Phase 3 Study of Submicron Particle, Lower-Dose Diclofenac For Acute Pain

Iroko Pharmaceuticals announced Phase 3 study results that showed patients treated with the company's submicron particle, lower-dose diclofenac (18mg and 35mg) experienced significant pain relief post surgery compared with placebo (P=0.01 and P<0.001, respectively). The pain relief scores seen with submicron particle diclofenac 35mg were numerically higher than those seen with submicron particle diclofenac 18mg and the active control celecoxib.

The study was a multi-center, randomized, double-blind, multiple-dose, parallel-group, active- and placebo-controlled study conducted in 428 otherwise healthy persons who underwent surgery (bunionectomy with placement of metal rods) under regional anesthesia, experiencing a pain intensity rating of ≥40mm on a 100mm visual analog scale (VAS) during the nine-hour period after anesthesia was discontinued. Participants in the study were randomly assigned to receive submicron particle, lower-dose diclofenac (18mg or 35mg three times a day), celecoxib (400mg first loading dose; 200mg twice a day), or placebo. The primary endpoint was the sum of pain intensity differences measured using a visual analog scale at intervals during the first 48 hours after discontinuation of general anesthesia (VASSPID-48).

Both the 18mg and 35mg doses of the novel lower-dose diclofenac met the primary objective of demonstrating significant improvement in pain relief as measured by the combined differences in pain intensity measured at intervals over 48 hours using a visual analog scale (VASSPID-48) in patients with acute pain. Pain relief scores were 524 for submicron particle diclofenac 35mg, 393 for submicron particle diclofenac 18mg, and 390 for celecoxib. Subjects receiving submicron particle diclofenac capsules 35mg achieved pain relief (P=0.009) during the first four hours after initiating oral treatment (TOTPAR-4).

Diclofenac is a non-steroidal anti-inflammatory drug believed to inhibit the production of prostaglandins, reducing inflammation and pain. The submicron particle, lower-dose formulation is being developed using the SoluMatrix technology, which alters the pharmacokinetic absorption properties of diclofenac, enhancing the drug dissolution and absorption.

For more information call (267) 546-3003 or visit www.iroko.com.