Diclofenac sodium injection (Akis®, Dicloin®) in the management of pain: a guide to its use in the EU

Abstract

A novel formulation of diclofenac sodium suitable for subcutaneous (SC) or intramuscular (IM) injection (Akis®, Dicloin®) has been developed using the complexing agent hydroxypropyl-β-cyclodextrin (HPβCD) as a solubility enhancer. Diclofenac HPβCD is available in several European countries, where it is indicated for use in adults with acute forms of pain, including postoperative pain. In clinical trials, SC or IM diclofenac HPβCD demonstrated analgesic efficacy in moderate to severe acute postoperative pain following dental surgery or minor orthopaedic surgery, and in moderate to severe neuropathic pain. Diclofenac HPβCD was generally well tolerated. Although injection-site reactions were among the most commonly reported adverse events with diclofenac HPβCD, its local tolerability profile was consistently rated as ‘good’ or ‘excellent’ across all studies. SC administration of diclofenac is a valid alternative to IM delivery, with the advantages of easier administration, the availability of additional body sites suitable for injection and the potential for self-administration. Thus, diclofenac HPβCD 25, 50 or 75 mg/mL solution for SC or IM injection extends the treatment options available for use in the management of acute pain in adults.