FDA Approves Another Lower-Dose NSAID for Moderate Pain Control

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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.

Comments (2)

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  1. LAWRENCE R. SCHACHT, M.D. says:

    OBVIOUSLY, FDA DOES NOT REQUIRE COMPARISON OF NEW TIVORBEX CAPSULE FORMULATION TO TRADITIONAL GENERIC INDOMETHACIN CAPSULES FOR EITHER EFFICACY OR INCIDENCE OF SIDE EFFECTS. TOO BAD, BECAUSE TIVORBEX “SUBMICRON PARTICLES” DELIVERY SYSTEM (STILL DOSED TID) OTHERWISE LACKS ANY PROVABLE BENEFIT OVER VASTLY-CHEAPER GENERIC.
    RESPONSIBLE PHYSICIANS HELP CONTROL MEDICAL CARE COSTS, AND WILL NOT BE DUPED BY IROKO’S ADVERTISING.

  2. Karen O'Kelly, MD says:

    I agree with Dr. Schacht. We are not doing our patients any good by making them choose between an expensive prescription and food. I regularly see patients not refilling medications because they cannot afford $9.00/month copayment per drug. Outside the VA is even worse. I recently had a doctor ( whom I had not told I was a physician) prescribe a medication that is a combination of two readily available and inexpensive OTC drugs! Our patients, who often trust us, rarely question our judgement, unless we won’t prescribe the “latest and greatest” they saw advertised on television. This sort of situation strongly highlights why patient education is at least half of our duty toward them.

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