Menarini has developed a fixed combination of dexketoprofen trometamol (NSAID-a product of Menarini’s research) and tramadol hydrochloride (centrally analgesic agent ) as oral formulation (tablet) for the treatment of acute pain of moderate to severe intensity, such as post-operative pain (hysterectomy, hip replacement, extraction of third molar, etc.).
Two phase III clinical trials in the indication of post-surgery moderate to severe acute pain, have been completed in 2014 in approximately 1200 patients in about 80 clinical centers located in 14 European and Asian countries.
The studies confirmed that the dexketoprofen trometamol + tramadol hydrochloride combination was able to provide a level of analgesia above the one achievable by each component alone and presented a safety profile consistent with what was previously reported for dexketoprofen trometamol and tramadol hydrochloride when used as single agents.
The combination results in a superior analgesic effect with the reduction of tramadol, and consequently also the side effects related to the treatment.
The rapid onset of the dexketoprofone effects can induce the analgesic action after 5 minutes whereas the tramadol co-administration ensures a longer duration.
To date, coated tables (approved in EU), effervescent tablets and oral granules (EU approval ongoing) are being developed.
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