The US Food and Drug Administration (FDA) has accepted to review Iroko Pharmaceuticals New Drug Application (NDA) for lower dose submicron diclofenac, a non-steroidal anti-inflammatory drug (NSAID), with a proposed indication of treatment of mild to moderate acute pain in adults.
According to the firm, the lower dose submicron diclofenac NDA submission included data from a study conducted on 428 healthy adults in a Phase 3 multi-center, randomized process, in which the individuals developed significant pain following surgery.
Patients treated with lower dose submicron diclofenac (18mg and 35mg) experienced substantial pain relief post surgery compared with placebo (P=0.01 and P<0.001 respectively).
Iroko Pharmaceuticals president and CEO John Vavricka said the FDA's acceptance of firm's first NDA filing for lower dose submicron diclofenac is an important milestone.
"Our goal is to address the significant unmet need in pain management by bringing new options to patients and physicians. We look forward to working closely with the FDA during the review process," Vavricka added.
