Difference between revisions of "Accelerate the Development of New MAT/MAR Approaches"

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=Key Information=
=Key Information=


International addiction experts, published in the Annals of Internal Medicine, consider initial opioid-agonist treatment (OAT), with no duration restrictions, ''the evidence-based standard of care'' for opioid-use disorder. <ref>https://ajp.psychiatryonline.org/doi/10.1176/appi.ajp.2016.16070792</ref>
Use of MAT for opioid dependence relies on prescription drugs, including Buprenorphine, Methadone, and Naltrexone, to stabilize brain chemistry; reduce or block the euphoric effects of opioids; relieve physiological cravings; and normalize body functions. Regular adherence to MAT with Buprenorphine helps patients gain control over their use of opioids, without causing the cycle of highs and lows, intoxication and withdrawal associated with opioid misuse or abuse. <ref>https://www.fda.gov/news-events/press-announcements/fda-takes-new-steps-advance-development-innovative-products-treating-opioid-use-disorder</ref> The FDA has the ability to ''Fast Track'' the development and review of drugs to treat serious conditions and fill an unmet medical need. <ref>https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track</ref> It has been reviewing and encouraging the innovation of the development of other MAT medications beyond the current three FDA-Approved MAT drugs. <ref>https://www.raps.org/news-and-articles/news-articles/2018/4/opioid-epidemic-fda-drafts-guidance-on-developing</ref> In 2018, the FDA issued new recommendations to support further development of medications for MAT. The goal of the new guidelines is to meet individual patient needs on the recovery journey by bringing new medications to the forefront. With the release of the new recommendations there was also draft guidance surrounding clinical trial of sustained-release “depot” Buprenorphine products to help those with opioid use disorder.  Additionally, in 2018 the FDA approved Lucemyra (lofexidine hydrochloride) for the mitigation of withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults. Lucemyra may lessen the severity of withdrawal symptoms and was approved for treatment for up to 14 days. <ref>https://www.fda.gov/news-events/press-announcements/fda-approves-first-non-opioid-treatment-management-opioid-withdrawal-symptoms-adults</ref>
 
 
In California, where more people have been diagnosed with opioid disorder than in any other U.S. state, publicly funded treatment programs require patients to “fail” - twice - at a three-week course of medically supervised withdrawal before they become eligible for OAT. Policymakers likely maintained this medically managed withdrawal requirement under the belief it was saving money. The study demonstrates, however, that the policy creates significantly greater long-term costs for criminal justice and healthcare systems.
The study concludes OAT would have saved as much as $850 million over five years, not including savings to the criminal justice system, and more than $2 billion, including the cost of arrests and prosecutions. Over 10 years, the total savings would rise to $2.87 billion.<ref>https://doi.org/10.7326/M17-0611</ref>
“In order to see overdose deaths come down, we need to make sure people who have opioid addiction are able to access effective treatment more easily than they can access heroin, fentanyl or pain pills."
 
Use of MAT for opioid dependence relies on prescription drugs, including buprenorphine, methadone and naltrexone, to stabilize brain chemistry; reduce or block the euphoric effects of opioids; relieve physiological cravings; and normalize body functions. Regular adherence to MAT with buprenorphine helps patients gain control over their use of opioids, without causing the cycle of highs and lows, intoxication and withdrawal associated with opioid misuse or abuse.<ref>ttps://www.fda.gov/news-events/press-announcements/fda-takes-new-steps-advance-development-innovative-products-treating-opioid-use-disorder</ref>
 
In 2018 the Food and Drug Administration issued new recommendations to support further development of medications for medication-assisted treatments. The goal of the new guidelines is to bring to the forefront new medications for individual patient needs on the recovery journey. With the release of the new recommendations there was also draft guidance surrounding clinical trial of sustained-release “depot” buprenorphine products to help those with opioid use disorder.  Additionally, in 2018 the FDA approved Lucemyra (lofexidine hydrochloride) for the mitigation of withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults. Lucemyra may lessen the severity of withdrawal symptoms and was approved for treatment for up to 14 days.<ref>https://www.fda.gov/news-events/press-announcements/fda-approves-first-non-opioid-treatment-management-opioid-withdrawal-symptoms-adults</ref>
 
