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PALEXIA LP (tapentadol), opioid analgesic

NEUROLOGY - Update
Opinions on drugs - Posted on Sep 25 2017

Reason for request

Re-assessment of the actual benefit and the improvement in actual benefit

Insufficient clinical benefit in the treatment of severe, chronic non-cancer, non-neuropathic pain in adults that can only be adequately treated with opioid analgesics.

 

  • PALEXIA LP has Marketing Authorisation in the treatment of severe, chronic pain in adults that can only be adequately treated with opioid analgesics.
  • As a reminder, PALEXIA LP received a favorable opinion for reimbursement in the treatment of chronic severecancer pain.Its clinical benefit is low in this indication.
  • In chronic, severe non-cancer, non-neuropathic pain, given the clinically poorly-relevant efficacy demonstrated in studies with many methodological limitations, the potential for abuse and dependence, and the existence of alternatives for pain management, PALEXIA LP has no role in the treatment strategy.

 

 


Clinical Benefit

Insufficient

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