipulation.

Commitment to Reducing Abuse

“Protega is dedicated to our mission to block the path to abuse...” stated Eric Kinzler, PhD, vice president of medical and regulatory affairs at Protega. The success of SentryBond technology for deterring potential abuse could extend to other medications, although these have not yet received FDA approval.

Potential Risks and Side Effects

• Patients remain at risk for opioid addiction.
• May cause severe side effects if not used correctly, including life-threatening respiratory depression.
• Commonly reported adverse reactions include nausea, constipation, and dizziness.

At present, oxycodone hydrochloride is already available at doses of 5 mg, 15 mg, and 30 mg. The IR 10-mg tablets are expected to become available before the end of 2024.