The US Food and Drug Administration has approved Iroko Pharmaceuticals' Zorvolex for the treatment of mild to moderate acute pain in adults.
Zorvolex (diclofenac) is a non-steroidal anti-inflammatory drug and has been given the thumbs-up at dosages that are 20% lower than currently-available diclofenac. Iroko says the drug was developed to address the FDA’s public health advisory recommending that NSAIDs be used at the lowest effective dose for the shortest duration of time consistent with individual patient treatment goals.
The risk of serious adverse events, including cardiovascular thrombotic events, myocardial infarction, stroke, gastrointestinal ulcers, gastrointestinal bleeds and renal events associated with NSAIDs is higher among patients receiving higher doses. Clarence Young, Iroko's chief medical officer, noted that "by altering the absorption properties of diclofenac using innovative technology, Zorvolex offers patients the prospect of pain relief at lower doses". That technology is licensed from iCeutica.