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FDA Approves Fine-Particle Diclofenac (Zorvolex) for Acute Pain
The FDA has approved Zorvolex (diclofenac) capsules, a nonsteroidal anti-inflammatory drug (NSAID), for the treatment of mild-to-moderate acute pain in adults. The drug was approved at dosage strengths that are 20% lower than those of currently available diclofenac products.
The agency’s approval was based on data from a phase III randomized study in which patients treated with Zorvolex reported significant pain relief compared with those receiving placebo.
Zorvolex consists of diclofenac as submicron particles that are approximately 20 times smaller than their original size. The reduction in particle size provides an increased surface area, leading to faster dissolution, according to the product’s developer (Iroko Pharmaceuticals).
Zorvolex was developed to address the FDA’s public health advisory recommending that NSAIDs be used at the lowest effective dose for the shortest period consistent with the individual patient’s treatment goals. The risk of serious adverse events, including cardiovascular thrombotic events, myocardial infarction, stroke, gastrointestinal (GI) ulcers, GI bleeds, and renal events, such as acute renal failure, associated with NSAIDs is greater among patients receiving higher doses.
Source: Iroko Pharmaceuticals; October 21, 2013.