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USA. Trump Opioid Plan Writes in Favoritism to Single Company’s Addiction Medication

The White House’s national strategy to combat the opioid crisis, unveiled last week, would expand a particular kind of addiction treatment in federal criminal justice settings: a single drug, manufactured by a single company, with mixed views on the evidence regarding its use.

Federal prisons should “facilitate naltrexone treatment and access to treatment” to inmates as they transition out of incarceration, according to a fact sheet circulated by the administration. A White House spokesman later confirmed to STAT that the document referred specifically to naltrexone in its injectable form.

Only one manufacturer makes a drug fitting that description: Alkermes, a Massachusetts pharmaceutical company that makes Vivitrol, a monthly injectable drug that blocks the effects of opioids and reduces cravings. (ATForum, USA, 06.04.2018)

http://atforum.com/2018/04/trump-opioid-plan-writes-favoritism-single-companys-addiction-medication/

Review of Case Narratives from Fatal Overdoses Associated with Injectable Naltrexone for Opioid Dependence.

Saucier R, Wolfe D, Dasgupta N.

Drug Saf. 2018 Mar 20. doi: 10.1007/s40264-018-0653-3.

Abstract

https://www.ncbi.nlm.nih.gov/pubmed/29560596

Antagonists in the medical management of opioid use disorders: Historical and existing treatment strategies.

Bisaga A, Mannelli P, Sullivan MA, Vosburg SK, Compton P, Woody GE, Kosten TR.

Am J Addict. 2018 Apr;27(3):177-187. doi: 10.1111/ajad.12711. Review.

https://www.ncbi.nlm.nih.gov/pubmed/29596725

Feasibility and safety of extended-release naltrexone treatment of opioid and alcohol use disorder in HIV clinics: a pilot/feasibility randomized trial.

Korthuis PT, Lum PJ, Vergara-Rodriguez P, Ahamad K, Wood E, Kunkel LE, Oden NL, Lindblad R, Sorensen JL, Arenas V, Ha D, Mandler RN, McCarty D; CTN-0055 CHOICES Investigators.

Addiction. 2017 Jun;112(6):1036-1044. doi: 10.1111/add.13753.

https://escholarship.org/uc/item/7wx9p0hz

Extended-release injectable naltrexone for opioid use disorder: A systematic review.

Jarvis BP, Holtyn AF, Subramaniam S, Tompkins DA, Oga EA, Bigelow GE, Silverman K.

Addiction. 2018 Feb 3. doi: 10.1111/add.14180.

Abstract

https://www.ncbi.nlm.nih.gov/pubmed/29396985

Naltrexone for Opioid Use Disorders: A Review.

Source: CADTH Report / Project in Briefs [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2011-.
2017 Aug.

Excerpt: With the potential advantages of XR-NTX compared with oral naltrexone in patients with opioid use disorder, there is a need to determine whether XR-NTX is a viable treatment option. A review of the clinical effectiveness, cost-effectiveness, and guidelines for injectable and oral naltrexone to treat opioid use disorder will help inform decisions regarding treatment options for managing opioid dependence.

https://www.ncbi.nlm.nih.gov/books/NBK481573/

Managing severe pain and abuse potential: the potential impact of a new abuse-deterrent formulation oxycodone/naltrexone extended-release product.

Pergolizzi JV Jr, Taylor R Jr, LeQuang JA, Raffa RB.

J Pain Res. 2018 Feb 8;11:301-311. doi: 10.2147/JPR.S127602.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5810535/

Effects of extended-release naltrexone on the brain response to drug-related stimuli in patients with opioid use disorder.

Shi Z, Wang AL, Jagannathan K, Fairchild VP, O'Brien CP, Childress AR, Langleben DD.

J Psychiatry Neurosci. 2018 Feb 23;43(3):170036. doi: 10.1503/jpn.170036.

Abstract

https://www.ncbi.nlm.nih.gov/pubmed/29485031

Extended-release naltrexone (XR-NTX) for opioid use disorder in clinical practice: Vivitrol's Cost and Treatment Outcomes Registry.

Saxon AJ, Akerman SC, Liu CC, Sullivan MA, Silverman BL, Vocci FJ.

Addiction. 2018 Mar 1. doi: 10.1111/add.14199.

Abstract

https://www.ncbi.nlm.nih.gov/pubmed/29493836

Could Naltrexone Be Used to Treat Pregnant Women with Opioid Addiction?

