SKUDEXUM (dexketoprofen/tramadol), fixed NSAID-weak opioid combination

Substantial actual clinical benefit in symptomatic short-term treatment of moderate to severe acute pain but no proven clinical added value compared to the current therapeutic strategy

• SKUDEXUM has Marketing Authorisation in the symptomatic short-term treatment of moderate to severe acute pain in adult patients whose pain is considered to require a combination of tramadol and dexketoprofen.
• Its superiority over the fixed paracetamol + tramadol combination has been demonstrated on the pain relief score over 6 hours post-treatment administration (TOTPAR₆), but the effectiveness was modest and of debatable clinical relevance.
• Concerns remain in respect of the safety of this fixed combination stemming from its ingredients (known adverse effects of tramadol and dexketoprofen) and in respect of the requirements for its prescription and use in routine practice.