The opioid crisis continues to claim lives and strain the healthcare system, despite national efforts to reduce overprescribing and improve oversight. Prescription medications are still a common entry point to misuse, with tampering often marking the turning point toward addiction. At the same time, patients living with chronic pain face growing barriers to care. Protega Pharmaceuticals aims to address both challenges with its SentryBond™ abuse-deterrent technology, FDA-approved RoxyBond® immediate-release oxycodone, and a software platform that supports safer, more accountable pain management. By combining medication innovation with patient-centered digital tools, Protega is redefining how pharma can help prevent misuse before it starts.
A Still Unfolding Crisis
More than two decades into the opioid epidemic, the crisis remains both a national emergency and a deeply personal tragedy for countless American families. In 2023, over 80,000 people in the United States died from opioid overdoses, including more than 14,000 linked specifically to prescription opioids.1,2 The numbers have held stubbornly high despite increased public awareness, tighter regulations, and widespread scrutiny of prescribing practices. In March 2025, the U.S. Department of Health and Human Services (HHS) and the Substance Abuse and Mental Health Services Administration (SAMHSA) reaffirmed the crisis as a public health emergency, citing persistently high overdose death rates and widening disparities in access to care.3,4
There have been important gains. The volume of opioids prescribed nationally has dropped significantly over the last decade, driven in part by revised Centers for Disease Control and Prevention (CDC) guidelines encouraging the use of lower doses and shorter treatment durations whenever possible.1 The Drug Enforcement Administration (DEA) has also implemented annual quota reductions for Schedule II controlled substances, further shrinking the availability of high-dose opioids in the supply chain. Prescribers today are more cautious, and the landscape of pain management has shifted in response.
Nonetheless, the crisis has not abated. One of the most persistent challenges is the diversion of prescription opioids from intended patients to others — most often family members or friends. According to federal data, 54% of people who misuse prescription opioids obtain them from someone else’s medication supply, frequently from unsecured household medicine cabinets.1 As a result, even responsible prescribing can lead to unintended harm, especially when potent medications remain in circulation after their therapeutic use ends.
Meanwhile, an unintended consequence of more stringent regulations has been the marginalization of legitimate pain patients. As providers seek to avoid scrutiny or run afoul of compliance guardrails, many patients with chronic or high-impact pain have found themselves with limited access to effective therapies.5 This is particularly concerning given the growing prevalence of pain in the United States, which increased from 20.4% of adults in 2019 to 24.3% in 2023, according to CDC tracking. The most severe cases — those classified as high-impact pain — now affect more than 8.5% of the adult population, with aging demographics and cumulative sports injuries both contributing to the trend.
While progress has been made in curbing the excesses of the past, pain itself has not diminished, and the tools to treat it remain imperfect, often carrying risk alongside relief. The next phase of the opioid response will require solutions that address not only supply and regulation, but also innovation in how we deliver, monitor, and manage pain therapies.
A Tipping Point: From Therapeutic Use to Tampering
For many, opioid misuse does not begin with illegal street drugs or immediate intent to abuse. It begins with a legitimate prescription, often for a routine injury, surgery, or chronic condition. In these cases, opioids are taken exactly as directed — at least at first. Unfortunately, as tolerance builds, pain persists, or curiosity takes hold, a subtle shift can occur. Patients may begin to manipulate their medication: crushing tablets for faster onset, snorting for a stronger high, or attempting to extract and inject the drug. This moment represents a critical inflection point: the transition from therapeutic use into dangerous misuse.
The mechanics of that shift matter. Oral tablets are designed for appropriate release through digestion. Tampering circumvents this process, rapidly delivering a high dose of the active opioid directly to the brain. That sudden rush is what many abusers seek, but it also dramatically raises the risk of overdose. Once a patient discovers that crushing or injecting a tablet can create a euphoric effect, the likelihood of further misuse increases significantly. For some, this becomes the gateway to illicit alternatives like heroin or fentanyl, both of which are cheaper, more accessible, and vastly more lethal.1,4
In this gray zone between legitimate medical use and outright abuse lies one of the most powerful and underutilized opportunities for intervention. Preventing or deterring the act of tampering itself can disrupt the trajectory toward addiction and overdose. It is at this moment, when a patient first experiments with altering a medication's form, that tools designed to resist manipulation can have a significant impact. The challenge for pharmaceutical companies is not just to develop effective pain therapies but to engineer them in ways that actively discourage their misuse without diminishing their value to patients who rely on them.
A New Kind of Pharma Mission
Protega Pharmaceuticals was not built to chase market share; it was founded to fill a void left by an industry reckoning with its past.6 Based in Princeton, New Jersey, the company was established by a team of life sciences veterans with experience across both Big Pharma and startup environments. Their collective experience spans decades of drug development, commercialization, and regulatory strategy, but what unites them at Protega is a shared commitment to societal impact.
