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Seeing a full 12-hour dose in moderate to severe chronic pain patients?
OPANA® ER: an extended release pain medication with true 12-hour dosing that lasts
Only OPANA ER, an extended release opioid, has a true matrix for
every-12-hour dosing
- Patented TIMERx-N oral delivery system precisely and predictably controls the release of oxymorphone into the patient’s system for proven every-12-hour dosing1
Pharmacokinetics of OPANA ER (extended release) are linear and dose-proportional*1,2
In a randomized, 3-period, 4-sequence, crossover study in healthy volunteers1
Randomized, 3-period, 4-sequence, crossover study involving 24 healthy volunteers to evaluate pharmacokinetics and dose proportionality of OPANA ER. Each subject received 3 of 4 possible dose strengths (5 mg, 10 mg, 20 mg, and 40 mg) of OPANA ER. The three 8-day administration periods were separated by a 7-day washout. On days 1 and 8, dose administration was to occur after an overnight fast. Subjects continued fasting until 4 hours after dose administration.1
- Steady-state levels are achieved after 3 days of multiple dose administration3
- Under both single-dose and steady-state conditions, dose proportionality has been established for the 5 mg, 10 mg, 20 mg, and 40 mg tablet strengths for both peak plasma levels (Cmax) and extent of absorption (area under the curve [AUC])3
Long half-life of 9.4-11.3 hours3
* The correlation of pharmacokinetic properties to clinical effects has not been established.
TIMERx®-N is a registered trademark of Penwest Pharmaceutical Co.
References
- Adams MP, Ahdieh H. Pharmacokinetics and dose-proportionality of oxymorphone extended release and its metabolites: results of a randomized crossover study. Pharmacotherapy. 2004(4):468-476.
- Data on file, DOF-OP-01, Endo Pharmaceuticals. Chadds Ford, Pa.
- OPANA ER Full Prescribing Information. Chadds Ford, Pa: Endo Pharmaceuticals; 2008.