The FDA has been reviewing and encouraging the innovation of the development of other MAT medications beyond the current three FDA-Approved MAT drugs– methadone, buprenorphine and naltrexone.<ref>https://www.raps.org/news-and-articles/news-articles/2018/4/opioid-epidemic-fda-drafts-guidance-on-developing</ref> The FDA has the ability to ''Fast Track'' the development and review of drugs to treat serious conditions and fill an unmet medical need.<ref>https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track</ref>


=Relevant Research=
=Relevant Research=
'''Medication development in opioid addiction: Meaningful clinical end points'''<ref>
https://www.science.org/doi/10.1126/scitranslmed.aan2595</ref>


'''Models for Medication-Assisted Treatment for Opioid Use Disorder, Retention and Continuity of Care'''<ref>https://aspe.hhs.gov/reports/models-medication-assisted-treatment-opioid-use-disorder-retention-continuity-care-0</ref>
'''An HHS study''' included a literature review of peer-reviewed literature that addressed retention in SUD treatment, key informant interviews with six subject matter experts, and five case studies of sites or models that show promise for improving retention in treatment. It is titled, "Models for Medication-Assisted Treatment for Opioid Use Disorder, Retention and Continuity of Care." <ref>https://aspe.hhs.gov/reports/models-medication-assisted-treatment-opioid-use-disorder-retention-continuity-care-0</ref>
 
 
In California, where more people have been diagnosed with opioid disorder than in any other U.S. state, publicly funded treatment programs require patients to “fail” - twice - at a three-week course of medically supervised withdrawal before they become eligible for OAT. Policymakers likely maintained this medically managed withdrawal requirement under the belief it was saving money. The study demonstrates, however, that the policy creates significantly greater long-term costs for criminal justice and healthcare systems.
The study concludes OAT would have saved as much as $850 million over five years, not including savings to the criminal justice system, and more than $2 billion, including the cost of arrests and prosecutions. Over 10 years, the total savings would rise to $2.87 billion.<ref>https://doi.org/10.7326/M17-0611</ref>
“In order to see overdose deaths come down, we need to make sure people who have opioid addiction are able to access effective treatment more easily than they can access heroin, fentanyl or pain pills."


=Impactful Federal, State, and Local Policies=
=Impactful Federal, State, and Local Policies=


The Department Health & Human Services provides a help and resources guide for the National Opioid epidemic on their website.<https://www.hhs.gov/opioids/</ref> This includes the ability to browse grant opportunities and find funding opportunities available to help your community. Below are two grants specific to Medication-Assisted Treatment.
'''The FDA''' is reviewing ways to expand MAT. Its Center for Drug Evaluation and Research has published a "Manual of Policies and Procedures" that provides a policy review of the expansion of generic drug applications. <ref>https://www.fda.gov/media/89061/download</ref>
 
'''Medication-Assisted Treatment – Prescription Drug and Opioid Addiction'''<ref>https://www.grants.gov/search-grants.html?cfda=93.430%2093.664%2093.378%2093.687%2093.732%2093.191%2093.732%2093.732%2093.162%2093.928%2093.527%2093.193%2093.933%2093.243%2093.276%2093.788%2093.959%2093.279%2093.273%2093.912%2093.136%2093.421%2093.772%2093.087</ref>
 
'''Provider’s Clinical Support System – Medication Assisted Treatment Grant'''<ref>https://www.grants.gov/search-grants.html?cfda=93.430%2093.664%2093.378%2093.687%2093.732%2093.191%2093.732%2093.732%2093.162%2093.928%2093.527%2093.193%2093.933%2093.243%2093.276%2093.788%2093.959%2093.279%2093.273%2093.912%2093.136%2093.421%2093.772%2093.087</ref>
 
 
The FDA and Congress are reviewing ways to expand Medication-Assisted Treatment.  
*Bipartisan, Bicameral Members of Congress Call for Increased Access to Medication-Assisted Treatment<ref>https://www.murkowski.senate.gov/press/release/bipartisan-bicameral-members-of-congress-call-for-increased-access-to-medication-assisted-treatment</ref>
*FDA Policy to Review the Expansion of generic drug applications<ref>https://www.fda.gov/media/89061/download</ref>