The company’s mission is clear: to become the leading pain management company in the United States by delivering safe, responsible, and technology-driven solutions that help patients while reducing the risks of misuse, abuse, and diversion. In practice, this means more than simply producing effective medications; it means designing products that anticipate the ways in which they might be misused and incorporating protective features from the outset.
For Paul Howe, Protega’s Chief Operating Officer, the work is personal as well as professional. After years in senior commercial roles at firms like GlaxoSmithKline and AcelRx, he was drawn to Protega by the opportunity to help shape a company around a mission with real social consequence. “This isn’t just about building a company — it’s about preventing people from losing their loved ones,” Howe said. “That’s what drew me here.”
From that premise, Protega is building an integrated model of innovation, public health alignment, and patient advocacy that seeks to reset how the pharmaceutical industry approaches pain care.
Abuse-Deterrent Innovation at the Tablet Level
At the core of Protega’s approach is a proprietary drug formulation platform known as SentryBond™, designed to directly address the inflection point where legitimate opioid use can slide into dangerous misuse. SentryBond is a patented abuse-deterrent technology that incorporates inactive ingredients within each tablet. These ingredients remain inert during normal use but activate when the tablet is physically or chemically manipulated, triggering multiple defensive mechanisms.
If a tablet formulated with SentryBond is crushed and exposed to liquid — a common method for injection or nasal insufflation — it transforms into a thick, viscous gel that is extremely difficult to draw into a syringe or snort. In human abuse-potential studies, participants reported that tampered tablets significantly delayed the drug’s time to peak concentration and diminished its overall effect. That’s exactly the opposite of what users seeking euphoria are trying to achieve.
More than 2,000 in vitro tests were conducted during development, followed by extensive live testing with recreational drug users. When asked whether they would choose to use the manipulated version of the drug again, more than 80% of participants responded that they would not. Based on these findings, the FDA granted the product an official abuse-deterrent designation in line with the agency’s guidance on labeling for such formulations.
SentryBond's potential extends well beyond its first application. While it currently underpins RoxyBond, Protega's flagship oxycodone product, the company is exploring its potential use with other commonly misused substances. If successful, these extensions could offer meaningful advances in both opioid and non-opioid drug safety.
RoxyBond: A First-of-Its-Kind Product
RoxyBond stands alone in the current pharmaceutical landscape. It is the first and only immediate-release (IR) oxycodone formulation to receive FDA approval with abuse-deterrent labeling.7 In a market that accounts for approximately 40 million IR oxycodone prescriptions annually, RoxyBond is the only product offering built-in features specifically designed to reduce tampering and deter misuse.
The innovation lies not only in the abuse-deterrent characteristics, but also in the fact that patients using RoxyBond as prescribed experience no reduction in therapeutic benefit. The product is bioequivalent to standard oxycodone IR, delivering the same clinical performance in terms of onset, duration, and pain control. For prescribers and patients alike, this means that safety enhancements come without compromise.
Feedback from the field has been encouraging. Physicians treating elderly patients have noted the value of RoxyBond’s standardized appearance: same shape, same color, same tablet size every time. This consistency reduces the likelihood of medication confusion in vulnerable populations, particularly those managing multiple prescriptions. Among clinicians more broadly, RoxyBond is increasingly viewed as a valuable risk-mitigation tool, not only for individual patient care but also for institutional opioid stewardship programs seeking to reduce liability and improve safety protocols.
“With RoxyBond, we’re not trying to grow the opioid market — we’re trying to make it safer,” said Howe. “This product gives prescribers a responsible option when opioid therapy is truly needed.”
Monitoring Software Offers Solutions Beyond the Pill
While pharmaceutical innovation is critical to the development of new solutions to the crisis, medication alone cannot solve the complex challenges of chronic pain management. Patients with long-term pain conditions often struggle not only with access to care but also with inadequate monitoring, inconsistent follow-up, and the stigma that shadows opioid treatment. Many providers, wary of regulatory scrutiny or overwhelmed by administrative burdens, are reluctant to treat these patients, leaving some of the most vulnerable populations underserved.
Recognizing this gap, Protega partnered with OPOS Solutions, a behavioral health and risk-monitoring software platform developed in collaboration with clinicians from Stanford and Vanderbilt. OPOS is designed to support a new model of chronic pain care that balances safety, accountability, and compassion.
The platform enables physicians to enroll patients in a structured care program that includes monthly telehealth-based group therapy sessions, digital monitoring tools, and targeted clinical support. Patients complete assessments developed by psychometric experts, helping to track functional outcomes, behavioral health factors, and medication adherence. For clinicians, OPOS provides a real-time dashboard with visual risk stratification — green, yellow, or red flags that highlight which patients may require closer supervision or intervention. The platform also ensures thorough chart documentation that aligns with CDC guidelines and satisfies state medical board expectations.
