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USA. FDA approves new dosage strength of buprenorphine and naloxone sublingual film as maintenance treatment for opioid dependence

Agency is taking additional steps to advance the development of new FDA-approved treatments for opioid dependence and encourage their more widespread use. 

The U.S. Food and Drug Administration today approved Cassipa (buprenorphine and naloxone) sublingual film (applied under the tongue) for the maintenance treatment of opioid dependence. This action provides a new dosage strength (16 milligrams/4 milligrams) of buprenorphine and naloxone sublingual film, which is also approved in both brand name and generic versions and in various strengths. (FDA - U.S. Food and Drug Administration, 07.09.2018)

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm619864.htm

USA. OxyContin Billionaire Patents New Drug for Opioid Treatment

In recent years, America’s pharmaceutical industry has taken it on the chin. Populist demagogues have savaged drug companies for “jacking up” the price of life-saving substances like insulin (a.k.a. honoring their fiduciary duty to maximize shareholder value). These boisterous neo-Bolsheviks will point to the fact that pharmaceuticals are several times more expensive in the U.S. than in other countries, and conclude that our government’s exceptionally strong patent laws — and aberrant refusal to push down drug prices through direct negotiation — are meant to enrich Big Pharma at the working American’s expense. (Daily Intelligencer, USA, 07.09.2018)

http://nymag.com/daily/intelligencer/2018/09/richard-sackler-oxycontin-billionaire-patent-opioid-addiction-treatment-buprenorphine.html

Using ecological momentary assessment to examine the relationship between craving and affect with opioid use in a clinical trial of clonidine as an adjunct medication to buprenorphine treatment.

Kowalczyk WJ, Moran LM, Bertz JW, Phillips KA, Ghitza UE, Vahabzadeh M, Lin JL, Epstein DH, Preston KL.

Am J Drug Alcohol Abuse. 2018 Apr 10:1-10. doi: 10.1080/00952990.2018.1454933.

Abstract

https://www.ncbi.nlm.nih.gov/pubmed/29634425

USA. OxyContin maker gets patent for drug to treat opioid addiction

Purdue Pharma, the maker of OxyContin, has received a patent designed to treat opioid addiction.

The patent, first reported by The Financial Times, is for a new and faster-acting form of buprenorphine. (CBS-News, Money Watch, USA, 07.08.2018)

https://www.cbsnews.com/news/oxycontin-maker-receives-patent-for-drug-to-treat-opioid-addiction/

Risky Sexual Behavior among Individuals receiving Buprenorphine/Naloxone Opiate Dependency Treatment: HIV Prevention Trials Network (HPTN) 058.

Shava E, Lipira LE, Beauchamp GG, Donnell DJ, Lockman S, Ruan Y, Shao Y.

J Acquir Immune Defic Syndr. 2018 Mar 19. doi: 10.1097/QAI.0000000000001683.

Abstract/accepted article

https://pdfs.journals.lww.com/jaids/9000/00000/Risky_Sexual_Behavior_among_Individuals_receiving.96712.pdf

The effectiveness of different singly administered high doses of buprenorphine in reducing suicidal ideation in acutely depressed people with co-morbid opiate dependence: a randomized, double-blind, clinical trial.

Ahmadi J, Jahromi MS, Ehsaei Z.

Trials. 2018 Aug 29;19(1):462. doi: 10.1186/s13063-018-2843-9.

https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-2843-9

Does Cannabis Use Influence Opioid Outcomes and Quality of Life Among Buprenorphine Maintained Patients? A Cross-sectional, Comparative Study.

Bagra I, Krishnan V, Rao R, Agrawal A.

J Addict Med. 2018 Mar 14. doi: 10.1097/ADM.0000000000000406.

Abstract

https://www.ncbi.nlm.nih.gov/pubmed/29543612

SAMHSA. Medications for opioid use disorder: for healthcare and addiction professionals, policymakers, patients, and families: Treatment Improvement Protocol: TIP 63.

Substance Abuse and Mental Health Services Administration 
[US] Substance Abuse and Mental Health Services Administration, 2018

https://store.samhsa.gov/shin/content/SMA18-5063FULLDOC/SMA18-5063FULLDOC.pdf

Atomoxetine for amphetamine-type stimulant dependence during buprenorphine treatment: A randomized controlled trial.

Schottenfeld RS, Chawarski MC, Sofuoglu M, Chooi WT, Zaharim NM, M Yasin MA, Ahmad I, Syed Jaapar SZ, Vicknasingam BK.

Drug Alcohol Depend. 2018 Mar 10;186:130-137. doi: 10.1016/j.drugalcdep.2018.01.017.

Abstract

https://www.ncbi.nlm.nih.gov/pubmed/29573648

The Efficacy of Buprenorphine in Major Depression, Treatment-Resistant Depression and Suicidal Behavior: A Systematic Review.

Serafini G, Adavastro G, Canepa G, De Berardis D, Valchera A, Pompili M, Nasrallah H, Amore M.

