Protega Pharmaceuticals has announced that the FDA has granted approval for oxycodone hydrochloride (RoxyBond) as an alternative treatment for managing severe pain. The newly approved formulation is an immediate-release (IR) schedule II tablet specifically designed for patients whose pain requires opioid analgesics and for whom other treatments have been insufficient. The 10 mg dosage of RoxyBond is intended for patients needing effective pain management, indicating a targeted approach to addressing severe pain conditions.
A significant aspect of RoxyBond is its incorporation of SentryBond abuse-deterrent technology. This technology employs various chemical and physical methods to make the tablet more resistant to abuse and misuse, without the use of aversive agents.
According to Protega, the SentryBond formulation helps maintain the intended release profile of extended-release products while delaying the release of immediate-release medications. The tablet’s design makes it more challenging to manipulate through methods such as crushing or chemical extraction, effectively creating a barrier to abuse that is vital in the context of the ongoing opioid crisis.
Extensive testing has validated the abuse-deterrent features of RoxyBond, with over 2000 in vitro tests conducted. The results from these tests, coupled with findings from human abuse potential studies, indicate that RoxyBond has a significant capacity to resist manipulation.
Eric Kinzler, PhD, vice president of medical and regulatory affairs at Protega, emphasized the company’s commitment to combating prescription opioid abuse. The introduction of RoxyBond with SentryBond technology is seen as a crucial step in addressing the national epidemic of prescription opioid overdoses.
While the SentryBond technology is promising, the risks associated with opioid medications persist. Patients using oxycodone hydrochloride may still face the dangers of addiction and severe side effects if not properly monitored.
Potential life-threatening effects include respiratory depression, sedation, hypotension, coma, and even death, especially when combined with other depressants such as benzodiazepines or alcohol. As a result, healthcare providers must carefully assess each patient’s risk for opioid addiction before prescribing RoxyBond to ensure safe and effective pain management.
The 10 mg immediate-release tablets are expected to be available by the end of 2024, adding to the existing dosages of oxycodone hydrochloride. Currently, this medication is already accessible in 5 mg, 15 mg, and 30 mg doses.
In addition to RoxyBond, the potential for applying SentryBond technology to other medications, such as hydrocodone and ADHD treatments, has been suggested, although these applications have yet to receive FDA approval. The development of RoxyBond signifies a notable advancement in the pharmaceutical sector, aimed at balancing pain management with the imperative to mitigate the risks of opioid abuse.
