tapentadol prolonged-release tablets (Palexia SR)

following a resubmission

tapentadol prolonged-release tablets (Palexia® SR) is accepted for restricted use within NHS Scotland.

Indication under review: the management of severe chronic pain in adults, which can be adequately managed only with opioid analgesics.

SMC restriction: patients in whom morphine sulphate modified release has failed to provide adequate pain control or is not tolerated.

Results of a meta-analysis of three, 12-week studies suggest that tapentadol prolonged release has improved gastrointestinal tolerability and similar efficacy compared to another long-acting opioid included as an active control.

The manufacturer’s submission related only to the use of tapentadol prolonged release in severe chronic pain.  SMC has not yet received a submission for tapentadol immediate release tablets for the relief of moderate to severe acute pain in adults, which can be adequately managed only with opioid analgesics. Tapentadol immediate release tablets are not recommended for use in NHS Scotland.