FDA Approves Protega's RoxyBond 10mg with Abuse-Deterrent Technology
Key Insights
The FDA has approved RoxyBond 10mg, an immediate-release oxycodone hydrochloride tablet with abuse-deterrent technology, for managing severe pain (search) where alternative treatments are inadequate.
RoxyBond utilizes SentryBond technology, making the tablet more difficult to manipulate for misuse via intranasal and intravenous routes, while maintaining its intended release profile.
Protega plans to launch RoxyBond 10mg soon, adding to the existing 5mg, 15mg, and 30mg tablets, providing clinicians with a broader range of options for safer pain (search) management.
Protega Pharmaceuticals (search) has received FDA approval for its RoxyBond (oxycodone hydrochloride) immediate-release 10 mg tablet, formulated with SentryBond abuse-deterrent technology. This approval marks a significant advancement in responsible pain (search) management, providing a new tool to combat opioid abuse while effectively treating severe pain.
The FDA's decision underscores the critical need for abuse-deterrent formulations in addressing the ongoing opioid crisis. RoxyBond 10 mg is designed to be more difficult to manipulate for misuse, particularly through intranasal and intravenous routes, offering a safer alternative for patients requiring opioid analgesics.
SentryBond Technology
RoxyBond's SentryBond technology combines inactive excipients with the active pharmaceutical ingredient, oxycodone hydrochloride, to create a tablet resistant to physical and chemical manipulation. This patented technology aims to maintain the intended release profile of the drug, delaying the release of immediate-release products and preventing rapid absorption that can lead to abuse.
According to Paul Howe, Chief Commercial Officer of Protega, this approval fulfills an unmet need for an immediate-release opioid with abuse-deterrent properties. The technology makes the pill more difficult to crush or cut for snorting or injection, reducing the potential for misuse.
Clinical Implications
The addition of RoxyBond 10 mg to the existing 5 mg, 15 mg, and 30 mg tablets offers clinicians greater flexibility in tailoring opioid therapy to individual patient needs. This range of doses can enhance pain (search) control, reduce the risk of side effects, and facilitate smoother transitions during dosing adjustments.
Eric Kinzler, Ph.D., VP Medical and Regulatory Affairs for Protega, emphasized the company's commitment to fighting prescription opioid overdose. Protega aims to work with healthcare professionals to reduce misuse and abuse through innovative technology platforms applicable to other commonly abused medications.
Abuse Potential and Safety Information
While RoxyBond is designed to deter abuse, it is important to note that abuse is still possible via intranasal, intravenous, and oral routes. Over 2000 in vitro tests demonstrated that RoxyBond tablets were more difficult to manipulate compared to oxycodone IR. Human abuse potential studies suggest reduced abuse via intranasal and intravenous routes.
RoxyBond carries a boxed warning regarding serious and life-threatening risks, including addiction, abuse, and misuse, as well as life-threatening respiratory depression. Concomitant use with benzodiazepines or other CNS depressants can result in profound sedation, coma, and death. The drug is contraindicated in patients with significant respiratory depression, acute asthma, gastrointestinal obstruction, or known hypersensitivity to oxycodone.
Healthcare providers are encouraged to complete a REMS-compliant education program and counsel patients on the serious risks, safe use, and importance of reading the Medication Guide with each prescription.