Of the three medications currently approved to treat opioid addiction, the long-acting antagonist naltrexone, which blocks opioids from attaching to the mu-opioid receptor, is the newest and the least studied. The research gap is closing, however: A recent study published in Lancet found that extended-release naltrexone was equally effective at reducing illicit opioid use as the partial agonist buprenorphine if patients could be successfully initiated on naltrexone. Initiation requires detoxification from opioids first (since naltrexone elicits withdrawal symptoms in opioid-dependent users), which can be an impediment for some patients. Still, this finding pointed to the promise of naltrexone as an effective treatment approach, as well as the need for research on how to overcome the “detox hurdle” when using an antagonist medication to treat opioid use disorder. (NIDA, Nora’s Blog, 22.02.2018)

https://www.drugabuse.gov/about-nida/noras-blog/2018/02/could-naltrexone-be-used-to-treat-pregnant-women-opioid-addiction

USA. SAMHSA publishes guidance on clinical best practices using medication-assisted treatment to combat the opioid epidemic

The Substance Abuse and Mental Health Services Administration (SAMHSA) is publishing guidance today to help broaden healthcare professionals’ understanding of medications that can be used to treat Americans with opioid use disorder (OUD).

“We know that people can and do recover from opioid use disorders when they receive appropriate treatment, and medication-assisted treatment’s success in treating opioid use disorders is well documented,” said Dr. Elinore F. McCance-Katz, Assistant Secretary for Mental Health and Substance Use. “TIP 63 emphasizes that increasing access to medications to treat opioid use disorder will help more people recover, enabling them to improve their health, living full and productive lives.”

The Treatment Improvement Protocol (TIP) 63, “Medications for Opioid Use Disorder,” reviews the use of the three Food and Drug Administration-approved medications to treat opioid use disorders: methadone, naltrexone, and buprenorphine. Mandated by Section 303 of the Comprehensive Addiction and Recovery Act (P.L. 114-198), this TIP provides guidance for healthcare professionals and addiction treatment providers on appropriate prescribing practices for these medications and effective strategies for supporting the patients utilizing medication for the treatment of OUD. TIP 63 also educates patients, families, and the general public about how OUD medications work and the benefits they offer. The Substance Abuse and Mental Health Services Administration (SAMHSA), 15.02.2018)

https://www.samhsa.gov/newsroom/press-announcements/201802150200

USA-SAMHSA. TIP 63: Medications for Opioid Use Disorders – Full Document (Including Executive Summary and Parts 1-5)

This Treatment Improvement Protocol (TIP) reviews the use of the three Food and Drug Administration (FDA)-approved medications used to treat opioid use disorder (OUD)—methadone, naltrexone, and buprenorphine—and the other strategies and services needed to support recovery for people with OUD. (SAMHSA), 2/2018)

https://store.samhsa.gov/product/SMA18-5063FULLDOC

Injectable Extended-Release Naltrexone to Treat Opioid Use Disorder.

Ndegwa S, Pant S, Pohar S, Mierzwinski-Urban M.

CADTH Issues in Emerging Health Technologies. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2016-. 163.

https://www.ncbi.nlm.nih.gov/books/NBK481477/

Nicotine-Use/Smoking Is Associated with the Efficacy of Naltrexone in the Treatment of Alcohol Dependence.

Anton RF, Latham PK, Voronin KE, Randall PK, Book SW, Hoffman M, Schacht JP.

Alcohol Clin Exp Res. 2018 Feb 12. doi: 10.1111/acer.13601.

Abstract

https://www.ncbi.nlm.nih.gov/pubmed/29431852

USA. Vermont Hub-and-Spoke Evaluation: No Opioid Overdoses, and a Sharp Drop—96%—in Opioid Use

The hubs—OTPs—treat patients who have been assessed as needing the OTP level of care. These patients are given methadone, buprenorphine, or naltrexone. Patients in the spokes—physicians’ offices—are given buprenorphine or naltrexone. (ATForum, 12.02.2018)

http://atforum.com/2018/02/vermont-hub-and-spoke-evaluation-no-opioid-overdoses-and-a-sharp-drop-96-in-opioid-use/

Trends in the Use of Methadone, Buprenorphine, and Extended-Release Naltrexone at Substance Abuse Treatment Facilities: 2003-2015 (Update).

Alderks CE.