=Available Tools and Resources=
=Available Tools and Resources=


'''Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Treatment Guidance for Industry'''<ref>https://www.fda.gov/media/114948/download</ref>
'''FDA''' has published "Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Treatment Guidance for Industry." <ref>https://www.fda.gov/media/114948/download</ref> Two articles summarize strategies to develop new treatments for opioid use disorder. <ref>https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-new-steps-encourage-more-widespread-innovation-and</ref> <ref>https://www.raps.org/news-and-articles/news-articles/2018/4/opioid-epidemic-fda-drafts-guidance-on-developing</ref>
 
'''U.S. Department of Health & Human Services: Five Point Strategy to Combat the Opioid Crisis'''<ref>https://www.hhs.gov/opioids/</ref>
 
'''Opioid Epidemic: FDA Drafts Guidance on Developing Depot Buprenorphine Products'''<ref>https://www.raps.org/news-and-articles/news-articles/2018/4/opioid-epidemic-fda-drafts-guidance-on-developing</ref>


'''FDA: ''new steps to encourage more widespread innovation and development of new treatments for opioid use disorder'''' April 18 Statement from FDA Commissioner Gottleib.<ref>https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-new-steps-encourage-more-widespread-innovation-and</ref>
'''HHS''' provides a website to support responses to the national opioid epidemic which includes an index of funding opportunities, some of which are directly applicable to MAT. <ref>https://www.hhs.gov/opioids/</ref>


=Promising Practices=
=Promising Practices=


'''The Sinclair Method.''' <ref>https://www.sinclairmethod.org/what-is-the-sinclair-method-2/</ref> has shown significant success in helping people achieve long-lasting success over alcoholism. This approach focuses on retraining the brain to reduce or eliminate the cravings that people have by having them take Naltrexone before drinking so their brain learns that alcohol no longer provides the effect it previously did, and the cravings dissipate. The Sinclair Method has been very effective in helping people recover from alcoholism (with claims up 80% success rates), and it is the standard approach to treating alcoholism in Finland.   More information is needed on whether this approach has been shown to be effective in helping people with Opioid Use Disorder (OUD). The 3-C Foundation<ref>http://www.cthreefoundation.org/home.html</ref> provides resources on this approach for dealing with alcoholism. One topic that needs research but could be very powerful is to use an approach similar to the Sinclair Method that seems to have a high track record of success to help break people's cravings for opioid drugs. Here are some articles on the Sinclair Method as a way to treat alcohol addiction.<ref>https://www.the-sinclair-method.com/</ref>
'''The Sinclair Method.''' has shown significant success in helping people achieve long-lasting success over alcoholism. <ref>https://www.sinclairmethod.org/what-is-the-sinclair-method-2/</ref> This approach focuses on retraining the brain to reduce or eliminate the cravings that people have by having them take Naltrexone before drinking so their brain learns that alcohol no longer provides the effect it previously did, and the cravings dissipate. The Sinclair Method has been effective in helping people recover from alcoholism, with up 80% success rates, and it is the standard approach to treating alcoholism in Finland. The 3-C Foundation provides resources on this approach for dealing with alcoholism. <ref>http://www.cthreefoundation.org/home.html</ref> More research is needed on whether this approach is effective in helping people with opioid use disorder by breaking cravings for opioid drugs.


'''Universities''' and colleges that have centers and professors that focus on research in the area of addiction and treatment include the University of Michigan Addiction Center (UMAC) <ref>[https://medicine.umich.edu/dept/psychiatry/programs/addiction-center</ref> and the University of Virginia Center of Leading Edge Addiction Research. <ref>https://med.virginia.edu/uva-clear/</ref>
'''Universities''' and colleges that have centers with research faculty who focus on addiction and treatment include the University of Michigan Addiction Center (UMAC) <ref>[https://medicine.umich.edu/dept/psychiatry/programs/addiction-center</ref> and the University of Virginia Center of Leading Edge Addiction Research. <ref>https://med.virginia.edu/uva-clear/</ref>


= Sources =
= Sources =


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Latest revision as of 11:10, 25 July 2024

Introductory Paragraph

The role of Medication-Assisted Treatment (MAT) in helping people with substance use disorder is significant. It is logical to think that all the potential options of MAT have not yet been discovered. Rather than just limit our thinking to those that have been discovered and researched, a comprehensive strategy should include efforts to expand innovation to add new MAT options to the toolkit for helping people. FDA is updating the standards and guidelines to speed the development of new practices to the market.[1]