“We’re offering a comprehensive approach to pain management that we hope will become the standard of care, and support how chronic pain is managed in this country,” said Howe.
By giving providers better visibility into their patients’ needs and progress, OPOS supports appropriate tapering and long-term engagement, while easing the administrative load on already strained practices. In early rollout, the platform has already been adopted by more than 20 clinics, with rapid expansion underway.
Driving Policy and Public Health Change
Protega’s work doesn’t stop at the clinic or the lab bench; it extends into the regulatory and legislative arenas, where real-world impact is often determined. The company has positioned itself not just as a pharmaceutical innovator but as a policy ally to agencies, lawmakers, and healthcare systems striving to navigate the complexities of opioid oversight.
Protega has worked closely with the DEA to advance shared goals around diversion prevention and education. To date, the company has conducted training and information sessions with more than 16 regional DEA offices, helping regulators better understand the mechanisms and public health rationale behind abuse-deterrent formulations. This cooperation has earned Protega credibility with enforcement bodies that historically viewed opioid manufacturers with skepticism.
Legislators across the country have also taken notice. In recent years, 29 states have introduced or passed legislation to support the use of abuse-deterrent formulations (ADFs), recognizing their potential to reduce harm when opioid prescribing is medically necessary. Most recently, Louisiana passed a new statute that goes even further. The law requires insurers to cover ADFs like RoxyBond when a prescriber identifies that a patient or their household is at elevated risk of misuse. The statute is among the strongest yet in mandating payer accountability and prioritizing patient safety.
Hospitals are likewise beginning to adopt Protega’s solutions within formal care protocols. A major health system in Louisiana has added RoxyBond to its outpatient opioid stewardship program, incorporating it as a preferred option for patients flagged as high-risk in the electronic medical record system. This integration represents an important step toward embedding abuse deterrence into institutional best practices, ensuring safer prescribing not just at the individual level, but system-wide.
Measuring Impact: Toward a New Set of Metrics
In a landscape still haunted by the legacy of irresponsible marketing and inflated prescribing, Protega is deliberately taking a different path, valuing outcomes over optics. The company is actively working to develop a new set of metrics that can better reflect the real-world impact of its technologies. These aren’t just sales figures or prescription counts but indicators of whether patients are actually safer, healthier, and more stable in their care.
Through its partnership with OPOS Solutions and collaborations with external research groups, Protega is building a framework to track meaningful data points, such as reductions in emergency room visits, fewer missed days of work, and evidence of successful titration or transition to lower-risk treatment. These markers can provide a more complete picture of whether pain is being managed effectively without enabling misuse, and whether the health system is functioning in a way that balances access with accountability.
At the same time, the company is looking ahead. With the SentryBond platform already validated in the context of oxycodone IR, Protega is pursuing development pathways for additional drug classes, including hydrocodone and potentially stimulant medications for ADHD. Beyond the United States, early conversations are underway about expanding into European markets, particularly in the UK, where prescription opioid misuse is now on the rise.
“We may not be able to measure lives saved yet,” Howe said. “But we’re building the tools to learn—and that’s how we’ll make the case for a better standard of care.”
Protega’s Patient-Centered Model of Change
Protega Pharmaceuticals represents a different kind of approach to pain management that refuses to treat medication in isolation from the broader patient experience. By integrating scientifically advanced drug formulations with proactive monitoring tools and a clearly defined social mission, the company is constructing a model of care built around prevention, accountability, and long-term safety.
This is a company focused on guardrails, not gateways, seeking to give providers a way to help patients manage pain without sliding unknowingly — or unintentionally — toward addiction. In doing so, Protega is also contributing to a broader rethinking of the pharmaceutical industry’s role in public health.
References
1. “Understanding the Opioid Overdose Epidemic.” Centers for Disease Control and Prevention. 1 Nov. 2024.
2. Ahmad FB, JA Cisewski, LM Rossen, and P Sutton. “Provisional Drug Overdose Death Counts.” National Center for Health Statistics. 11 Jun. 2025.
3. Secretary Kennedy Renews Public Health Emergency Declaration to Address National Opioid Crisis. Substance Abuse and Mental Health Services Administration. 18 Mar. 2025.
4. Canada–U.S. Joint White Paper: Substance Use and Harms During COVID-19 Pandemic and Approaches to Federal Surveilance and Response. U.S. Department of Health and Human Services, Health Canada, and Public Health Agency of Canada. 2022.
5. Minster, Sarah. “Where Does the Opioid Crisis Stand Today in Local Communities?” National League of Cities. 18 Feb. 2025.
7. Roxybond.com