The CBHSQ Report. Rockville (MD): Substance Abuse and Mental Health Services Administration (US); 2013-.

https://www.ncbi.nlm.nih.gov/books/NBK469748/

Opiatentzug: Naltrexon und Buprenorphin in Studie gleich gut wirksam

New York – Die Opioidkrise, die von der US-Regierung jetzt zu einem nationalen Notstand erklärt wurde, wird die Behandlung Hunderttausender Abhängiger erforderlich machen. Das National Institute on Drug Abuse hat in einer randomisierten klinischen Studie zwei mögliche Therapien prüfen lassen – mit vergleichbaren Ergebnissen, wie die Publikation im Lancet (2017; doi: 10.1016/S0140-6736(17)32812-X) zeigt. (aerzteblatt.de, 17.11.2017)

https://www.aerzteblatt.de/nachrichten/83509/Opiatentzug-Naltrexon-und-Buprenorphin-in-Studie-gleich-gut-wirksam

Comparative effectiveness of extended-release naltrexone versus buprenorphine-naloxone for opioid relapse prevention (X:BOT): a multicentre, open-label, randomised controlled trial

Lee, Joshua D et al.

The Lancet , Volume 0 , Issue 0 , Published: 14 November 2017, doi.org/10.1016/S0140-6736(17)32812-X

Abstract

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)32812-X/fulltext

Trends in the Use of Methadone, Buprenorphine, and Extended-release Naltrexone at Substance Abuse Treatment Facilities: 2003-2015 (Update).

Alderks, C.E.,

Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration, Rockville, MD. The CBHSQ Report: August 22, 2017.

https://www.samhsa.gov/data/sites/default/files/report_3192/ShortReport-3192.pdf

Pharmacologically controlled drinking in the treatment of alcohol dependence or alcohol use disorders: a systematic review with direct and network meta-analyses on nalmefene, naltrexone, acamprosate, baclofen and topiramate

Palpacuer, C., Duprez, R., Huneau, A., Locher, C., Boussageon, R., Laviolle, B., and Naudet, F. (2017).

Addiction, doi: 10.1111/add.13974.

http://onlinelibrary.wiley.com/doi/10.1111/add.13974/full

Naltrexone- or Nalmefene-Related Buprenorphine Withdrawal: Treat it With… More Buprenorphine.

Lescut C, Gaboriau L, Carton L, Rolland B.

J Clin Psychopharmacol. 2017 Aug 10. doi: 10.1097/JCP.0000000000000763.

http://journals.lww.com/psychopharmacology/Citation/publishahead/Naltrexone__or_Nalmefene_Related_Buprenorphine.98850.aspx

Incidence of Cancer and Cancer Related Mortality in Opiate Dependent Patients Treated with Methadone, Buprenorphine or Implant Naltrexone as Compared with Non-Opiate Using Controls
Kelty E., Dobbins T., and Hulse G.

Heroin Addiction and Related Clinical Problems

Vol. 19 • No. N3 • June 2017

http://www.heroinaddictionrelatedclinicalproblems.org/harcp-archives.php?year=2017

Fatal and non-fatal opioid overdose in opioid dependent patients treated with methadone, buprenorphine or implant naltrexone

Kelty, Erin et al.

International Journal of Drug Policy , Volume 46 , 54 - 60

Abstract

http://www.ijdp.org/article/S0955-3959(17)30143-3/fulltext

Fatal and non-fatal opioid overdose in opioid dependent patients treated with methadone, buprenorphine or implant naltrexone

Kelty, Erin et al.

International Journal of Drug Policy , Volume 46 , 54 - 60

Abstract

http://www.ijdp.org/article/S0955-3959(17)30143-3/fulltext

The makers of Vivitrol have mounted an aggressive campaign to push this narrative to the government and law enforcement. (The Fix, 21.07.2017)

https://www.thefix.com/vivitrol-more-effective-suboxone-and-methadone

Naltrexone for extended-release injectable suspension

https://www.vivitrol.com/

The ads have been popping up on billboards, buses and subways and in glossy magazines, with portraits of attractive men and women and a simple question in bold letters: What is Vivitrol?

Five years ago, Vivitrol was a treatment for opioid addiction that was struggling to find a market. Now, its sales and profile are rising fast, thanks to its manufacturers’ shrewd use of political connections, and despite scant science to prove the drug’s efficacy. (New York Times, 11.06.2017)

https://www.nytimes.com/2017/06/11/health/vivitrol-drug-opioid-addiction.html

A Retrospective Cohort Study of Birth Outcomes in Neonates Exposed to Naltrexone in Utero: A Comparison with Methadone-, Buprenorphine- and Non-opioid-Exposed Neonates.

Kelty E, Hulse G.

Drugs. 2017 May 23. doi: 10.1007/s40265-017-0763-8.

Abstract

https://www.ncbi.nlm.nih.gov/pubmed/28536981