Wellgistics Health, Inc. announced that its wholly owned subsidiary, Wellgistics LLC, is collaborating with Protega Pharmaceuticals Inc. Protega is the specialty pharmaceutical company that launched ROXYBOND™ (oxycodone hydrochloride), the first and only FDA-approved abuse-deterrent immediate-release (IR) opioid pain medication in the U.S. The collaboration is meant to support pharmacist education on abuse-deterrent pain management options and regulatory compliance as well as increase patient access to ROXYBOND™ for appropriately prescribed patients.
Wellgistics LLC is a pharmaceutical wholesaler and National Association of Boards of Pharmacy (“NABP”) authorized distributor that serves over 5,400 independent pharmacies across all 50 states. The relationship will support education to these pharmacies and help provide distribution of ROXYBOND™ to appropriately prescribed patients, particularly in underserved and rural areas where Wellgistics LLC’s independent pharmacy clients play a critical role in patient care.
“We are excited to commence our first collaboration with an NABP authorized distributor that aligns perfectly with our mission to make the opioid market safer,” said Paul Howe, Chief Commercial Officer of Protega. "Considering the complexities surrounding pain management and opioid prescribing, it is critical that independent pharmacists are equipped with evidence-based education to help make informed decisions that support public health objectives. Our joint mission with Wellgistics LLC addresses this need and represents a significant milestone in further support of a controlled, compliant, and responsible distribution network for abuse-deterrent pain management solutions.”
More states are introducing legislation addressing insurance companies’ coverage of abuse-deterrent products for pain management, if available. With a focus on responsible pain management and the development of novel products formulated with its patented SentryBond™ abuse-deterrent technology, Protega introduced ROXYBOND™ which is the only FDA-approved line of IR opioids.
"Regulatory integrity and patient safety are the foundation of everything we do at Wellgistics Health (NASDAQ: WGRX). As an NABP-authorized distributor, and utilizing a fully serialized ERP for supply chain traceability —we ensure independent pharmacies have the tools, education, and access they need to dispense medications like ROXYBOND™ responsibly,” said Brian Norton, Chief Executive officer of the Company. Our agreement with Protega is a prime example of how we deliver value across the entire pharmacy ecosystem—connecting drug manufacturers with our compliance, education, and access in a way that protects patients and empowers pharmacists to operate with confidence and integrity.”
Through the collaboration, pharmacists will be provided with educational resources that both incorporate applicable FDA regulations, DEA guidelines, and best practices in responsible opioid dispensing and inform pharmacists about FDA-approved abuse-deterrent formulations like ROXYBOND™ and the role of these formulations in pain management.
The educational focus will encompass both ROXYBOND™ and responsible pain management as a whole, emphasizing safe and effective pain treatment options while mitigating risks, the role of abuse-deterrent formulations (ADF) in public health strategies, and pharmacist responsibilities in preventing misuse, diversion, and overprescribing.
Protega’s innovative SentryBond™ technology platform integrates inactive excipients with active pharmaceutical ingredients in a tablet that is specifically designed to frustrate abuse via various methods of manipulation and routes of administration. When subjected to manipulation and/or attempts at extraction, the formulation is designed to maintain the intended release profile of extended-release products and to delay the release of immediate-release products. However, abuse is still possible by intranasal, intravenous, and oral routes.
On September 5, 2024, the FDA approved a new 10 mg strength of ROXYBOND™, expanding Protega’s line of abuse-deterrent IR opioids, which also includes 5 mg, 15 mg, and 30 mg tablet options. ROXYBOND™’s availability in four dosages can enhance flexibility and precision in opioid therapy, by aiming to support both physicians and patients in achieving more effective and safer pain management outcomes. Depending on a patient’s individual circumstances, the range of doses may provide better options for pain control, reduce the risk of side effects by finding the lowest effective dose, and provide a smoother transition during dosing transitions. For physicians, it can allow for more flexible dosing for pain levels, better titration, and help optimize risk management across diverse patient populations.