Shots:
- Abuse-deterrent products are prescription medications, primarily opioids and certain stimulants, designed to resist common methods of misuse, such as crushing, snorting, or injecting
- Protega Pharmaceuticals’ RoxyBond is the first and only FDA-approved, immediate-release abuse-deterrent opioid indicated for managing severe pain when alternative treatments are inadequate
- PharmaShots is pleased to feature Paul Howe, Chief Operations Officer at Protega Pharmaceuticals, who shares insights on the company’s SentryBond technology and its recent collaborations.
Saurabh: Protega Pharmaceuticals has earned quite a reputation for delivering immediate-release abuse-deterrent products. Could you highlight the gaps in pain management and the development of novel abuse-deterrent products?
Paul: At Protega, our mission is to become the leading pain management company in the United States by delivering innovative platforms that enhance total patient care, improve outcomes, and address challenges such as misuse, abuse, and diversion.
Those living with chronic pain face many barriers to getting the care they need. We are
working to collaborate with medical professionals to deliver novel abuse-deterrent therapies that enhance safety for patients, families, and communities, while preventing abuse and reducing avoidable deaths.
The development of abuse-deterrent formulations (ADFs) is a labor-intensive and risky endeavor. This includes a significant amount of laboratory, or in vitro testing to evaluate 1) how difficult it is to manipulate the formulation into a powder for snorting; 2) how difficult is it to extract the active pharmaceutical ingredient (API) from intact and manipulated tablets in larger volumes; and 3) how difficult is it to extract the API in small volumes to facilitate intravenous administration.
Each of these in vitro evaluations is performed by experienced laboratory scientists and, in general, all testing must prove that, relative to a non-abuse-deterrent formulation, the investigational product is expected to reduce misuse and abuse via nonoral routes of administration.
If the in vitro testing is successful, the FDA requires an in vivo pharmacokinetic study and often an in vivo human abuse potential (HAP) study to confirm that intentional misuse results reduced drug liking and take drug again scores, relative to the non-ADF. Not only are HAP studies difficult to design and perform, investigational ADF formulations must show both statistically significant and clinically meaningful reductions in drug liking (effect max, Emax) and take drug again (effect max, Emax). Failures in any of the thousands of in vitro tests or in vivo evaluations typically result in a product dossier that is not approvable by the FDA or other regulatory authorities. In recent history, the FDA has also convened an advisory committee (ADCOM) for ADFs. Unfortunately, the majority of ADCOMs have resulted in an overall ‘no’ vote from the FDA advisors, and many pharmaceutical sponsors have abandoned their ADF development programs.
It has been estimated by the CDC that 1 in 5 Americans who suffer from chronic pain have been left behind. In the past decade, opioid prescriptions went down almost 45%, leaving many chronic pain patients wondering where to find help.
ADFs are not a panacea, but they play an essential role in complementing existing risk mitigation strategies employed by healthcare providers, payers, and public health authorities. By making manipulation and non-medical use more difficult, ADFs provide an added layer of protection, helping to preserve access to effective pain relief while minimizing the potential for harm.
Saurabh: Would you like to talk about ROXYBOND, the first and only FDA-approved abuse-deterrent immediate release pain medication in the US?
Paul: RoxyBond is the first and only FDA-approved abuse-deterrent immediate-release opioid for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. It was developed to deter misuse and abuse while maintaining a positive benefit–risk profile for patients with severe pain.
Despite years of public health interventions, the U.S. continues to face an opioid epidemic with devastating consequences. According to CDC estimates, opioid-involved overdose deaths rose from approximately 69,700 in 2020 to a peak of over 81,800 in 2022, followed by a modest decline in 2023 to around 79,400. In 2024, opioid-related deaths dropped significantly to 54,743, marking nearly a 34% decrease from the previous year.
This encouraging decline is attributed largely to the wider availability and use of Naloxone,
which has saved countless lives by reversing opioid overdoses in emergency settings.
However, this drop does not reflect a meaningful reduction in opioid misuse or abuse, which
remains widespread, particularly with the persistent threat of synthetic opioids like fentanyl.
Saurabh: Please elaborate on Protega’s SentryBond technology platform.
