Accelerate the Development of New MAT/MAR Approaches - Revision history

BasilSavitsky: /* Impactful Federal, State, and Local Policies */

2024-07-25T19:10:36Z

Impactful Federal, State, and Local Policies

← Older revision		Revision as of 12:10, 25 July 2024
Line 14:		Line 14:

	'''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>		'''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>

	'''Congress''' has initiated bipartisan and bicameral steps calling for increased access to MAT. <ref>https://www.murkowski.senate.gov/press/release/bipartisan-bicameral-members-of-congress-call-for-increased-access-to-medication-assisted-treatment</ref>

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

BasilSavitsky: /* Relevant Research */

2024-07-25T19:08:51Z

Relevant Research

← Older revision		Revision as of 12:08, 25 July 2024
Line 10:		Line 10:

	'''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>		'''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>

	'''Cost-Benefit Analysis.''' 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 requirement under the belief it was saving money. This study demonstrates that the policy creates significantly greater long-term costs for criminal justice and healthcare systems. It concludes that 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. “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." <ref>https://doi.org/10.7326/M17-0611</ref>

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

BasilSavitsky: /* Key Information */

2024-07-25T19:04:15Z

Key Information

← Older revision		Revision as of 12:04, 25 July 2024
Line 5:		Line 5:
	=Key Information=		=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. <ref>https://www.fda.gov/news-events/press-announcements/fda-takes-new-steps-advance-development-innovative-products-treating-opioid-use-disorder</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>

	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>

	=Relevant Research=		=Relevant Research=

BasilSavitsky: /* Key Information */

2024-07-25T19:04:02Z

Key Information

← Older revision		Revision as of 12:04, 25 July 2024
Line 5:		Line 5:
	=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>		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>		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>

BasilSavitsky: /* Promising Practices */

2024-02-21T19:21:24Z

Promising Practices

← Older revision		Revision as of 12:21, 21 February 2024
Line 29:		Line 29:
	=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.		'''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 =

	----		----

BasilSavitsky: /* Available Tools and Resources */

2024-02-21T19:13:38Z

Available Tools and Resources

← Older revision		Revision as of 12:13, 21 February 2024
Line 23:		Line 23:
	=Available Tools and Resources=		=Available Tools and Resources=

	'''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> ~~and additional resources that~~ 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>		'''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>

	'''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>		'''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>

BasilSavitsky: /* Impactful Federal, State, and Local Policies */

2024-02-21T19:12:00Z

Impactful Federal, State, and Local Policies

← Older revision		Revision as of 12:12, 21 February 2024
Line 21:		Line 21:
	'''Congress''' has initiated bipartisan and bicameral steps calling for increased access to MAT. <ref>https://www.murkowski.senate.gov/press/release/bipartisan-bicameral-members-of-congress-call-for-increased-access-to-medication-assisted-treatment</ref>		'''Congress''' has initiated bipartisan and bicameral steps calling for increased access to MAT. <ref>https://www.murkowski.senate.gov/press/release/bipartisan-bicameral-members-of-congress-call-for-increased-access-to-medication-assisted-treatment</ref>

	=Available Tools and Resources		=Available Tools and Resources=

	'''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> and additional resources that 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>		'''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> and additional resources that 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>

BasilSavitsky: /* Available Tools and Resources */

2024-02-21T19:11:19Z

Available Tools and Resources

← Older revision		Revision as of 12:11, 21 February 2024
Line 21:		Line 21:
	'''Congress''' has initiated bipartisan and bicameral steps calling for increased access to MAT. <ref>https://www.murkowski.senate.gov/press/release/bipartisan-bicameral-members-of-congress-call-for-increased-access-to-medication-assisted-treatment</ref>		'''Congress''' has initiated bipartisan and bicameral steps calling for increased access to MAT. <ref>https://www.murkowski.senate.gov/press/release/bipartisan-bicameral-members-of-congress-call-for-increased-access-to-medication-assisted-treatment</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> and additional resources that 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>~~		'''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>

	~~'''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>

	=Promising Practices=		=Promising Practices=

BasilSavitsky: /* Impactful Federal, State, and Local Policies */

2024-02-21T19:06:51Z

Impactful Federal, State, and Local Policies

← Older revision		Revision as of 12:06, 21 February 2024
Line 20:		Line 20:

	'''Congress''' has initiated bipartisan and bicameral steps calling for increased access to MAT. <ref>https://www.murkowski.senate.gov/press/release/bipartisan-bicameral-members-of-congress-call-for-increased-access-to-medication-assisted-treatment</ref>		'''Congress''' has initiated bipartisan and bicameral steps calling for increased access to MAT. <ref>https://www.murkowski.senate.gov/press/release/bipartisan-bicameral-members-of-congress-call-for-increased-access-to-medication-assisted-treatment</ref>

	~~'''HHS''' provides a website to support responses to the national opioid epidemic which includes an index of funding opportunities. <ref>https://www.hhs.gov/opioids/</ref>~~

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

BasilSavitsky: /* Impactful Federal, State, and Local Policies */

2024-02-21T18:56:07Z

Impactful Federal, State, and Local Policies

← Older revision		Revision as of 11:56, 21 February 2024
Line 21:		Line 21:
	'''Congress''' has initiated bipartisan and bicameral steps calling for increased access to MAT. <ref>https://www.murkowski.senate.gov/press/release/bipartisan-bicameral-members-of-congress-call-for-increased-access-to-medication-assisted-treatment</ref>		'''Congress''' has initiated bipartisan and bicameral steps calling for increased access to MAT. <ref>https://www.murkowski.senate.gov/press/release/bipartisan-bicameral-members-of-congress-call-for-increased-access-to-medication-assisted-treatment</ref>

	'''HHS''' provides a website to support responses to the national opioid epidemic which includes ~~and~~ index of funding opportunities. <https://www.hhs.gov/opioids/</ref>		'''HHS''' provides a website to support responses to the national opioid epidemic which includes an index of funding opportunities. <ref>https://www.hhs.gov/opioids/</ref>

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