User:Oceanflynn/sandbox/Vivitrol webliography

This is a draft used as a sandbox work area for potential use in the article on vivitrol. As I am editing and working with content now in the article I have S it to comply by copyright concerns.

Naltrexone is a medication that stops the activity of opioids. It is primarily used in the management of alcohol dependence and opioid dependence.

The closely related medication, methylnaltrexone, is used to treat opioid-induced constipation but does not treat addiction as it does not cross the blood brain barrier. Nalmefene is similar to naltrexone and is used for the same purposes as naltrexone. Naltrexone should not be confused with naloxone, which is used in emergency cases of opioid overdose.

Naltrexone is marketed under the trade name Revia and Vivitrol. In the United States as of 2016, naltrexone tablets cost about $0.91 per day. The extended-release injections cost about $1248.50 USD per month (41.62 USD per day). A combination of naltrexone with bupropion is used to treat obesity in the United States.

Alcoholism
The main use of naltrexone is for the treatment of alcoholism. Naltrexone was shown to decrease the amount and frequency of drinking according to a 2005 article in the Cochrane Database of Systematic Reviews. According to a literature review naltrexone "appear[ed] to be an effective and safe strategy in alcoholism treatment. Even though the sizes of treatment effects might appear moderate in their magnitudes, these should be valued against the background of the relapsing nature of alcoholism and the limited therapeutic options currently available for its treatment." It does not appear to change the percentage of people drinking. Its overall benefit has been described as "modest".

According to a 2012 National Institutes of Health (NIH) "meta-analysis of naltrexone and acamprosate", acamprosate was found to be "slightly more efficacious in promoting abstinence" while naltrexone was found to be "slightly more efficacious in reducing heavy drinking and craving".

According to an 2001 article by Finland-based David Sinclair, MD described a method to stop or reduce alcohol consumption, commercially known as the 'Sinclair Method'. Using this method, naltrexone is "given in a way that allowed 'pharmacological extinction'" by "repeatedly administering [the opioid naltrexone] to a subject suffering from alcoholism" and "having the subject drink an alcoholic beverage" while naltrexone is active as the oioid blocks blocks the positive reinforcement effects of alcohol. In an article published on July 13, 2013 in Psychology Today by Kenneth Anderson, the founder of Harm Reduction for Alcohol, claimed an "80% cure rate for Alcohol Dependence when naltrexone is prescribed according to 'Sinclair Method'.

Opioid use
Naltrexone helps patients overcome opioid addiction by blocking the effects of opioid drugs. It has little effect on opioid cravings. Naltrexone has in general been better studied for alcoholism than for opioids. It is more frequently used for alcoholism, despite its original approval by the FDA in 1984 for opioid addiction.

A 2011 review of studies suggested that naltrexone, when taken by mouth, was not superior to placebo or to no medication, nor was it superior to benzodiazepine or buprenorphine. Because of the poor quality of the reviewed studies, the authors found insufficient evidence to support naltrexone therapy when taken by mouth for an opioid use disorder. While some patients do well with the oral formulation, it must be taken daily, and a patient whose cravings become overwhelming can obtain opioid intoxication simply by skipping a dose. Due to this issue, the usefulness of oral naltrexone in opioid use disorders is limited by the low retention in treatment. Oral naltrexone remains an ideal treatment only for a small part of the opioid-addicted population, usually those with a stable social situation and motivation. With additional contingency management support, naltrexone is effective in a broader population.

Extended-release depot injections of naltrexone, administered once per month, have proven somewhat effective in treating opioid abuse, an approach that avoids the compliance issue that arises with oral formulations.

Formulations
Vivitrol, a naltrexone formulation for depot injection, was approved by the FDA on April 13, 2006, for the treatment of alcohol dependence.

Additionally, naltrexone implants that are surgically implanted are available, although they are authorized for export only (i.e. not for use within Australia). By 2009, Naltrexone implants Australia studies showed encouraging results.

FDA approval of Vivitrol 2013
A team of researchers led by Evgeny Krupitsky MD at Bekhterev Research Psychoneurological Institute, St Petersburg State Pavlov Medical University, St Petersburg, Russia, undertook a "double-blind, placebo-controlled, randomised", 24-week trial running "from July 3, 2008 through October 5, 2009" with "250 patients with opioid dependence disorder" at "13 clinical sites in Russia" on the use of injectable naltrexone (XR-NTX) for opioid dependence. The study was funded by the Boston-based biotech Alkermes firm which produces and markets naltrexone in the United States. They published their findings in The Lancet. Krupitsky et al concluded that XR-NTX represented a "new treatment option...distinct from opioid agonist maintenance treatment". They claimed that "XR-NTX in conjunction with psychosocial treatment might improve acceptance of opioid dependence pharmacotherapy and provide a useful treatment option for many patients". Based on this single study, the FDA authorized use of injectable naltrexone (Vivitrol) for opioid addiction in the United States. Several articles in The Lancet criticized both the Krupitsky study and the FDA decision. Krupitsky study's was run out of Russia, a country where opioid agonists such as methadone and buprenorphine are not available. Following the FDA approval, by 2011 injectable extended-release naltrexone Vivitrol (XR-NTX) which is produced and marketed under the name Vivitrol (XR-NTX) by Alkermes, cost "$1,100 a month" even though naltrexone, "a generic", had been "prescribed since the mid-1990s" as a "once-a-day pill" with "an insurance copay averaging $11 a month. An 2011 article by Wolfe et al in The Lancet reported that this single trial of naltrexone was performed not by comparing it to the best available, evidence-based treatment (methadone or buprenorphine) but by comparing it with a placebo. In addition, the study failed to follow up on participants to document post-treatment overdose - a key measure for opioid substitution therapies. A 2011 article by Wolfe et al in The Lancet argued that these factors led to criticism of the study's design and ethics, and, by  extension, of the FDA's approval of injectable naltrexone for opioid addiction based on this study. In May 2017, United States Secretary of Health and Human Services Tom Price, praised [vivitrol] as the future of opioid addiction treatment after visiting the company’s plant in Ohio. His remarks set off sharp criticism with almost 700 experts in the field of substance abuse submitting a letter to Price cautioning him about Vivitrol's "marketing tactics" and warning him that his comment "ignore widely accepted science". The experts pointed out that Vivitrol's competitors, buprenorphine and methadone, are "less expensive", "more widely used" and have been "rigorously studied". Price had claimed that buprenorphine and methadone were "simply substitute"s for "illicit drugs" whereas according to the letter, "the substantial body of research evidence supporting these treatments is summarized in guidance from within your own agency, including the Substance Abuse and Mental Health Services Administration, the US Surgeon General, the National Institute on Drug Abuse, and the Centers for Disease Control and Prevention. To briefly summarize, buprenorphine and methadone have been demonstrated to be highly effective in managing the core symptoms of opioid use disorder, reducing the risk of relapse and fatal overdose, and encouraging long-term recovery." According to a June 11, 2017 The New York Times article, Alkermes "has spent years coaxing, with a deft lobbying strategy that has targeted lawmakers and law enforcement officials. The company has spent millions of dollars on contributions to officials struggling to stem the epidemic of opioid abuse. It has also provided thousands of free doses to encourage the use of Vivitrol in jails and prisons, which have by default become major detox centers".