Iroko Pharmaceuticals announced that the FDA has approved Zorvolex (diclofenac) capsules for the treatment of mild-to-moderate acute pain in adults.

Zorvolex is manufactured using SoluMatrix Fine Particle Technology, and has been approved at dosage strengths 20% lower than diclofenac products that are currently available. 

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The reduction in particle size allows for faster dissolution of drug, while at the same time reducing systemic exposure and possibly dose-related side effects. Its mechanism of action may involve inhibition of the cyclooxygenase (COX-1 and COX-2) pathways and prostaglandin synthetase.

The approval of Zorvolex was based on data from a Phase 3 multi-center, randomized study conducted in 428 otherwise healthy adults who developed significant pain following surgery. Patients treated with lower dose submicron diclofenac (18mg and 35mg) experienced significant pain relief post surgery compared with placebo (P=0.01 and P<0.001 respectively).

Zorvolex will be available in 18mg and 35mg strength capsules in 30- and 90-count bottles.

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