Article

Induction of Opioid-Dependent Individuals Onto Buprenorphine and Buprenorphine/Naloxone Soluble-Films

Department of Psychiatry and Behavioral Sciences, Johns Hopkins School of Medicine, Baltimore, Maryland, USA.
Clinical Pharmacology &#38 Therapeutics (Impact Factor: 7.39). 03/2011; 89(3):443-9. DOI: 10.1038/clpt.2010.352
Source: PubMed

ABSTRACT A sublingual soluble-film formulation of buprenorphine/naloxone (B/N) has been approved by the US Food and Drug Administration for the treatment of opioid dependency. This preparation provides unit-dose, child-resistant packaging amenable to tracking and accountability, offers more rapid dissolution, and has a potentially preferred taste vs. tablets. This study compared the ability of buprenorphine (B) and B/N films to suppress spontaneous withdrawal in opioid-dependent volunteers. Participants were maintained on morphine and underwent challenge sessions to confirm sensitivity to naloxone-induced opioid withdrawal. Subjects were randomized to receive either B (16 mg, n = 18) or B/N (16/4 mg, n = 16) soluble films for 5 days. The primary outcome measure was the Clinical Opiate Withdrawal Scale (COWS) score. Thirty-four subjects completed induction onto soluble films. There was a significant decrease in COWS scores but no significant differences between the groups. The results support the use of B and B/N soluble films as safe and effective delivery methods for opioid induction.

