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Stephen F Butler, Emily C McNaughton, Ryan A Black, Theresa A Cassidy
OBJECTIVE: Formulating prescription opioids to limit abuse remains a priority. OROS extended-release (ER) hydromorphone HCl (EXALGO) may have lower abuse potential than many other opioid products. Three postmarketing studies of the relative abuse liability of OROS hydromorphone ER were conducted. METHODS: Estimates of abuse, unadjusted, and adjusted for prescription volume, were generated for OROS hydromorphone ER and comparators from Q2 2010 through Q2 2014 for a high-risk, substance abuse treatment population and the general population using poison control center data...
July 2018: Clinical Journal of Pain
Srinivas R Nalamachu, Michael Kutch, Martin E Hale
CONTEXT: The efficacy and tolerability of once-daily hydromorphone extended release (ER) (OROS(®) hydromorphone ER, Exalgo(®), Mallinckrodt Brand Pharmaceuticals, Inc., Hazelwood, MO) in patients with chronic cancer and noncancer pain have been reported in previous studies. OBJECTIVES: The objective of this analysis was to assess the pooled safety data of OROS hydromorphone ER in opioid-tolerant patients with chronic cancer and noncancer pain. METHODS: Safety results were pooled from 11 clinical studies in opioid-tolerant patients: one 12-week, double-blind, placebo-controlled study; three active-controlled studies; and seven uncontrolled studies (durations of three to 52 weeks)...
December 2012: Journal of Pain and Symptom Management
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August 25, 2011: Medical Letter on Drugs and Therapeutics
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