Iroko Pharmaceuticals announced that the FDA has approved Tivorbex (indomethacin) capsules for the treatment of mild-to-moderate acute pain in adults. Tivorbex was approved at dosage strengths that are 20% lower than the currently available 25mg and 50mg indomethacin products.
The FDA approval was supported by data from two Phase 3 multi-center, placebo-controlled trials that showed significant improvement in pain relief in patients with post-surgical acute pain receiving Tivorbex vs. patients receiving placebo.
Tivorbex contains submicron indomethacin particles that are about 20 times smaller than their original size. Smaller particle size provides an increased surface area, which leads to faster dissolution. Indomethacin is a nonsteroidal anti-inflammatory drug (NSAID) with analgesic and antipyretic properties.
Tivorbex will be available in 20mg and 40mg dosage strength capsules in 30- and 90-count bottles.
For more information call (877) 757-0676 or visit Iroko.com.