Protega Pharmaceuticals Secures FDA Approval for ROXYBOND™ (oxycodone hydrochloride) Immediate-Release 10 mg Tablet Incorporating Abuse-Deterrent Technology for Effective Pain Management.
The innovative SentryBond™ technology, pioneering in the field of abuse-deterrent solutions, offers various layers of protection against misuse and has promising applications in other pharmaceutical formulations.
With SentryBond technology, ROXYBOND stands as the solitary FDA-approved immediate-release opioid with robust abuse-deterrent capabilities, aimed at curbing the potential for misuse.
PRINCETON, N.J., Oct. 29, 2024 /PRNewswire/ — Protega Pharmaceuticals Inc., an avant-garde specialty pharmaceutical firm dedicated to advancing responsible pain management and pioneering innovative abuse-deterrent medications, proudly announces that the U.S. Food and Drug Administration (FDA) has granted approval for ROXYBOND™ (oxycodone hydrochloride) immediate-release (IR) CII 10 mg tablet. This formulation is indicated for the management of severe pain that necessitates opioid analgesics and for which alternative treatment methods fall short. As the only FDA-sanctioned abuse-deterrent immediate-release 10 mg oxycodone product, ROXYBOND is anticipated to significantly diminish abuse through both intranasal and intravenous channels.*
ROXYBOND tablet formulation employs the SentryBond™ abuse-deterrent technology, a patented innovation that integrates inactive excipients and active pharmaceutical ingredients, making the tablet resistant to manipulation for misuse. This advanced technology not only reinforces the intended release profile of extended-release (ER) formulations but also controls the release mechanism in immediate-release products.
“The FDA endorsement of ROXYBOND 10 mg with SentryBond marks a pivotal achievement for Protega, addressing a significant gap in the market for an IR opioid equipped with abuse-deterrent technology that can potentially mitigate misuse and abuse, all while delivering effective pain relief to appropriately selected patients,” stated Paul Howe, Chief Commercial Officer of Protega. “Our pioneering technology complicates manipulation tactics, rendering the pill less amenable to harmful practices like cutting or crushing for inhalation or injection.”
The proprietary SentryBond technology is groundbreaking in its dual approach for abuse deterrence. It focuses on mitigating risks associated with physical and chemical manipulation that could lead to injection or misuse. The versatile SentryBond platform has the potential for adaptation across a range of pharmacological products, including other opioids and ADHD medications. Although seeking FDA approvals for these applications, its innate capabilities represent a significant step forward in combating abuse across the pharmaceutical industry.
“The successful development of ROXYBOND utilizing SentryBond technology is a crucial advancement in the ongoing battle against the nationwide epidemic of prescription opioid overdose,” remarked Eric Kinzler, Ph.D., VP of Medical and Regulatory Affairs at Protega. “We are wholly committed to blocking pathways to misuse and abuse, working collaboratively with healthcare professionals to diminish these challenges. Our team eagerly anticipates the responsible launch of ROXYBOND 10 mg while continuing to elevate our innovative technology platform for application in other widely misused prescription medications.”
Extensive in vitro research, exceeding 2000 tests, substantiates that ROXYBOND tablets present considerable challenges to manipulation in comparison to conventional oxycodone IR formulations. This data, corroborated by findings from human abuse potential studies, suggests that the physicochemical properties of ROXYBOND are poised to reduce abuse via intranasal and intravenous administration routes. That said, the prospect for abuse remains, particularly through intranasal, intravenous, and oral pathways.2
The introduction of ROXYBOND 10 mg aims to enhance both precision and flexibility in opioid therapy, effectively assisting healthcare providers and patients in attaining improved pain management outcomes. For patients, the availability of varied dosages facilitates more effective pain control, minimizes adverse side effects, and ensures smoother transitions between dosing regimens. For physicians, this formulation provides greater flexibility in addressing pain levels, more effective titration, and optimizing risk management across different patient demographics.
Please refer to the Important Safety Information and comprehensive Prescribing Information, including the BOXED WARNING and Medication Guide, available at www.ProtegaPharma.com.
About Protega Pharmaceuticals Inc.
