Iroko announces results from diclofenac Phase 3 study on post-surgical pain

Iroko Pharmaceuticals, LLC today announced Phase 3 study results that showed patients treated with the company's novel, submicron particle, lower-dose diclofenac (18mg and 35mg), a non-steroidal anti-inflammatory drug (NSAID), experienced significant pain relief post surgery compared with placebo>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. These data will be presented on Friday at the 54^th Annual Meeting of the American Headache Society in Los Angeles.    

In the 428 patient, multi-center, randomized, double-blind, active- and placebo-controlled, post-surgical pain model Phase 3 study, both the 18mg and 35mg doses of the novel, submicron particle, 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). The incidence of adverse events was generally comparable across treatment groups; the most common adverse events for all treatment groups were post-procedural swelling, nausea and headache. A single serious adverse event, deep venous thrombosis, was reported in the study for one subject in the celecoxib treatment group.

"These pivotal data indicate that submicron particle diclofenac may provide effective pain relief at a lower dose while offering fast onset of action," stated Stephen Silberstein, Professor of Neurology and Director of the Jefferson Headache Center at Thomas Jefferson University. "In meeting this important study objective, this newly formulated diclofenac could represent a meaningful advance in the management of pain."

"Since existing NSAIDs are often associated with serious dose-related safety concerns, a great need exists for new therapeutics that can provide relief from acute pain and contribute to overall management of pain at lower doses," stated Allan Gibofsky, Professor of Medicine and Public Health at Weill Medical College of Cornell University. "By changing the pharmacokinetic absorption properties of diclofenac through innovative technology, we may now be able to offer patients the possibility of achieving pain relief using lower doses of diclofenac."

"This study represents the first of several late-stage clinical programs we have initiated to address the continuing need in pain management, by using scientific innovation to optimize established therapeutics," said Dr. Clarence Young, Chief Medical Officer of Iroko Pharmaceuticals. "These results further our understanding of the therapeutic potential of submicron particle NSAIDs and provide strong rationale for our extensive research program."