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Submicron NSAIDs Reduce Acute and Chronic Pain in Phase III Trials

Data presented at two medical meetings (Apr. 11)

Positive findings have been reported from phase III studies of lower-dose submicron indomethacin (Iroko Pharmaceuticals) in patients with postsurgical pain, and of lower-dose submicron diclofenac (Iroko) in patients with osteoarthritis (OA) pain. Both studies met their primary endpoints of providing significant pain relief compared with placebo.

In the phase III trial of lower-dose submicron indomethacin, the drug provided significant improvement in pain relief, as measured by a visual analog scale (VASSPID-48), in patients with postsurgical acute pain. The new findings are being presented at the 29th Annual Meeting of the American Academy of Pain Medicine in Ft. Lauderdale, Florida.

In addition, data from the phase III study of lower-dose submicron diclofenac in OA patients showed a significant reduction in pain compared with placebo, as measured by the mean change from baseline in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain subscale at week 12. These findings will be presented at the 2013 World Congress on Osteoarthritis, to be held April 18–21 in Philadelphia, Pennsylvania.

The endomethacin study involved 462 adults with moderate-to-severe pain following bunionectomy surgery. The patients were randomly assigned to receive either lower-dose submicron indomethacin (40 mg three times daily or twice daily, or 20 mg three times daily); celecoxib (Celebrex, Pfizer; 400-mg loading dose followed by 200 mg twice daily); or placebo.

Statistically significant overall decreases in pain intensity were demonstrated for submicron indomethacin 40 mg three times daily (509.6; P < 0.001), 40 mg twice daily (328.0; P = 0.046), and 20 mg three times daily (380.5, P = 0.017) compared with placebo (67.8). There was some evidence of analgesia for celecoxib (279.4), but it did not achieve statistical significance compared with placebo. The most common adverse events across treatment groups included nausea, post-procedural edema, dizziness, and headache.

The diclofenac study involved 305 patients aged 41 to 90 years with OA of the hip or knee. The patients were randomly assigned to receive submicron diclofenac (35 mg three times daily or 35 mg twice daily) or placebo.

Lower-dose submicron diclofenac (35 mg) administered three times daily met the study’s primary endpoint of a significant reduction in pain, as measured by WOMAC. Patients receiving submicron diclofenac experienced a mean reduction in the WOMAC pain subscale score at 12 weeks versus baseline that was 11.6 points greater than the pain reduction in patients receiving placebo (44.1 vs. 32.5, respectively; P = 0.0024). The most common adverse events across treatment groups included diarrhea, headache, nausea, and upper respiratory tract infection.

In March, the FDA accepted for review a new drug application (NDA) for lower-dose submicron diclofenac for the treatment of mild-to-moderate acute pain in adults.

Source: Iroko Pharmaceuticals; April 12, 2013.

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