As a privately held specialty pharmaceutical firm, Protega Pharmaceuticals Inc. is committed to enhancing prescription drug abuse deterrence through ongoing innovation and the development of solutions that resonate with current public health demands. With an acute awareness of the pressing need to address the epidemic of prescription opioid misuse and abuse, Protega has stepped forward with a suite of immediate-release abuse-deterrent opioid products. The pioneering SentryBond abuse-deterrent technology serves to provide multifaceted protection and has potential applications across numerous medications aimed at reducing misuse and abuse. For further details, visit www.ProtegaPharma.com.
References:
- RoxyBond [package insert]. Princeton, NJ: Protega Pharmaceuticals Inc.; 2024.
- Data on file. Protega Pharmaceuticals LLC.
*Abuse is still a concern through intranasal, intravenous, and oral routes.
INDICATION
ROXYBOND™ is specifically approved for addressing pain severe enough to necessitate opioid treatment when alternative options are ineffective.
Limitations of Use
Given the risk of addiction, abuse, and misuse with opioid medications, which can occur at any dosage or duration, reserve ROXYBOND for patients where alternative treatment methods (e.g., non-opioid analgesics or combination products) have been ineffective or poorly tolerated.
ROXYBOND should not be utilized long-term unless the patient’s pain remains severe enough to justify its use, and no alternative treatment options have proven adequate.
IMPORTANT SAFETY INFORMATION
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF ROXYBOND
Addiction, Abuse, and Misuse
The usage of ROXYBOND exposes users to considerable risks of opioid addiction, abuse, and misuse, leading to overdose and fatalities; it is vital to evaluate each patient’s risk before prescribing and to conduct routine reassessments for any signs of such behaviors or conditions.
Life-Threatening Respiratory Depression
Severe, life-threatening, or fatal respiratory depression is a potential risk with ROXYBOND usage, particularly during the initiation phase or following increased dosages. To minimize this risk, it is critical to ensure appropriate dosing and gradual titration of ROXYBOND.
Accidental Ingestion
Even a single dose of ROXYBOND ingested by someone, particularly children, may lead to a life-threatening overdose of oxycodone.
Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants
Combining opioids with benzodiazepines or other central nervous system (CNS) depressants may result in extreme sedation, respiratory suppression, comatose states, or death. Reserve concurrent prescriptions of ROXYBOND and benzodiazepines or other CNS depressants solely for patients lacking adequate treatment alternatives.
Neonatal Opioid Withdrawal Syndrome (NOWS)
Continuous use of opioids during pregnancy poses a risk for NOWS in infants, which can be fatal if not adequately managed. Proper management protocols from neonatal specialists should be ensured at delivery.
Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)
Healthcare providers must engage in a REMS-compliant educational initiative to counsel patients and caregivers on serious risks and safe usage and to underline the importance of the Medication Guide received with each prescription.
Cytochrome P450 3A4 Interaction
Co-administration of ROXYBOND with CYP3A4 inhibitors elevates oxycodone plasma levels, potentially increasing adverse reactions and causing fatal respiratory depression. Likewise, ending a CYP3A4 inducer’s use may increase plasma concentrations of oxycodone.
CONTRAINDICATIONS
ROXYBOND is contraindicated in individuals exhibiting:
- Significant respiratory depression
- Severe bronchial asthma under unmonitored scenarios or without resuscitative capabilities or hypercarbia
- Known or presumed gastrointestinal obstruction, including paralytic ileus
- Documented hypersensitivity (e.g., anaphylactic reactions) to oxycodone
WARNINGS AND PRECAUTIONS
Addiction, Abuse, and Misuse
ROXYBOND, classified as a Schedule II controlled substance, inherently carries risks of addiction, abuse, and misuse.
Given that the potential for addiction in any patient remains uncertain, individuals may become dependent on ROXYBOND even when prescribed in alignment with recommended guidelines. Proper evaluation of each patient’s risk for addiction and regular screening for signs of addictive behavior are essential practices.
Patients with a viability for substance abuse, including personal or family histories, are at a heightened risk for addiction with ROXYBOND usage. Patients with elevated risk may be eligible for opioid prescriptions like ROXYBOND, yet come with the necessity for rigorous counseling and consistent monitoring for symptoms of addiction or misuse. Consider prescribing naloxone as a precautionary measure for emergencies in cases of overdose.
As opioids can be diverted for non-medical use, the potential exists for ROXYBOND to be misused. Mitigation strategies may encompass prescribing limited quantities and emphasizing proper drug storage and disposal protocols.
