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"Opioid misuse and dependence are reaching epidemic proportions in the United States (US), resulting in overdoses, premature death, infectious disease and economic costs of $56 billion annually (Becker, Sullivan, Tetrault, Desai, & Fiellin, 2008; Birnbaum et al., 2011; Clausen, Waal, Thoresen, & Gossop, 2009; Hser, Hoffman, Grella, & Anglin, 2001; Jones, Mack, & Paulozzi, 2013; Paulozzi, 2012; SAMHSA, 2010; Shah, Lathrop, Reichard, & Landen, 2008; Wisniewski, Purdy, & Blondell, 2008). The problem is increasingly urgent in rural areas which often struggle with high rates of opioid misuse and a lack of available treatment options (Fortney & Booth, 2001; Lenardson & Gale, 2007; Rosenblum et al., 2011; Rounsaville & Kosten, 2000; Sigmon, 2014). "
"With greater access to opioids there has been a parallel rise in reported cases of misuse and abuse of opioid analgesics (Crum, 2006; Compton and Volkow, 2006) and opioid-related overdose fatalities (Jones et al., 2010). In 2012 it was estimated that 4.9 million individuals 12 years or older were current nonmedical users of pain relievers (SAMHSA, NSDUH, 2013), there were 488,004 emergency department visits related to nonmedical use of opioids in 2011 (SAMHSA, DAWN, 2013) and there were l86,986 admissions to treatment facilities for opioid use disorders (SAMHSA, TEDS, 2013). "
"Unfortunately, there is no panacea when it comes to managing pain because patients do not respond similarly to a given medication and may fail to realize the benefits of several formulations due to adverse effects, lack of efficacy due to single nucleotide polymorphism variants   , or the development of tolerance . In spite of the consensus that patients with valid complaints of pain should receive treatment for their pain, there is an equally valid consensus that there is a real and urgent need to decrease the unintended and undesirable consequences that opioid diversion has on society  . Proponents of the new extended-release formulation of hydrocodone argue that there is a real and unmet need for alternate safe and effective options for the management of pain. "
[Show abstract][Hide abstract] ABSTRACT: Recently, the U.S. Food and Drug Administration (FDA) approved Zohydro®, an extended release formulation of the opioid analgesic hydrocodone that contains no acetaminophen. This approval was against the recommendation of the FDA's Expert Panel. Subsequently, both chronic pain advocates and anti-drug abuse advocates have steadfastly expressed their support of, or astonishment at this decision. Here, we review the pharmacokinetics, pharmacodynamics, safety and abuse liability of this hydrocodone formulation and how it relates to Expert Panel's opinion and the FDA decision. We discuss the important issues, risk mitigation, potential use of abuse deterrents, and how the different viewpoints of the Expert Panel and FDA decision makers resulted in the approval and subsequent controversy.
Pharmacological Research 10/2014; 91. DOI:10.1016/j.phrs.2014.09.006 · 3.98 Impact Factor