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Nutriband Announces Data Supporting Need for Safer Abuse-Deterrent Transdermal Patches Presented at 2024 American Academy of Pain Medicine Annual Meeting



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Data highlights the incidence of abuse and accidental pediatric exposure of transdermal patches containing opioid and stimulant drugs


Nutriband's AVERSA(TM) technology addresses the unmet need for safer abuse-deterrent transdermal patches


ORLANDO, FL / ACCESSWIRE / March 25, 2024 / Nutriband Inc. (NASDAQ:NTRB)(NASDAQ:NTRBW), a company engaged in the development of prescription transdermal pharmaceutical products, today announced that data on the incidence of transdermal patch abuse and accidental pediatric exposure was presented at the 2024 American Academy of Pain Medicine (AAPM) Annual Meeting on March 8, 2024. The American Academy of Pain Medicine (AAPM) is dedicated to advancing multidisciplinary pain care, education, advocacy, and research.


The data indicate that transdermal patch abuse and accidental pediatric exposures to patches continue to be a serious problem resulting in major medical outcomes and death, suggesting an unmet need for safer abuse-deterrent versions of transdermal patches containing drugs with a risk of abuse, misuse or accidental exposure.


Nutriband's lead product is AVERSA(TM) Fentanyl which combines Nutriband's proprietary AVERSA(TM) abuse-deterrent transdermal technology with an already FDA-approved transdermal fentanyl patch and has the potential to become the world's first opioid patch with abuse-deterrent properties.AVERSA(TM) Fentanyl is estimated to have the potential to reach peak annual US sales of $80M - $200M.(1)


"As the data presented clearly illustrates, based on poison control call center information, abuse and overdose is a real problem with transdermal fentanyl as well as other transdermal opioid and stimulant products. Also, the incredible amount of accidental pediatric exposures, along with the major health outcomes associated with them, is alarming. We believe our Aversa abuse-deterrent technology will have a substantial impact on both of these unfortunate and preventable situations and will help reduce the risk of harm from fentanyl patches by providing taste aversion agents in every patch," said Gareth Sheridan, CEO, Nutriband.


Nutriband is developing its proprietary Aversa(R) abuse-deterrent transdermal technology which can be incorporated into any transdermal patch that contains any drug with a risk of abuse, misuse or accidental exposure. Its Aversa(R) product development pipeline includes abuse-deterrent versions of currently approved and marketed transdermal patches containing fentanyl, buprenorphine and methylphenidate which are labeled with FDA-required warnings for the risk of abuse and misuse, as well as warnings against accidental exposure.


Transdermal patches are designed to provide an alternative route of administration for opioid or stimulant drugs that are prescribed for treatment of conditions such as chronic pain, opioid use disorder or attention deficit/hyperactivity disorder. Although transdermal versions offer improved pharmacokinetic delivery as well as patient convenience with wear times of up to 7 days, they contain an increased drug payload which can often be a target for recreational drug abusers or subject to accidental pediatric exposure, particularly with infants and toddlers. Abuse of opioids, and in particular fentanyl abuse and overdose, continues to be an epidemic which can lead to the abuse of prescription transdermal fentanyl and other opioid containing transdermal products.


According to the FDA(1) , accidental exposure to medication is a leading cause of poisoning in children. Young children, in particular, have died or become seriously ill after being exposed to a skin patch containing fentanyl, a powerful opioid pain reliever. Children can overdose on new and used fentanyl patches by putting them in their mouth or sticking the patches on their skin. This can cause death by slowing the child's breathing and decreasing the levels of oxygen in their blood.


Nutriband abuse-deterrent transdermal technology consists of a proprietary aversive agent coating that employs taste aversion to deter the oral abuse of and accidental exposure to transdermal opioid and stimulant patch products. Preliminary studies have shown that the coating is very difficult to scrape off and the technology has a patented immediate and extended-release profile which presents an additional layer of deterrence to prevent the aversive layer from easily being washed off in an attempt to separate the drug from the aversive agents.


The company engaged Rocky Mountain Poison & Drug Safety (RMPDS), a division of Denver Health and Hospital Authority, Denver, Colorado to determine the incidence of abuse and accidental pediatric exposure of transdermal patches containing drugs of abuse in the United States based on poison center data for the surveillance period 2018-2022. RMPDS utilized the Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS(R)) System, a surveillance system that collects real-world safety and effectiveness data about prescription drugs (https://www.radars.org/).


Key findings from the study include:

   -- Major medical outcome or death resulted from a notable proportion of 
      fentanyl and buprenorphine patch intentional exposures and accidental 
      pediatric exposures 
 
   -- Two deaths were reported due to abuse of fentanyl transdermal patches 
 
   -- Oral abuse accounted for 62.5% of all intentional abuse/misuse event 
      reports for fentanyl patches (85.3% of non-dermal routes of abuse) 
 
   -- A notable proportion of accidental pediatric exposures to transdermal 
      formulations resulted in major medical outcomes (fentanyl patches: 10.1%, 
      buprenorphine patches: 16.7%) 

The AAPM poster can be found here: https://www.radars.org/system/...


(1) Health Advances Aversa Fentanyl market analysis report 2022



About AVERSA(TM) Abuse-Deterrent Transdermal Technology


Nutriband's AVERSA(TM) abuse-deterrent transdermal technology can be utilized to incorporate aversive agents into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential. The AVERSA(TM) abuse-deterrent technology has the potential to improve the safety profile of transdermal drugs susceptible to abuse, such as fentanyl, while making sure that these drugs remain accessible to those patients who really need them. The technology is covered by a broad intellectual property portfolio with patents granted in the United States, Europe, Japan, Korea, Russia, Canada, Mexico, and Australia.


About Nutriband Inc.


We are primarily engaged in the development of a portfolio of transdermal pharmaceutical products. Our lead product under development is an abuse-deterrent fentanyl patch incorporating our AVERSA(TM) abuse-deterrent technology. AVERSA(TM) technology can be incorporated into any transdermal patch to prevent the abuse, misuse, diversion, and accidental exposure of drugs with abuse potential.


The Company's website is www.nutriband.com. Any material contained in or derived from the Company's websites or any other website is not part of this press release.


Forward-Looking Statements


Certain statements contained in this press release, including, without limitation, statements containing the words "believes," "anticipates," "expects" and words of similar import, constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve both known and unknown risks and uncertainties. The Company's actual results may differ materially from those anticipated in its forward-looking statements as a result of a number of factors, including those including the Company's ability to develop its proposed abuse-deterrent fentanyl transdermal system and other proposed products, its ability to obtain patent protection for its abuse technology, its ability to obtain the necessary financing to develop products and conduct the necessary clinical testing, its ability to obtain Federal Food and Drug Administration approval to market any product it may develop in the United States and to obtain any other regulatory approval necessary to market any product in other countries, including countries in Europe, its ability to market any product it may develop, its ability to create, sustain, manage or forecast its growth; its ability to attract and retain key personnel; changes in the Company's business strategy or development plans; competition; business disruptions; adverse publicity and international, national and local general economic and market conditions and risks generally associated with an undercapitalized developing company, as well as the risks contained under "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in the Company's Form S-1, Form 10-K for the year ended January 31, 2023, filed April 26, 2023, the Forms 10-Q's filed subsequent to the Form 10-K in 2023, and the Company's other filings with the Securities and Exchange Commission. Except as required by applicable law, we undertake no obligation to revise or update any forward-looking statements to reflect any event or circumstance that may arise after the date hereof.

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