Verde Environmental Technologies Issues Public Comment on FDA Notice

WASHINGTON, Dec. 8 -- Jason Sundby, chairman and CEO of Verde Environmental Technologies Inc., Minnetonka, Minnesota, has issued a public comment on the Food and Drug Administration notice entitled "Reconsidering Mandatory Opioid Prescriber Education Through a Risk Evaluation and Mitigation Strategy in an Evolving Opioid Crisis; Public Workshop; Request for Comments". The comment was written on Dec. 3, 2021, and posted on Dec. 6, 2021:

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On behalf of Verde Environmental Technologies, Inc., maker of the Deterra Drug Deactivation System, I am writing to provide input as the Food and Drug Administration (FDA) considers requiring mandatory, opioid-related prescriber education as a part of a Risk Evaluation and Mitigation Strategy (REMS). We thank the agency for convening a public workshop on this topic on October 13-14, 2021 and appreciate the opportunity to provide comments. As you consider mandatory prescriber education, we strongly encourage you to incorporate requirements for co-dispensing of at-home opioid disposal systems which can deactivate these drugs and reduce the risk of inappropriate use, addiction, and overdose. This is an immediately available opportunity for the agency to implement the authority Congress provide in Section 3032 of the SUPPORT Act (P.L. 115-271).

Background on Deterra(R)

The Deterra(R) Drug Deactivation System(R) ("Deterra") is a U.S.-manufactured, evidence-based solution to remove unused and unwanted prescription drugs from the home. Our Deterra pouches use organic proprietary activated carbon that, when mixed with water, deactivate drugs so they can be safely disposed with normal household trash. In addition, Deterra is safer for the environment because it uses a U.S. Department of Agriculture-certified bio-based, environmentally sound packaging and prevents harmful medications from contaminating landfills and water systems. Deterra was developed under two Small Business Innovation Research contracts (Contract N43DA-13-4420/i and Contract N44DA-14-4420)/ii from the National Institute on Drug Abuse (NIDA)./iii

The activated carbon used within the Deterra system has shown to be highly effective in deactivating all chemical classes and forms of drugs tested including tabs, capsules, liquid, patches, and sublingual dosage units. The mean deactivation of active pharmaceutical ingredients and delivery formulations by activated carbon across all products tested was 99.6% at day 28 (see Figure 1)./iv

The pharmaceuticals adsorbed within the activated Deterra pouch are resistant to leaching by water, 30% ethanol, or other means, with only trace amounts detectable after an extensive washout.

Not only does Deterra effectively render drugs non-retrievable for misuse, abuse, or diversion, it also helps change behavior that will be a critical component to the success of the agency's efforts to better educate and protect beneficiaries. Research published in JAMA Pediatrics/v and JAMA Surgery/vi demonstrates the positive effect at-home drug disposal tools have in increasing prescription opioid disposal, especially when compared to traditional messaging and disposal approaches.

The JAMA Surgery authors identified a 3.8-times greater likelihood of opioid disposal as compared to the control arm receiving usual care. More than 57.1 percent of those individuals self-reported opioid disposal following a surgical procedure compared to 28.6 percent in the control. Results from JAMA Pediatrics indicated that greater than 85 percent of participants receiving Deterra properly disposed of their prescription.

The Need for At-Home Disposal

At-home disposal is a key component of the fight against the opioid epidemic, especially given the additional challenges presented by the COVID-19 pandemic. Roughly 70 percent of opioids prescribed for surgical use are leftover or unused/vii and more than 60 percent of people kept pills for future use rather than disposing of them. One in five of those people reported that they shared their medication with another person./viii

During the pandemic, access to drug disposal has become more limited as traditional drug disposal events such as Drug Enforcement Agency-sponsored takeback days have been cancelled. Seniors and other vulnerable populations who are limiting their time spent in public spaces may no longer have easy access to drug disposal kiosks.

