PHILADELPHIA — A new nonsteroidal anti-inflammatory drug (NSAID) was recently approved by the Food and Drug Administration for the treatment of mild to moderate pain in adults.
Iroko Pharmaceuticals, LLC, announced that its product Tivorbex was approved in 20 mg and 40 mg strengths. Iroko pointed out that those dosages are 20% lower than the 25 mg and 50 mg indomethacin products currently on the market.
In approving Tivorbex, the FDA considered two Phase 3 multi-center, placebo-controlled trials that demonstrated significant improvement in pain relief in patients with post-surgical acute pain receiving the drug compared with patients receiving placebo, according to the manufacturer.
“The FDA approval of Tivorbex is another significant milestone for Iroko, as it validates our strategic approach toward developing a suite of NSAID products that offer pain management at lower doses,” said John Vavricka, president and CEO, of Iroko Pharmaceuticals. “Tivorbex is the second NSAID to be approved from Iroko’s lower dose NSAID pipeline that uses proprietary SoluMatrix Fine Particle Technology.”
Tivorbex contains indomethacin as submicron particles that are approximately 20 times smaller than their original size, which provides an increased surface area and leads to faster dissolution. In October 2013, FDA approved Iroko’s Zorvolex (diclofenac) capsules, also developed using the technology, for the treatment of mild to moderate acute pain in adults.
The drugs carry the standard NSAID warnings on cardiovascular and gastrointestinal events.
Concomitant administration of indomethacin and aspirin or anticoagulants is not generally recommended because the risk of increased GI bleeding is higher than in users of either drug alone.
The most common adverse reactions in clinical trials (incidence ≥2%) included: nausea, post-procedural edema, headache, dizziness, vomiting, post-procedural hemorrhage, constipation, pruritus, diarrhea, dyspepsia, post-procedural swelling, presyncope, rash, upper-abdominal pain, somnolence, generalized pruritus, hyperhidrosis, decreased appetite, hot flush and syncope.