Int J Mol Sci. 2018 Aug 15;19(8). pii: E2410. doi: 10.3390/ijms19082410. 

http://www.mdpi.com/1422-0067/19/8/2410

Perceptions and practices addressing diversion among US buprenorphine prescribers.

Lin LA, Lofwall MR, Walsh SL, Gordon AJ, Knudsen HK.

Drug Alcohol Depend. 2018 Mar 10;186:147-153. doi: 10.1016/j.drugalcdep.2018.01.015.

Abstract

https://www.ncbi.nlm.nih.gov/pubmed/29573649

Willingness to receive intravenous buprenorphine treatment in opioid-dependent people refractory to oral opioid maintenance treatment: results from a community-based survey in France.

Roux P, Rojas Castro D, Ndiaye K, Briand Madrid L, Laporte V, Mora M, Maradan G, Morel S, Spire B, Carrieri P.

Subst Abuse Treat Prev Policy. 2017 Nov 2;12(1):46. doi: 10.1186/s13011-017-0131-4.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5667450/

Addressing discordant quantitative urine buprenorphine and norbuprenorphine levels: Case examples in opioid use disorder.

Holt SR, Donroe JH, Cavallo DA, Tetrault JM.

Drug Alcohol Depend. 2018 Mar 2;186:171-174. doi: 10.1016/j.drugalcdep.2017.12.040.

Abstract

https://www.ncbi.nlm.nih.gov/pubmed/29579725

USA. FDA Nixes Approval of Buprenorphine Spray for Pain

Today the US Food and Drug Administration (FDA) turned down approval of Buvaya, a buprenorphine sublingual spray (INSYS Therapeutics) for moderate to severe pain resulting from reported safety concerns. (Medscape, 27.07.2018)

https://www.medscape.com/viewarticle/899924

Effectiveness of Tapering from Methadone or Buprenorphine Maintenance Treatment Compared to Traditional Maintenance Treatment for People with Opiate Addiction: Systematic Review [Internet].

Dalsbø TK, Steiro A, Strømme H, Reinar LM.

Oslo, Norway: Knowledge Centre for the Health Services at The Norwegian Institute of Public Health (NIPH); 2017 Mar 2.

https://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0098803/

Buprenorphin-Naloxone: Mundipharma bringt Zubsolv®

Berlin- Die Substitutionstherapie opioidabhängiger Patienten erfolgt durch medizinische, soziale und psychotherapeutische Maßnahmen. Mundipharma bringt mit Zubsolv neue Sublingualtabletten mit Buprenorphin und Naloxon auf den Markt. (apotheke adhoc, 17.05.2018)

https://www.apotheke-adhoc.de/nachrichten/detail/pharmazie/mundipharma-bringt-zubsolv-opioidabhaengigkeit/

Buprenorphine Maintenance Subjects Are Hyperalgesic and Have No Antinociceptive Response to a Very High Morphine Dose.

Athanasos P, Ling W, Bochner F, White JM, Somogyi AA.

Pain Med. 2018 Mar 5. doi: 10.1093/pm/pny025.

Abstract

https://www.ncbi.nlm.nih.gov/pubmed/29514333

Pharmacokinetic and pharmaceutical properties of a novel buprenorphine/naloxone sublingual tablet for opioid substitution therapy versus conventional buprenorphine/naloxone sublingual tablet in healthy volunteers.

Jönsson M, Mundin G, Sumner M.

Eur J Pharm Sci. 2018 Jun 22;122:125-133. doi: 10.1016/j.ejps.2018.06.024.

Abstract 

https://www.sciencedirect.com/science/article/pii/S092809871830280X

Transferring Patients From Methadone to Buprenorphine: The Feasibility and Evaluation of Practice Guidelines.

Lintzeris N, Monds LA, Rivas C, Leung S, Dunlop A, Newcombe D, Walters C, Galea S, White N, Montebello M, Demirkol A, Swanson N, Ali R.

J Addict Med. 2018 Mar 5. doi: 10.1097/ADM.0000000000000396.

Abstract

https://www.ncbi.nlm.nih.gov/pubmed/29509558

Primary Care and the Opioid-Overdose Crisis — Buprenorphine Myths and Realities

Sarah E. Wakeman, M.D., and Michael L. Barnett, M.D.

N Engl J Med 2018; 379:1-4, DOI: 10.1056/NEJMp1802741

https://www.nejm.org/doi/full/10.1056/NEJMp1802741

Umstellung von Methadon / Polamidon auf Buprenorphin – die Ravensburger Strategie

Dr.med. Frank Matschinski; SchwerPunktPraxis Ravensburg, 2013

https://www.forum-substitutionspraxis.de/images/Download/PDF/Umstellung_von_Methadon___Polamidon_auf_Buprenorphin__die_Ravensburger_Strategie.pdf

Buprenorphine - Drugs and Lactation Database

Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006-. Last Revision: June 4, 2018.

https://www.ncbi.nlm.nih.gov/books/NBK501202/

Buprenorphin-Depot: FDA issues complete response letter for CAM2038 for opioid use disorder

Lund, Sweden — 21 January 2018 — Camurus (NASDAQ STO: CAMX) today announced that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the new drug application (NDA) for CAM2038, investigational buprenorphine weekly and monthly depot injections, for the treatment of adults with opioid use disorder (OUD). The FDA has requested additional information to complete the review. There is no need for new clinical studies and the Agency’s requests will be addressed in a timely manner.