This limited access to drug disposal resources occurs as even with the availability of COVID-19 vaccines, Americans are more isolated as places of employment, schools, and public venues remain closed or operate at limited capacities. Such social isolation can lead to loneliness, depression, and anxiety, and up to 50 percent of people with mental illnesses also struggle with addiction./ix

According to an April 20, 2020, Harvard Health Blog post, isolation may increase the risk of overdose deaths./x

Despite rebounds in many areas of the economy, unemployment rates are still higher than they were pre-pandemic, a factor which may contribute to a risk for opioid abuse and opioid-related deaths. A study from The National Bureau of Economic Research found that every percentage point increase in a county's unemployment rate drove up emergency department visits by 7 percent and opioid deaths by 3.6 percent./xi

Changing Behavior with Access to Deterra(R)

Multiple, independent studies have demonstrated that providing access to Deterra increases the likelihood that they will properly dispose of their opioid medications. Nearly all Deterra consumers (96 percent) report using the product within four weeks of receipt; nearly half report product use within 24 hours./xii

Highlights of additional research on the effectiveness of Deterra's at-home opioid disposal solution are summarized below.

* A March 2019 JAMA Surgery Research Letter/xiii on a University of Michigan clinical trial/xiv indicates Deterra use is correlated with an 8-times greater likelihood of proper disposal of unused and unwanted drugs as compared to usual care. Results assume proper disposal excludes flushing, sinking, or mixing with an unpalatable substance such as kitty litter and coffee grounds.

* A June 2019 Randomized Clinical Trial published in JAMA Pediatrics indicates Deterra use is correlated with a 43-times greater likelihood of proper disposal of unused and unwanted drugs as compared to usual care. Results assume proper disposal excludes flushing, sinking, or mixing with an unpalatable substance such as kitty litter and coffee grounds.

* A November 2020 abstract approved for presentation at the pandemic-canceled annual meeting of the American Society of Regional Anesthesia and Pain Medicine concluded that prior to intervention 52% of surgery patients did not dispose of their narcotics and after the education and disposal bags were given, this rate increased to 93.5%.

Giving patients who are prescribed opioids access to at-home disposal products like Deterra sets them up for behaviors that reduce the likelihood of misuse. Mandatory prescriber education on co-dispensing these products would ensure these products are readily available to anyone taking a prescription opioid and would give prescribers the opportunity to educate patients on the importance of safe drug disposal.

As the FDA moves forward with potential mandatory education requirements for opioid prescribers, we strongly urge the agency to consider the significant evidence base that points to the need for co-dispensing at-home opioid disposal solutions. We would be pleased to serve as a resource to the agency as you move to implement Section 3032 of the SUPPORT Act and other safe disposal initiatives. Thank you again for the opportunity to provide comments and please do not hesitate to contact me at jsundby@deterrasystem.com if you have any questions.

Sincerely,

Jason Sundby

Chairman and Chief Executive Officer

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Footnotes:

i/ https://www.sbir.gov/sbirsearch/detail/679178

ii/ https://www.sbir.gov/sbirsearch/detail/709797

iii/ https://deterrasystem.com/wp-content/uploads/2018/03/NIDA-Final-Report.pdf

iv/ Id.

v/ https://jamanetwork.com/journals/jamapediatrics/article-abstract/2735686

vi/ https://jamanetwork.com/journals/jamasurgery/article-abstract/2729448

vii/ Effect of an Activated Charcoal Bag on Disposal of Unused Opioids After an Outpatient Surgical Procedure: A Randomized Clinical Trial. JAMA Surg. Published online March 27, 2019. doi:10.1001/jamasurg.2019.0155

viii/ https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2527388

ix/ Ross S, Peselow E. Co-occurring psychotic and addictive disorders: neurobiology and diagnosis. Clin Neuropharmacol

x/ https://www.health.harvard.edu/blog/a-tale-of-two-epidemics-when-covid-19-and-opioid-addiction-collide-2020042019569

xi/ https://www.nber.org/papers/w23192.pdf

xii/ https://deterrasystem.com/wp-content/uploads/2018/03/NIDA-Final-Report.pdf

xiii/ Effect of an Activated Charcoal Bag on Disposal of Unused Opioids After an Outpatient Surgical Procedure: A Randomized Clinical Trial. JAMA Surg. Published online March 27, 2019. doi:10.1001/jamasurg.2019.0155

xiv/ https://clinicaltrials.gov/ct2/show/NCT03179566

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The notice can be viewed at: https://www.regulations.gov/document/FDA-2021-N-0951-0001

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