P052. Patient's subjective judgement on the ease of use, speed of onset of action, efficacy and tolerability of Diclofenac sodium HPβCD (25 mg/mL) solution for subcutaneous injection vs Diclofenac potassium 50 mg for oral solution for the acute treatment of migraine.

Abstract

Background Several non-steroidal anti-inflammatory drugs (NSAIDs) have been reported to be effective in the management of acute migraine: among them, Diclofenac (DF) is one of the most effective compounds when administered either orally or intramuscularly. DF is a potent NSAID that has been in clinical use for many years, particularly effective for the treatment of inflammatory, degenerative and rheumatic diseases, soft-tissue rheumatism and non-rheumatic painful and inflammatory conditions (post-traumatic, postoperative pain and migraine headache). Among the different forms of administration a novel injectable DF formulation (dissolved in a volume of 1 ml) containing an enhancer of solubility, based idrissipropilbetacyclodextrin (HPbCD) has been recently introduced in Italy. This formulation allows the use into subcutaneous (s.c.) tissue and is characterized by a bioavailability and a safety profile comparable both to the i.m. DF formulation at a dose of 75 mg/3ml (on the market for parenteral treatment) and os DF formulation at a dose of 50 mg. Up to now no study has been performed on DF to assess the point of view of patients in relation to the ease of use of a route of administration with respect to another: this contribution is the first to do so.