The costs of prescription opioid abuse represent a substantial and growing economic burden for the society. The increasing prevalence of abuse suggests an even greater societal burden in the future.

This study determined the associations between opioid abuse, dependence, and poisonings on costs and comorbidities in the Medicaid population. Medicaid patients in the Medicaid Analytic eXtract (MAX) files from 2002 to 2003 with 12 months of continuous eligibility, age >or=12 years, and with an opioid abuse/dependence-related diagnosis, including opioid abuse, dependence, or poisoning, in 2002 (index date) were matched 3:1 to Medicaid patients with no such diagnosis (controls). Medical costs by claim type incurred 12 months post index date were compared as was the prevalence of select comorbidities. The authors conducted a two-step multivariate regression analysis adjusted for patient characteristics that could influence cost outcomes. Opioid abuse/dependence prevalence was 8.7 per 1000 in 2002-2003. A total of 50,162 patients with abuse or dependence-related diagnoses were matched to 150,486 control patients. Total costs were significantly higher for the abuse/dependence patients ($14,537) than matched controls ($8,663) (P < .001). When controlling for baseline characteristics, adjusted costs continued to be higher for abuse/dependence patients ($23,556 versus $8,436; P < .001). A total of 83.7% of abuse/dependence patients and 51.6% of controls had >or=1 of the predefined comorbidities. Other substance abuse (odds ratio [OR] 9.4), hepatitis A, B, or C (OR 8.8), and poisonings (OR 8.5) were highly associated with a diagnoses for opioid abuse or dependence (P < .001). Medicaid opioid abuse/dependence patients had more comorbidities and higher medical costs in 2002-2003 than Medicaid control patients. Successful interventions to prevent opioid abuse and manage comorbidities could help to reduce costs associated with opioid abuse in the Medicaid population.

Objectives: To evaluate potential for and incidence of aberrant drug-related behaviors among patients with chronic, moderate-to-severe pain in a primary care setting and to determine investigator compliance with universal precautions (UP) approach to pain management.Design: Open label, multicenter.Setting: Primary care centers (N = 281) across the United States.Patients: Opioid naïve and opioid experienced with chronic, moderate-to-severe pain (N = 1,487).Interventions: Morphine sulfate extended-release capsules for ≤4 months. Tools comprising UP approach were treatment agreement, card for obtaining/tracking prescriptions, Screener and Opioid Assessment for Patients with Pain®-Revised questionnaire, pill counts, pain-patient follow-up tool, investigator assessment/plan, and urine drug screens (UDSs).Outcome measures: Proportion of patients at low, moderate, and high risk of opioid misuse/abuse based on prespecified criteria and investigator judgment, proportion of patients with aberrant drug-related behaviors, and proportion of investigators compliant with UP approach.Results: Patients were primarily white (87 percent), women (57 percent); mean age, 53 years (range, 21-92 years). At baseline, 47 percent were considered low risk for opioid misuse/abuse, 52 percent moderate, and 1 percent high. UDSs were positive for illicit/nonprescribed drugs in a proportion of patients throughout the study. Overall, 64 percent of investigators were compliant with major components of UP approach in ≥75 percent of their patients. However, there was a tendency for investigators to assign risk levels for opioid misuse/abuse as lower than protocol specified.Conclusions: Most patients in these primary care study centers were categorized as at least moderate risk for opioid misuse/abuse at baseline. Most primary care investigators complied with the UP approach to pain management and risk assessment. The completion of the brief training and clinical use of the tools during the study led to retained behavior change, but there was a tendency for investigators to assign lower risk levels than those that were protocol-specified, suggesting a need for better understanding of factors influencing investigator decisions.

The abuse potential of Remoxy when taken whole or chewed was significantly lower than two comparators with known abuse potential, including oxycodone IR and crushed oxycodone ER, under the fed/fasted conditions tested. Remoxy may be associated with a reduced risk potential for abuse.

Objective: Midazolam nasal spray (MDZ-NS) is indicated for acute treatment of intermittent, stereotypic episodes of frequent seizure activity (ie, seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern, in patients 12 years of age and older with epilepsy. This trial evaluated safety and efficacy of MDZ-NS in patients with epilepsy who were admitted to the epilepsy monitoring unit for seizure characterization/presurgical evaluation. Methods: In this randomized, double-blind, placebo-controlled phase 3 trial (P261-301; NCT01999777), eligible patients with ≥2 seizures in the 6-hour window preceding trial medication administration for whom treatment was appropriate based on investigator's judgment were randomized (1:1) to MDZ-NS 5 mg or placebo. Efficacy outcomes were proportion of patients seizure-free for 6 hours after treatment and time to first seizure within 6 hours. Safety and tolerability outcomes included treatment-emergent adverse events (TEAEs). Results: Sixty-two patients were randomized (MDZ-NS n = 31; placebo n = 31), received trial medication, and completed the trial. A higher proportion of patients on MDZ-NS than placebo were seizure-free for 6 hours following treatment (54.8% vs 38.7%); however, the 16.1% difference was not statistically significant (P = .1972). The Kaplan-Meier curve of time to first seizure showed separation of both groups in favor of MDZ-NS from ~1.5 hours post-dose and throughout the 6-hour Treatment phase. Median time to first seizure was not estimable for MDZ-NS (>50% of patients had no seizure) and 3.9 hours for placebo (P = .1388). TEAEs with MDZ-NS were generally comparable to those with placebo. There were no deaths, serious TEAEs, or discontinuations due to TEAEs. Significance: Although the observed treatment difference may be clinically meaningful, statistical significance was not demonstrated. Results suggest that MDZ-NS 2416 | SPENCER Et al.