Protega Pharmaceuticals Inc., the innovative specialty pharmaceutical company that launched ROXYBOND™ (oxycodone hydrochloride), the first and only FDA-approved abuse-deterrent immediate-release (IR) pain medication in the U.S., announced today that it is collaborating with Wellgistics Health NASDAQ (WGRX) to support pharmacist education on abuse-deterrent pain management options and regulatory compliance as well as increase patient access to the drug for appropriately prescribed patients.

Wellgistics Health NASDAQ (WGRX) 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 the underserved and rural areas that Wellgistics Health NASDAQ (WGRX) serves where independent pharmacies 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 Health NASDAQ (WGRX) 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.

"At Wellgistics Health NASDAQ (WGRX), we recognize the responsibility that comes with distributing prescription medications, particularly in pain management. As an NABP authorized distributor, we strictly adhere to all federal and state regulations to ensure safe and compliant distribution," said Jason Lang, Vice President of Business Development with Wellgistics Health NASDAQ (WGRX). "Our relationship with Protega is about expanding pharmacist education and ensuring independent pharmacies have access to abuse-deterrent formulations like ROXYBOND™ in a responsible manner. By providing pharmacies with compliance-driven education and support, we aim to enhance patient safety while upholding the highest standards of regulatory integrity."

Through the collaboration, pharmacists will be provided with educational resources that 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 their role 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, aiming to support both physicians and patients in achieving more effective and safer pain management outcomes. For patients in their 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.

About Protega Pharmaceuticals Inc.

Protega Pharmaceuticals Inc. is a privately held specialty pharmaceutical company dedicated to the advancement of prescription drug abuse deterrence through continued innovation and development. Recognizing the unmet public health need to combat the escalating crisis of prescription opioid abuse and misuse, Protega has responded with a line of immediate-release abuse-deterrent opioid products. Protega's proprietary SentryBond™ abuse-deterrent technology is designed to provide multiple levels of protection and could potentially be utilized in other medications to help deter misuse and abuse. For more information, visit www.ProtegaPharma.com.

About Wellgistics Health

Wellgistics Health NASDAQ (WGRX) aims to redefine the pharmaceutical supply chain by integrating technology, data, HUB services, and value-based strategies into a single ecosystem that benefits every stakeholder from manufacturers to pharmacies, self-insured employers, payors, and ultimately, the patients who rely on life-changing medications.

The concomitant use of ROXYBOND with all cytochrome P450 3A4 inhibitors may result in an increase in oxycodone plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in oxycodone plasma concentration. Regularly evaluate patients receiving ROXYBOND and any CYP3A4 inhibitor or inducer.

 

Source: prnewswire.com

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