Full Press Release Details
Pharmaceuticals collaborates with Wellgistics to support pharmacist education and increase patient access to the first and only FDA-approved
abuse-deterrent immediate-release opioid, ROXYBOND
formulated with patented, first-of-its-kind abuse-deterrent technology SentryBond , is designed to provide multiple
levels of protection
New Jersey, March 04, 2025 (GLOBE NEWSWIRE) - Wellgistics Health, Inc. (NASDAQ: WGRX, the "Company"), a holding
company for various existing and planned strategic businesses centered around healthcare technology and pharmaceutical services, today
announced that its wholly owned subsidiary, Wellgistics LLC, is collaborating with Protega Pharmaceuticals Inc. ("Protega").
Protega is the innovative 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.
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.
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
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.
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."
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.
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.
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
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.
Protega Pharmaceuticals Inc.
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.
Wellgistics Health, Inc.
Health, Inc. is a holding company for existing and future planned operating companies centered around healthcare technology and pharmaceutical
services. It seeks to be a micro health ecosystem, with a portfolio of companies consisting of a technology platform, pharmacy, and wholesale
operations that provide novel prescription hub and clinical services. The Company is focused on improving the lives of patients while
delivering unique solutions for pharmacies, providers, pharmaceutical manufacturers, and payors. With the successful integration of its
patient-centric approach and innovative healthcare applications, the Company intends to shift the dynamic of pharmaceutical care to revolve
around the patient for a wide range of therapeutic conditions by offering a full spectrum of integrated solutions as a result of leveraging
the synergies of its business segments to address access, care coordination, dispensing, delivery, and clinical management of pharmaceutical
products ranging from "specialty-lite" to general maintenance conditions. Wellgistics LLC is a wholly owned subsidiary of
the Company, focusing on wholesale operations including the distribution and fulfillment of certain pharmaceutical medications to a network
of independent pharmacies. For more information, please visit the Company's website at www.wellgisticshealth.com and Wellgistics
LLC's website at www.wellgistics.com.
press release contains forward-looking statements. Forward-looking statements include statements concerning plans, objectives, goals,
strategies, future events or performance, and underlying assumptions and other statements that are other than statements of historical
facts. When the Company uses words such as "may, "will, "intend," "should," "believe,"
"expect," "anticipate," "project," "estimate" or similar expressions that do not relate
solely to historical matters, it is making forward-looking statements. These forward-looking statements include, without limitation,
the Company's statements regarding the potential benefits of ROXYBOND as well as the Company's strategy
and descriptions of its future operations, prospects, and plans.. Forward-looking statements are not guarantees of future performance
and involve risks and uncertainties that may cause the actual results to differ materially from the Company's expectations discussed
in the forward-looking statements. These statements are subject to uncertainties and risks including, but not limited to, the uncertainties
related to market conditions and other factors discussed in the "Risk Factors" section of the registration statement filed
with the SEC. For these reasons, among others, investors are cautioned not to place undue reliance upon any forward-looking statements
in this press release. Additional factors are discussed in the Company's filings with the SEC, which are available for review at
www.sec.gov. The Company undertakes no obligation to publicly revise these forward-looking statements to reflect events or circumstances
that arise after the date hereof.
is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
of the risks of addiction, abuse, and misuse with opioids, which can occur any dosage or duration, reserve ROXYBOND for use in patients
for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products):
should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which
alternative treatment options continue to be inadequate.
SERIOUS AND LIFE-THREATENING RISKS FROM USE OF ROXYBOND
the use of ROXYBOND exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose
and death, assess each patient's risk prior to prescribing and reassess all patients regularly for the development of these behaviors
Respiratory Depression
life-threatening, or fatal respiratory depression may occur with use of ROXYBOND, especially during initiation or following a dosage
increase. To reduce the risk of respiratory depression, proper dosing and titration of ROXYBOND are essential.
ingestion of even one dose of ROXYBOND, especially by children, can result in a fatal overdose of oxycodone.
From Concomitant Use With Benzodiazepines Or Other CNS Depressants
use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation,
respiratory depression, coma, and death. Reserve concomitant prescribing of ROXYBOND and benzodiazepines or other CNS depressants for
use in patients for whom alternative treatment options are inadequate.
Opioid Withdrawal Syndrome (NOWS)
opioid use is required for an extended period of time in a pregnant woman, advise the patient of the risk of NOWS, which may be life-threatening
if not recognized and treated. Ensure that management by neonatology experts will be available at delivery.
Analgesic Risk Evaluation and Mitigation Strategy (REMS)
providers are strongly encouraged to complete a REMS-compliant education program and to counsel patients and caregivers on serious risks,
safe use, and the importance of reading the Medication Guide with each prescription.