“The FDA has issued a complete response letter that will serve as road map for approval and we are confident that the questions raised by the Agency can be effectively managed and resolved”, said Fredrik Tiberg, President & CEO of Camurus. ”Our US partner Braeburn Pharmaceuticals will work closely with the FDA with the goal of bringing CAM2038 to market as quickly as possible.”

CAM2038 has received Fast Track status for treatment of OUD. The NDA was granted FDA Priority Review on 18 September 2017 and FDA Advisory Committee recommended approval on 1 November 2017. If approved, CAM2038 would be the first and only long-acting injectable for individualized treatment of OUD that can be used from start of treatment Day 1 and throughout patients' recovery. (Camurus, Lund/Schweden, 21.01.2018)

http://mb.cision.com/Main/13456/2435148/780076.pdf

Weekly and Monthly Subcutaneous Buprenorphine Depot Formulations vs Daily Sublingual Buprenorphine With Naloxone for Treatment of Opioid Use Disorder: A Randomized Clinical Trial.

Lofwall MR, Walsh SL, Nunes EV, Bailey GL, Sigmon SC, Kampman KM, Frost M, Tiberg F, Linden M, Sheldon B, Oosman S, Peterson S, Chen M, Kim S.

JAMA Intern Med. 2018 May 14. doi: 10.1001/jamainternmed.2018.1052.

Abstract

https://www.ncbi.nlm.nih.gov/pubmed/29799968

Buprenorphine alone or with naloxone: Which is safer?

Kelty E, Cumming C, Troeung L, Hulse G.

J Psychopharmacol. 2018 Feb 1:269881118756015. doi: 10.1177/0269881118756015.

Abstract

http://journals.sagepub.com/doi/abs/10.1177/0269881118756015?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%3dpubmed

Die Umstellung von y-Agonisten auf Buprenorphin

Dr.med.F. Matschinski, Schwerpunktpraxis für Suchtmedizin Ravensburg

Präsentation (Folien) von der DSÄ-Fortbildungsveranstaltung vom 14.04. in Köln-Sürth

https://www.dsae.de/kcfinder/upload/files/praesentationen/Umstellung_auf_Buprenorphin-Matschinski_2018_Koeln.pdf

Conversion of chronic pain patients from full-opioid agonists to sublingual buprenorphine.

Daitch J, Frey ME, Silver D, Mitnick C, Daitch D, Pergolizzi J Jr.

Pain Physician. 2012 Jul;15(3 Suppl):ES59-66.

http://www.painphysicianjournal.com/current/pdf?article=MTcwNg%3D%3D&journal=68

Frontline Science: Buprenorphine decreases CCL2-mediated migration of CD14+ CD16+ monocytes.

Jaureguiberry-Bravo M, Lopez L, Berman JW.

J Leukoc Biol. 2018 May 23. doi: 10.1002/JLB.3HI0118-015R. 

Abstract

https://www.ncbi.nlm.nih.gov/pubmed/29791013

The Pharmacokinetics and Local Tolerability of a Novel Sublingual Formulation of Buprenorphine.

Lim SCB, Schug S, Krishnarajah J.

Pain Med. 2018 Jan 3. doi: 10.1093/pm/pnx321.

Abstract

https://www.ncbi.nlm.nih.gov/pubmed/29309700

USA. San Francisco will bring anti-addiction medication to users on the streets

(...) The city announced Thursday that its medical providers will offer buprenorphine and naltrexone prescriptions at needle exchanges, in parks and in other places where people with opioid disorders congregate. Users will be able to pick up the medications, which block the craving for opioids and the painful symptoms of withdrawal, at a centrally located city-run pharmacy. (Washington Post, 17.05.2018)

https://www.washingtonpost.com/national/health-science/san-francisco-will-bring-anti-addiction-medication-to-users-on-the-streets/2018/05/16/432238ee-593a-11e8-b656-a5f8c2a9295d_story.html

Buprenorphine Formulations: Clinical Best Practice Strategies Recommendations for Perioperative Management of Patients Undergoing Surgical or Interventional Pain Procedures.

Jonan AB, Kaye AD, Urman RD.

Pain Physician. 2018 Jan;21(1):E1-E12.

http://www.painphysicianjournal.com/current/pdf?article=NTAwMQ%3D%3D&journal=109

The OPTIMA study, buprenorphine/naloxone and methadone models of care for the treatment of prescription opioid use disorder: Study design and rationale.

Socias ME, Ahamad K, Le Foll B, Lim R, Bruneau J, Fischer B, Wild TC, Wood E, Jutras-Aswad D.

Contemp Clin Trials. 2018 Apr 5;69:21-27. doi: 10.1016/j.cct.2018.04.001.

Abstract

https://www.ncbi.nlm.nih.gov/pubmed/29627621