Paul: RoxyBond is formulated with SentryBond abuse-deterrent technology. This patented technology combines inactive excipients with active pharmaceutical ingredients to make the tablet more difficult to manipulate for misuse and abuse, even if it is subjected to physical manipulation and/or chemical extraction. When physically manipulated, SentryBond is designed to maintain the intended release profile of extended-release products and delay the release of immediate-release products.
Protega’s innovative SentryBond technology is a first-of-its-kind, abuse-deterrent patented technology. It is designed to provide multiple levels of protection that resist physical manipulation, chemical extraction, and manipulation or transformation for injection. Protega’s SentryBond technology platform could potentially be utilized in other medications to help deter misuse and abuse, e.g., hydromorphone, hydrocodone, and attention deficit hyperactivity disorder (ADHD) medications. While these uses are currently not available and require FDA approval, the technology can help in a variety of medications.
Saurabh: Recently, Protega entered a collaboration with Wellgistics. Could you elaborate on the partnership?
Paul: One of our key strategic imperatives is offering multiple access points, including specialty, national chain, and independent distribution channels, to ensure that when physicians deem an abuse-deterrent necessary, we have multiple ways patients can access the medication.
As of July 15, 2025, we have added three specialty pharmacies located in 43 states that are assisting in distribution.
Saurabh: Could you shed light on Protega’s partnership with OPOS?
Paul: Protega teamed up with OPOS, a behavioral health and risk-monitoring software platform, earlier this year as its exclusive manufacturer and distributor of the OPOS software for interventional pain doctors.
OPOS offers comprehensive solutions to help providers effectively and safely manage patients utilizing long-term opioid therapy as part of a multimodal pain treatment plan. The OPOS platform addresses key challenges, including opioid prescribing regulatory compliance, risk management, patient monitoring, and patient education
Protega, in partnership with OPOS Solutions, is developing a framework to track key data points such as reduced ER visits, fewer missed workdays, and successful treatment transitions. This will offer a comprehensive view of effective pain management, balancing access with accountability. Protega’s collaboration with OPOS further underscores the company’s position as a pharmaceutical and medtech company focused on deterring prescription medication misuse and abuse.
Saurabh: Patients continue to have major concerns regarding accessibility in the pharmaceutical socioeconomic landscape. Can you tell me how you address patients’ needs, as I noticed that Protega offers Copay cards to patients who are in need of ROXYBOND?
Paul: In the U.S., 29 states have had some form of legislation to require insurance companies to cover abuse deterrent medication. Six states have legislation that has passed and have statutes with some form of insurance requirement.
On August 1, 2025, Louisiana became the first U.S. state to mandate the use of abuse-deterrent opioid medications – making it unlawful for an insurer to deny or substitute an abuse-deterrent opioid prescription deemed medically necessary and prescribed by a licensed physician.
The state’s mandate will help all those who live with chronic pain and have faced obstacles in obtaining the medication they need. Protega has the only FDA-approved immediate-release abuse-deterrent opioid that meets both Louisiana’s law in House Bill 423 and CDC guidelines which recommends that “clinicians should prescribe immediate-release opioids instead of extended-release and long-acting opioids.”
Protega has also contracted with two of the top three PBMs, Express Scripts and OptumRx, giving patients better access to our product. We also have a copay program to help commercial patients with access to the medication, where they pay a $10 copay.
Saurabh: Are you looking for collaborations to develop and commercialize novel abuse-deterrent products using your SentryBond technology platform?
Paul: Yes, we are reviewing collaborations and raising additional funds to start or collaborate with a partner on other immediate-release medications that are widely abused in the United States. Medications being considered are immediate-release hydrocodone and ADHD medication, such as Adderall (amphetamine/dextroamphetamine IR).
About the Author:
Paul Howe
Chief Operations Officer
As the Chief Operating Officer at Protega Pharmaceuticals, Paul leads operations for a med-tech company focused on responsible pain management with technology-based platforms and abuse-deterrent products. With 20 years of experience in the pharmaceutical industry, Paul has a proven track record of driving growth and innovation by integrating pharmaceutical and healthcare technology.
Related Post: Wearable Drug Delivery System: Mehul Desai from Enable Injections in a Riveting Conversation with PharmaShots
