Efficacy and Safety of OPANA ER (Oxymorphone Extended Release) for Relief of Moderate to Severe Chronic Low Back Pain in Opioid-Experienced Patients: A 12-Week, Randomized, Double-blind, Placebo-controlled Study

Oxymorphone Insufflation Associated with Acute Sensorineural Hearing Loss: Case Files of the University of Massachusetts Medical Toxicology Fellowship

“…It is available in both immediate-and extended-release oral formulations. Oxymorphone 10 mg has been shown to be equivalent to oxycodone 20 mg and oral morphine sulfate 30 mg in terms of its analgesic effects [37]. Its potency is due to its high lipid solubility, allowing it to reach its maximum plasma concentration in a shorter amount of time [36].…”

Pharmacotherapy for Chronic Low Back Pain

“…It remains to be determined whether after switching from an initial opioid to another, responsiveness to the original opioid will return over time to allow a switch back if tolerance to the second opioid emerges. In both opioid-naïve and -experienced patients, oxymorphone extended release analgesia and functional improvement remained significantly superior to placebo for the entire 12-week treatment period without dose escalation (Hale et al, 2007;Katz et al, 2007). Of patients successfully titrated and randomized to oxymorphone extended release, 69% completed 12 weeks of treatment (Peniston & Gould, 2009).…”

“…Oxymorphone extended release was evaluated in two 12-week randomized controlled trials in opioid-naive and opioid-experienced patients with moderate to severe chronic low back pain (Hale et al, 2007;Katz et al, 2007). Results from these studies demonstrated that use of a flexible, individualized titration schedule will allow the majority (60% in the 2 studies combined) of patients to be titrated to an effective, generally well-tolerated opioid dose (Peniston & Gould, 2009).…”

“Unsettling circularity”: Clinical trial enrichment and the evidentiary politics of chronic pain

“…About 30 per cent improvement has been proposed as the cutoff for a "clinically meaningful" response (Farrar et al, 2001;Younger et al, 2009), although this may vary from trial to trial (Farrar et al, 2001;Hewitt et al, 2011;Arthritis Research UK, 2013). So-called 'nonresponders' may include subjects who experience a lack of efficacy, fail to achieve a stabilized dose, or have too many or too serious adverse events, but patients may also be removed from the trial for protocol violation, withdrawal of consent, or other considerations (Hale et al, 2007;Katz et al, 2007;Hewitt et al, 2011). Although EERW studies provide less information about non-responders, proponents suggest that this shortcoming is outweighed by the benefits of improved assay sensitivity.…”

“…Some researchers have focused on the value of EERW designs for proof-of-concept trials, and suggested that EERW actually more closely resembles clinical practice because in an enriched study one does not continue exposing a patient to a non-tolerated or ineffective therapy, just as a physician does not typically continue prescribing a drug that does not work (Hale et al, 2007;McQuay et al, 2008;Katz, 2009). Indeed, Amery and Dony's 1975 paper suggests that their strategy is "precisely similar" to clinical practice (Amery and Dony, 1975).…”