Life-Threatening Respiratory Depression
ROXYBOND has been associated with serious and potentially fatal respiratory depression, particularly when commencing treatment or increasing dosages. If respiratory depression becomes evident, emergency interventions may include observation and support measures.
Educate caregivers on identifying respiratory depression and prompt action for emergency medical assistance in instances of suspected overdose.
Patient Access to Naloxone for Emergency Treatment of Opioid Overdose
Healthcare providers should discuss with patients and caregivers the availability of naloxone for addressing opioid overdose emergencies, assessing the need for access to naloxone at the start of treatment and during renewal of medication. It’s important to inform them about the methods of obtaining naloxone as guided by state-specific regulations.
Consultation about naloxone access should take the patient’s risk factors for overdose into account, including concurrent medication with CNS depressants or a history of opioid use disorders.
Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants
Careful advising to patients about the risks of profound sedation and respiratory depression when combining ROXYBOND with CNS depressants, including benzodiazepines and alcohol, is crucial. Recommendations should indicate that patients refrain from operating machinery until awareness of how these combinations affect their cognitive and physical abilities is established.
Neonatal Opioid Withdrawal Syndrome
Long-term opioid use during pregnancy can result in withdrawal symptoms in newborns, necessitating expert care and protocols during delivery. Guidance for pregnant patients on the risks associated with prolonged opioid use should be emphasized.
Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)
To ensure opioid analgesics benefits outweigh addiction, abuse, and misuse risks, the FDA mandates a REMS for all approved products in this category. Drug companies must provide REMS-compliant educational initiatives for healthcare providers.
Education should include specific discussions about safe use, serious risks, and the proper storage and disposal of opioid analgesics. Information and resources can facilitate better patient awareness and compliance.
Risks of Concomitant Use or Discontinuation of Cytochrome P450 3A4 Inhibitors and Inducers
Interaction with CYP3A4 inhibitors can elevate plasma concentrations of oxycodone, exacerbating adverse effects and potentially resulting in respiratory depression or overdose risk.
The opposite can occur with the discontinuation of CYP3A4 inducers, which may lead to withdrawal symptoms and inadequate pain control in those dependent on oxycodone.
Adrenal Insufficiency
Adrenal insufficiency can arise following prolonged opioid opioid use; symptoms typically present in nonspecific ways and should be promptly diagnosed and treated.
Severe Hypotension
Patients may experience severe hypotension from ROXYBOND, particularly vulnerable patients include those with specific comorbidities or concurrent usage of CNS depressant medications.
Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness
ROXYBOND therapy may exacerbate intracranial pressure and should be cautiously administered to patients with known conditions affecting consciousness or neurological status.
Risks of Use in Patients with Gastrointestinal Conditions
The use of ROXYBOND is contraindicated in individuals with gastrointestinal tract obstructions. Careful evaluation is necessary for patients with underlying biliary tract diseases post-administration.
Increased Risk of Seizures in Patients with Seizure Disorders
Oxycodone has been linked to higher seizure frequencies in patients with pre-existing seizure disorders, necessitating regular monitoring for seizure control during ROXYBOND therapy.
Withdrawal
Patients dependent on opioids should not halt ROXYBOND treatment abruptly. A gradual tapering method is crucial to avoid withdrawal symptoms and pain recurrence.
Risks of Driving and Operating Machinery
ROXYBOND affects mental and physical capabilities essential for driving or operating machinery, necessitating caution among patients until their treatment response is fully understood.
ADVERSE REACTIONS
DRUG INTERACTIONS
Combining ROXYBOND with potent CYP3A4 or CYP2D6 inhibitors increases plasma levels of oxycodone, raising the risk of severe adverse effects and possible respiratory depression, especially when initiated after a stable dose has been established.
The use of benzodiazepines, in tandem with ROXYBOND, may create additive pharmacologic interactions, enhancing the likelihood of severe outcomes including respiratory depression and coma.
Please refer to the complete Prescribing Information, including BOXED WARNINGS for further Important Safety Information and Medication Guide at www.protegapharma.com.
To report SUSPECTED ADVERSE REACTIONS, please contact Protega Pharmaceuticals Inc. at 1-844-798-3610 or the FDA at 1-800-FDA-1088 or visit www.fda.gov/safety.
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