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Clinical Studies: An Effective Post Operative Pain Medication

Effective analgesia for moderate to severe acute pain — proven in the post-operative setting

Opana is an effective post-operative pain medication for patients suffering moderate to severe acute pain.

Significant post-op pain relief following orthopedic surgery

In a double-blind, placebo- and active-controlled, dose-ranging study of 122 patients with acute moderate to severe post-operative pain following orthopedic surgery1,2

  • Efficacy was demonstrated with the 10 and 20 mg dose. While efficacy was demonstrated for the 30 mg dose, there was no evidence of superiority over the 20 mg dose1
  • There was an unacceptably high rate of naloxone use among patients receiving OPANA 30 mg. Therefore, initiation of therapy with OPANA with doses higher than 20 mg in opioid-naïve patients is not recommended1
  • The most common adverse reactions (≥5%) reported at least once by patients treated with OPANA in this trial were nausea, headache, vomiting and dizziness2

Significant post-op pain reduction following abdominal surgery

In a randomized, double-blind, placebo- and active-controlled, parallel-group study in patients with moderate to severe acute post-operative pain following abdominal surgery3

  • Approximately twice as many patients overall discontinued treatment due to lack of efficacy in the placebo group (62.4%) compared with the OPANA 20-mg group (30.9%)3
  • The most common adverse reactions (≥5%) reported at least once by patients treated in either OPANA post-operative pain medication treatment group were nausea, vomiting, pruritus, and headache3

References

  1. OPANA Full Prescribing Information. Chadds Ford, Pa: Endo Pharmaceuticals; 2006.
  2. Gimbel JS, Walker D, Ma T et al. Efficacy and safety of oxymorphone immediate release for the treatment of mild to moderate pain after ambulatory orthopedic surgery: results of a randomized, double-blind, placebo-controlled trial. Arch Phys Med Rehabil. 2005;86:2284-9.
  3. Aqua K, Gimbel JS, Singla N, et al. Efficacy and tolerability of oxymorphone immediate release for acute postoperative pain after abdominal surgery: a randomized, double-blind, active- and placebo-controlled, parallel-group trial. Clinical Therapeutics. 2007;29(6):1000-1012.