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    • "Compared to the tablet formulation, the film would be impossible to crush, reconstitute, and inject (Stanos et al., 2012). The sublingual film's unit dose packaging also addressed the increased potential for childhood exposure with the sublingual tablet (Strain et al., 2011). On September 18, 2012, the pharmaceutical manufacturer of Suboxone R in the United States announced that it would discontinue the sublingual tablet and only distribute sublingual film, which resulted in considerable online discussion among individuals who use this medication, including what this change might mean for treatment and self-treatment. "
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    ABSTRACT: Background: Buprenorphine/naloxone is an effective medication used to treat opioid dependence. Patients in treatment and those using it illegally without prescriptions have discussed using buprenorphine/naloxone anonymously on Internet discussion boards. Their beliefs about self-treatment and efforts to self-treat are not well known. Objectives: To identify facilitators of self-treatment by online buprenorphine/naloxone users. Methods: A qualitative, retrospective study of discussion board postings from September 2010 to November 2012 analyzed 121 threads from 13 discussion boards using grounded theory. Results: Facilitators of self-management themes that emerged included: (1) a ready supply of buprenorphine/naloxone from a variety of sources; (2) distrust of buprenorphine prescribers and pharmaceutical companies; (3) the declaration that buprenorphine/naloxone is a "bad-tasting" medicine; (4) the desire to adopt a different delivery method other than sublingually; and (5) a desire to become completely "substance-free." The sublingual film formulation appears to be an important facilitator in self-treatment because it can more easily be apportioned to extend the medication because of limited supply, cost, or to taper. Conclusions/Importance: The findings indicate a range of self-management activities ranging from altering the amount taken to modifying the physical medication composition or changing the administration route; some of these behaviors constitute problematic extra-medical use. Contributors to discussion boards seem to trust each other more than they trust pharmacists and prescribing physicians. The shared knowledge and behaviors of this understudied online community are important to healthcare providers because of the previously unknown precautions and risks taken to self-treat.
    Substance Use &amp Misuse 07/2014; 49(8):1017-1024. DOI:10.3109/10826084.2014.888449 · 1.23 Impact Factor
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    • "The rationale for introducing the buprenorphine–naloxone film is that it would (a) adhere to sublingual mucosa quickly, be less easy to remove and hence require less time for supervised dosing, and (b) have more tamper-proof unit packaging (compared to the tablets) to limit accidental consumption by children (Das and Das, 2004). Strain et al. (2011) demonstrated that 5-days of dosing with 16/4 mg buprenorphine–naloxone film was effective in suppressing withdrawal features in opioid dependent individuals. Single dose studies comparing the kinetics of buprenorphine–naloxone film and buprenorphine–naloxone tablets suggest a higher peak plasma concentration (C max ) and total bioavailability of the buprenorphine in the buprenorphine–naloxone film preparation compared to the buprenorphine–naloxone tablets preparation (Reckitt Benckiser (Australia) Pty and Ltd., 2011), although the clinical significance of this in treatment-maintained populations (e.g., subjective dose effects, ability to 'hold' over 24 h dosing interval) remains unclear. "
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    ABSTRACT: BACKGROUND: Buprenorphine-naloxone sublingual film was introduced in 2011 in Australia as an alternative to tablets. This study compared the two formulations on subjective dose effects and equivalence, trough plasma levels, adverse events, patient satisfaction, supervised dosing time, and impact upon treatment outcomes (substance use, psychosocial function). METHODS: 92 buprenorphine-naloxone tablet patients were recruited to this outpatient multi-site double-blind double-dummy parallel group trial. Patients were randomised to either tablets or film, without dose changes, over a 31 day period. RESULTS: No significant group differences were observed for subjective dose effects, trough plasma buprenorphine or norbuprenorphine levels, adverse events and treatment outcomes. Buprenorphine-naloxone film took significantly less time to dissolve than tablets (173±71 versus 242±141s, p=0.007, F=7.67). CONCLUSIONS: The study demonstrated dose equivalence and comparable clinical outcomes between the buprenorphine-naloxone film and tablet preparations, whilst showing improved dispensing times and patient ratings of satisfaction with the film.
    Drug and alcohol dependence 01/2013; 131(1-2). DOI:10.1016/j.drugalcdep.2012.12.009 · 3.28 Impact Factor
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    • "To counter medication-tampering techniques that may lead to behaviors that are accompanied by such health risks, a great deal of attention is being paid to drug formulation technologies that may deter abuse (Coleman et al., 2005, 2010; Cone, 2006; Hamed and Moe, 2010; Katz et al., 2011). Examples of such opioid formulations are buprenorphine combined with naloxone (Reckitt Benckiser, Suboxone ® ; Johnson et al., 2003; Mendelson and Jones, 2003), now produced in a film (Strain et al., 2011); an extended-release formulation of morphine containing sequestered naltrexone, that will only be released when the granules are crushed (King Pharmaceuticals/Pfizer, Embeda ® ; Johnson and Setnik, 2011; Smith, 2011); a water-insoluble oxycodone extended-release formulation in a gelatin-capsule (Pain Therapeutics and King Pharmaceuticals/Pfizer, Remoxy TM ; Friedmann et al., 2011a,b; Setnik et al., 2011); an oxycodone extended-release formulation with a polymer coating that is difficult to crush and turns into a gel when mixed with water (Purdue Pharma; reformulated OxyContin ® , Mannion, 2008); extended-release tapentadol with a polyethylene oxide matrix (Ortho-McNeil-Janssen Pharmaceuticals , Titusville, NJ, Nucynta ® ER; Tzschentke et al., 2007, 2009) that has been designed to be crush-resistant (INTAC TM , Grünenthal GmbH, Aachen, Germany); and extended release oxymorphone HCl (Endo Pharmaceuticals Inc., Chadds Ford, PA, reformulated Opana ® ) containing the same matrix as the extended-release tapentadol formulation (Nucynta ® ER) described above. It has been hypothesized that these formulations may be most likely to reduce the attractiveness of prescription opioids to abusers who snort, smoke, or inject them (Budman et al., 2009). "
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    ABSTRACT: The extent of prescription opioid abuse has led to the development of formulations that are difficult to crush. The purpose of the present studies was to examine whether experienced prescription opioid abusers (individuals using prescription opioids for non-medical purposes regardless of how they were obtained) were able to prepare a formulation of oxymorphone hydrochloride ER 40mg designed to be crush-resistant (DCR) for intranasal (Study 1) or intravenous abuse (Study 2), utilizing a non-crush-resistant formulation of oxymorphone (40mg; OXM) as a positive control. No drug was administered in these studies. Participants were provided with DCR and OXM tablets in random order and asked to prepare them for abuse with tools/solutions that they had previously requested. The primary outcome for Study 1 was particle size distribution, and the primary outcome for Study 2 was percent yield of active drug in the extracts. Other descriptive variables were examined to better understand potential responses to these formulations. Fewer DCR than OXM particles were smaller than 1.705mm (9.8% vs. 97.7%), and thus appropriate for analyses. Percent yield of active drug in extract was low and did not differ between the two formulations (DCR: 1.95%; OXM: 1.29%). Most participants were not willing to snort (92%) or inject (84%) the tampered products. Participants indicated that they found less relative value in the DCR than the OXM formulation across both studies. These data suggest that the oxymorphone DCR formulations may be a promising technology for reducing opioid abuse.
    Drug and alcohol dependence 06/2012; 126(1-2):206-15. DOI:10.1016/j.drugalcdep.2012.05.013 · 3.28 Impact Factor
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