Site-specificity, with state-dependency… the perfect anti-arthritic agent?

UCB (under licence with Almirall Prodesfarma)

Cutting-edge science and differentiation

Aceclofenac is a glycolic acid ester prodrug of diclofenac. Probing the data, McCormack’s methods reveal that contrary to anecdote and expectation, the active drug is not released by hydrolysis within the systemic circulation. Remarkably, the relational outcomes reveal that the drug circulates in the prodrug form and the active form, diclofenac is only released at an inflamed site, such as the arthritic synovium. In support of these new teachings, stratification analysis of phase III data showed that clinical efficacy scores covaried directly with disease severity. By contrast, the comparator drugs showed no relationship between efficacy and disease severity.

Clinical implications of new teachings

These novel findings provided robust evidence in support of new teachings that aceclofenac fulfills criteria as a site-specific and state-dependent anti-rheumatic drug. Although these new teachings were developed as a marketing strategy by UCB, it was not pursued in the longer term by the licensor, Almirall Prodesfarma.

Today, real-world evidence could be anticipated to show the benefits and value of aceclofenac’s probable site-specific and state-dependent properties.

Elderly man in a wheelchair, smiling and holding a nurse's hand
© Shutterstock

Key outcomes

  • Expansion of use within an approved indication

Formal presentations of new teachings by Keith McCormack

  • In Search of the perfect NSAID: Site-specificity remains the challenge, not COX selectivity; Satellite symposium: Pain in Inflammatory Processes: From Science to Daily Practice, 22nd June 2000; EULAR 2000, Annual European Congress of Rheumatology, Nice, France, 21st-24th June 2000.