Diclofenac Sodium Bolus Injection (Dyloject^TM): A Review in Acute Pain Management

An intravenous bolus formulation of the non-steroidal anti-inflammatory drug diclofenac sodium has been developed using hydroxypropyl-β-cyclodextrin (HPβCD) as a solubility enhancer. HPβCD diclofenac (Dyloject^TM) is available for use in adults in the USA for the management of mild to moderate pain, and as monotherapy or in combination with opioid analgesics for the management of moderate to severe pain. In two multicentre, phase III studies in adults with acute moderate to severe postoperative pain, HPβCD diclofenac significantly reduced pain intensity and the need for rescue medication compared with placebo. In these studies, the tolerability profile of HPβCD diclofenac was generally similar to that of placebo and adverse events were mostly mild to moderate in severity. Constipation, infusion-site pain and dizziness were the most frequently reported adverse reactions occurring numerically more frequently with HPβCD diclofenac than placebo. Therapy with HPβCD diclofenac does not appear to be associated with an increased risk of cardiovascular, renal or bleeding-related adverse events versus placebo. Thus, HPβCD diclofenac extends the treatment options currently available for the management of moderate to severe postoperative pain in adults.