New guidelines reiterate need for abuse deterrent technologies and call for enabling clinicians to provide comprehensive pain management including appropriate use of opioid medications
ORLANDO, FL / ACCESSWIRE / November 8, 2022 / Nutriband Inc. (NASDAQ:NTRB)(NASDAQ:NTRBW) supports the new United States Centers for Disease Control and Prevention (CDC) clinical practice guideline entitled “CDC Clinical Practice Guideline for Prescribing Opioids for Pain – United States, 2022” published on November 4, 2022.1 These guidelines are an update to the 2016 clinical practice guideline and allows prescribers to implement comprehensive and holistic pain management including responsible opioid use particularly for patients with moderate to severe chronic pain.
The draft updated guidelines were posted for public comment earlier this year and the feedback was overwhelmingly in favor of easing the restrictions on opioid prescribers to allow patients who can benefit from opioids to get the access they need while still employing risk mitigation strategies to reduce the abuse and misuse of opioids. There is consensus from the pain management community that the misapplication of the 2016 guidelines resulted in an environment that has adversely affected patients, prescribers and caregivers who have few options to manage severe or intractable pain and has had minimal impact on opioid abusers as indicated by the continued rise in opioid overdose deaths.
An important change in the new guideline is the removal of the perceived artificial dose threshold in the 2016 guidelines of 90 morphine milligram equivalent (MME) which has often been mistaken for a mandate along with warnings against abrupt opioid dose reduction or tapering.. Such misapplication, including inflexible application of recommended dosage and duration thresholds, contributed to patient harms, including untreated and undertreated pain, rapid opioid tapers and abrupt discontinuations, acute withdrawal symptoms, and psychological distress, in some cases leading to suicidal ideation and behavior.2 This translated into reduced prescribing of opioids for patients who have intractable severe chronic pain and for whom there are limited other options available. The CDC continues to recommend that clinicians should carefully evaluate a decision to increase opioid dosage based on an individualized assessment of the benefits and risks and weighing the potential for an improvement in quality of life. Most importantly, the CDC states that the 2022 Clinical Practice Guideline is not a replacement for clinical judgment or individualized, person-centered care.1
In addition, the new CDC guidelines acknowledge that abuse deterrent technologies can be used as a risk mitigation strategy as they are expected to reduce the risk of abuse, misuse and diversion of opioids. However, currently approved abuse deterrent products do not prevent opioid misuse or overdose through oral intake, the most common route of opioid misuse. Nutriband’s AVERSA™ technology is being developed to prevent the abuse or misuse of opioids from transdermal patches by multiple common routes of abuse including the oral route through the incorporation of a separate taste deterrent layer containing multiple aversive agents that are extremely unpleasant to the abuser.
Nutriband’s lead product under development is AVERSA™ Fentanyl, an abuse deterrent transdermal system based on its proprietary AVERSA abuse deterrent transdermal technology. AVERSA™ Fentanyl is being developed as a combination of Nutriband’s proprietary AVERSA™ abuse deterrent transdermal technology and Kindeva’s FDA-approved transdermal fentanyl patch (fentanyl transdermal system) and was recently estimated to have the potential to reach peak annual US sales of $80M – $200M roughly five years after launch.3 This analysis was conducted prior to the issuance of the new CDC Opioid Prescribing Guidelines.
Importantly, Nutriband’s AVERSA™ technology also has potential to reduce risk of abuse, misuse, diversion or accidental exposure in patient populations warranting opioid therapy but who are specifically excluded from the CDC Opioid Prescribing Guidelines, specifically patients dealing with cancer-related pain, sickle-cell disease or those patients receiving palliative care.
“It is our mission to reduce the risk profile of a portfolio of transdermal pain management products that have abuse potential through the utilization of our AVERSA™ abuse deterrent technology while ensuring the appropriate access of opioids for pain patients who need them,” said Gareth Sheridan, CEO of Nutriband.
Nutriband’s AVERSA™ abuse deterrent 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 such as opioids used to treat moderate to severe chronic pain. The AVERSA™ 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.
1 Dowell D, Ragan KR, Jones CM, Baldwin GT, Chou R. CDC Clinical Practice Guideline for Prescribing Opioids for Pain – United States, 2022. MMWR Recomm Rep 2022;71(No. RR-3):1-95. DOI: http://dx.doi.org/10.15585/mmwr.rr7103a1.
2 Dowell, D, Ragan, KR, Jones, CM, Baldwin, GT, Chou, R. Prescribing Opioids for Pain – The New CDC Clinical Practice Guideline. NEJM November 3, 2022 DOI: https://www.nejm.org/doi/full/10.1056/NEJMp2211040
3 Health Advances market analysis report 2022
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™ abuse deterrence technology. AVERSA™ 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.
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, 2022 and Forms 10-Q, 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.