Protega Pharmaceuticals LLC Announces Commercialization of Oxycodone Hydrochloride Tablets CII in the US
Protega Pharmaceuticals LLC recently announced the commercial launch of RoxyBond (oxycodone) immediate-release (IR) tablets in the US. RoxyBond was approved by the US FDA as an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, use of RoxyBond should be reserved for patients for whom alternative treatment options (eg, non-opioid analgesics or opioid combination products) have not been tolerated or are not expected to be tolerated, and have not provided adequate analgesia or are not expected to provide adequate analgesia. The FDA is encouraging the development of prescription opioids with abuse-deterrent formulations (ADFs) to help combat the opioid crisis. The agency recognizes that abuse-deterrent opioids are not abuse or addiction-proof but are a step toward products that may help reduce abuse. RoxyBond is the first and only immediate-release opioid analgesic with approved labeling describing its abuse-deterrent properties, consistent with the FDA’s current Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling. RoxyBond is approved in three dosage strengths: 5, 15, and 30 mg.
“Data show that many people abuse immediate-release prescription opioids. With the launch of RoxyBond, we are now able to offer healthcare providers a treatment option that is expected to reduce abuse and misuse while providing their patients relief from pain,” said Dr. Stefan Aigner, Chairman and CEO of Protega. “This combination of abuse-deterrent properties and clinical value for medically appropriate patients makes RoxyBond a reference of choice for prescribers and care givers.”
RoxyBond is an abuse-deterrent formulation of immediate-release oxycodone that uses physical and chemical barriers, without incorporating aversive agents or opioid antagonists. RoxyBond, which features SentryBond, a unique patent-protected abuse-deterrent technology, is formulated with inactive ingredients that make the tablet more difficult to manipulate for misuse and abuse, even if subjected to physical manipulation and/or chemical extraction.
Data from in vitro and clinical studies suggest that RoxyBond has physicochemical properties that are expected to make abuse via injection difficult and reduce abuse by the intranasal route of administration. However, abuse by the intranasal, oral and intravenous routes is still possible.
“We are prepared and incredibly excited to responsibly launch RoxyBond. Key stakeholders, including healthcare providers and payers, have responded favorably to the differentiated attributes of the RoxyBond label,” said Mike Innaurato, President and COO.
ROXYBOND is contraindicated in patients with significant respiratory depression, acute or severe bronchial, gastrointestinal obstruction and hypersensitivity (e.g., anaphylaxis) to oxycodone. These are not all the risks associated with use. Please see important safety information, including boxed warning and indication below.
RoxyBond should only be prescribed by healthcare professionals who are knowledgeable in the use of potent opioids for the management of pain.
The SentryBond technology platform combines inactive excipients with active pharmaceutical ingredients (API) in a tablet that is specifically designed to frustrate abuse for various methods of manipulation and routes of administration. SentryBond is designed to slow the intended immediate-release properties of RoxyBond when manipulated then insufflated compared to taking RoxyBond orally intact. SentryBond Technology imparts its abuse-deterrent characteristics via physical and chemical methods, without the use of antagonist or aversive agents. SentryBond technology is covered by an issued US patent, with additional US and global patent applications pending.
Protega is a privately held specialty pharmaceutical company that is dedicated to advancing solutions in the field of prescription drug abuse deterrence through continued innovation. Recognizing the serious unmet public health need to combat the escalating crisis of prescription opioid abuse and misuse, Protega began pioneering the development of novel abuse-deterrent technologies. For more information, visit at https://protegapharma.com/.
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