US-based Iroko Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) to use Tivorbex (indomethacin) capsules, a nonsteroidal anti-inflammatory drug (NSAID), at 20mg and 40mg doses to treat mild to moderate acute pain in adults.
The drug was approved at dosage strengths that are 20% lower than the 25mg and 50mg indomethacin products currently available in the market.
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Approval was based on data from two Phase II multi-centre, placebo-controlled trials that showed significant improvement in pain relief in patients with post-surgical acute pain receiving Tivorbex compared with patients receiving placebo.
Iroko Pharmaceuticals president and CEO John Vavricka said: "Tivorbex is the second NSAID to be approved from Iroko’s lower dose NSAID pipeline that uses proprietary SoluMatrix fine particle technology."
The company said that the drug contains indomethacin as submicron particles that are about 20 times smaller than their original size and the reduction in particle size provides an increased surface area, leading to faster dissolution.
In October 2013, Iroko’s Zorvolex (diclofenac) capsules were approved by FDA for the treatment of mild to moderate acute pain in adults.
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By GlobalDataThe company said that Zorvolex developed using the same SoluMatrix Fine Particle technology is now available at pharmacies in the US.
University of California professor of medicine, rheumatology Roy Altman said: "Based on recommendations from FDA and other professional organisations, physicians look for the lowest dose option that will provide the appropriate amount of relief for patients experiencing acute pain."
According to the systematic reviews of observational studies, serious NSAID adverse such as cardiovascular thrombotic events, myocardial infarction, stroke, gastrointestinal ulcers, gastrointestinal bleeds and renal events such as acute renal failure are related to the dosage.
Iroko Pharmaceuticals chief medical officer Clarence Young said: "When available, Tivorbex will allow healthcare professionals to have a lower dose formulation of this well-established NSAID."
The company said that Tivorbex is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.
