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- Demonstrated success with an individualized dose
- Continued success with stabilized dose over 12 weeks
- Less rescue medication was used than the allowable maximum
Challenged by titrating your patients to a stable dose?
OPANA® ER: Demonstrated success with an individualized dose
In the 4-week, open-label titration phase in 250 opioid-experienced patients with moderate to severe chronic low back pain, 142 patients stabilized within 4 weeks1
With OPANA ER, 68% of successfully titrated patients stabilized at a mean effective dose of ≤90 mg/day within 3 weeks*2
- Mean stabilized dose of OPANA ER across the entire titration phase was 87.2 mg/day1
Patients were converted at study entry to an approximately equianalgesic dose of OPANA ER. During the 4-week titration phase, patients were then titrated to a stable dose of OPANA ER at
10 mg increments every 12 hours every 3-7 days. At end of titration, patients were randomized to remain on their stable dose of OPANA ER or to receive placebo (n=142).1
10 mg increments every 12 hours every 3-7 days. At end of titration, patients were randomized to remain on their stable dose of OPANA ER or to receive placebo (n=142).1
With OPANA ER, there was a 66% reduction in average pain score (VAS†) during the titration phase1
- Average pain score (VAS) at study entry was 69.5 mm, while being on ≥ 60mg/day morphine equivalents vs 23.9 mm at end of titration phase1
Adverse events were similar to placebo after the titration phase
* Effective dose defined as adequate analgesia (≤40 mm on 100-mm VAS) for 3 of 5 consecutive days while receiving the same dose of OPANA ER and requiring no more than 2 daily doses of rescue medication. A total of 108 patients did not stabilize to an effective dose.1
† Visual analog scale.
Worried about frequent dose escalation?
OPANA ER: Continued success with stabilized dose over 12 weeks
In the 12-week treatment phase in 142 opioid-experienced patients with moderate to severe chronic low back pain1
With OPANA ER, a stabilized dose remained effective for a full 12 weeks in a majority of patients
- 80% of patients reported a decrease, no change, or a minimal increase (≤10 mm) in pain score (VAS) over the 12-week treatment phase3*
- Minimal increase in mean pain score (VAS) from baseline to final visit with OPANA ER:
9 mm vs 32 mm for placebo (P<0.0001)1 - 62% of patients had a ≥50 mm pain score reduction4
A two-phase clinical trial: a 4-week open-label titration phase in 250 opioid-experienced patients with moderate to severe chronic low back pain who were on a stable opioid dose (≥60 mg morphine equivalents) for at least 2 weeks prior to screening, followed by a 12-week, randomized, double-blind, placebo-controlled treatment phase (n=142). Titration phase: patients initiated on every-12-hour dose of OPANA ER approximately equivalent to prestudy opioid dose, titrated at
10 mg increments every 12 hours every 3-7 days to stabilized dose. Supplemental rescue medication during this period: OPANA (oxymorphone hydrochloride) 5 mg every 4-6 hours as needed. Stabilization defined as adequate analgesia (≤40 mm on 100-mm VAS) for 3 of 5 consecutive days on the same OPANA ER dose with ≤2 doses/day of rescue medication. Treatment phase: stabilized patients randomized to their OPANA ER dose or to placebo. Supplemental rescue medication during this period: OPANA 5 mg every 4-6 hours as needed during the first 4 days; then restricted to 2 daily doses (maximum of OPANA 10 mg per day).1
10 mg increments every 12 hours every 3-7 days to stabilized dose. Supplemental rescue medication during this period: OPANA (oxymorphone hydrochloride) 5 mg every 4-6 hours as needed. Stabilization defined as adequate analgesia (≤40 mm on 100-mm VAS) for 3 of 5 consecutive days on the same OPANA ER dose with ≤2 doses/day of rescue medication. Treatment phase: stabilized patients randomized to their OPANA ER dose or to placebo. Supplemental rescue medication during this period: OPANA 5 mg every 4-6 hours as needed during the first 4 days; then restricted to 2 daily doses (maximum of OPANA 10 mg per day).1
Also studied in a trial of similar design in opioid-naïve patients6
Concerned about rescue medication use?
With OPANA ER, less rescue medication was used than the allowable maximum
- Patients were allowed up to 10 mg/day of immediate-release OPANA as supplemental rescue1
– Average use was consistently less (mean 7.5-8.5 mg/day)1
References
- Hale ME, Ahdieh H, Ma T, Rauck R. 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. J Pain. 2007;8(2):175-184.
- Data on file, DOF-OP-06, Endo Pharmaceuticals. Chadds Ford, Pa.
- OPANA ER Full Prescribing Information. Chadds Ford, Pa: Endo Pharmaceuticals; 2008.
- Data on file, DOF-OP-08, Endo Pharmaceuticals. Chadds Ford, Pa.
- Data on file, DOF-OP-03, Endo Pharmaceuticals. Chadds Ford, Pa.
- Katz N, Rauck R, Ahdieh H, et al. A 12-week, randomized, placebo-controlled trial assessing the safety and efficacy of oxymorphone extended release for opioid-naïve patients with chronic low back pain. Cur Med Res Opin. 2007;23(1):117-128.