Key Information

Use of MAT for opioid dependence relies on prescription drugs, including Buprenorphine, Methadone, and Naltrexone, to stabilize brain chemistry; reduce or block the euphoric effects of opioids; relieve physiological cravings; and normalize body functions. Regular adherence to MAT with Buprenorphine helps patients gain control over their use of opioids, without causing the cycle of highs and lows, intoxication and withdrawal associated with opioid misuse or abuse. [2] The FDA has the ability to Fast Track the development and review of drugs to treat serious conditions and fill an unmet medical need. [3] It has been reviewing and encouraging the innovation of the development of other MAT medications beyond the current three FDA-Approved MAT drugs. [4] In 2018, the FDA issued new recommendations to support further development of medications for MAT. The goal of the new guidelines is to meet individual patient needs on the recovery journey by bringing new medications to the forefront. With the release of the new recommendations there was also draft guidance surrounding clinical trial of sustained-release “depot” Buprenorphine products to help those with opioid use disorder. Additionally, in 2018 the FDA approved Lucemyra (lofexidine hydrochloride) for the mitigation of withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults. Lucemyra may lessen the severity of withdrawal symptoms and was approved for treatment for up to 14 days. [5]

Relevant Research

An HHS study included a literature review of peer-reviewed literature that addressed retention in SUD treatment, key informant interviews with six subject matter experts, and five case studies of sites or models that show promise for improving retention in treatment. It is titled, "Models for Medication-Assisted Treatment for Opioid Use Disorder, Retention and Continuity of Care." [6]

Impactful Federal, State, and Local Policies

The FDA is reviewing ways to expand MAT. Its Center for Drug Evaluation and Research has published a "Manual of Policies and Procedures" that provides a policy review of the expansion of generic drug applications. [7]

Available Tools and Resources

FDA has published "Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Treatment Guidance for Industry." [8] Two articles summarize strategies to develop new treatments for opioid use disorder. [9] [10]

HHS provides a website to support responses to the national opioid epidemic which includes an index of funding opportunities, some of which are directly applicable to MAT. [11]

Promising Practices

The Sinclair Method. has shown significant success in helping people achieve long-lasting success over alcoholism. [12] This approach focuses on retraining the brain to reduce or eliminate the cravings that people have by having them take Naltrexone before drinking so their brain learns that alcohol no longer provides the effect it previously did, and the cravings dissipate. The Sinclair Method has been effective in helping people recover from alcoholism, with up 80% success rates, and it is the standard approach to treating alcoholism in Finland. The 3-C Foundation provides resources on this approach for dealing with alcoholism. [13] More research is needed on whether this approach is effective in helping people with opioid use disorder by breaking cravings for opioid drugs.

Universities and colleges that have centers with research faculty who focus on addiction and treatment include the University of Michigan Addiction Center (UMAC) [14] and the University of Virginia Center of Leading Edge Addiction Research. [15]

Sources

  1. ↑ https://www.healthaffairs.org/do/10.1377/hblog20180320.58853/full/
  2. ↑ https://www.fda.gov/news-events/press-announcements/fda-takes-new-steps-advance-development-innovative-products-treating-opioid-use-disorder
  3. ↑ https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track
  4. ↑ https://www.raps.org/news-and-articles/news-articles/2018/4/opioid-epidemic-fda-drafts-guidance-on-developing
  5. ↑ https://www.fda.gov/news-events/press-announcements/fda-approves-first-non-opioid-treatment-management-opioid-withdrawal-symptoms-adults
  6. ↑ https://aspe.hhs.gov/reports/models-medication-assisted-treatment-opioid-use-disorder-retention-continuity-care-0
  7. ↑ https://www.fda.gov/media/89061/download
  8. ↑ https://www.fda.gov/media/114948/download
  9. ↑ https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-new-steps-encourage-more-widespread-innovation-and
  10. ↑ https://www.raps.org/news-and-articles/news-articles/2018/4/opioid-epidemic-fda-drafts-guidance-on-developing
  11. ↑ https://www.hhs.gov/opioids/
  12. ↑ https://www.sinclairmethod.org/what-is-the-sinclair-method-2/
  13. ↑ http://www.cthreefoundation.org/home.html
  14. ↑ [https://medicine.umich.edu/dept/psychiatry/programs/addiction-center
  15. ↑ https://med.virginia.edu/uva-clear/
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