oxycodone (Oxynorm)

following a full submission

oxycodone hydrochloride 50mg/ml injection (OxyNorm®) is accepted for restricted use  within NHS Scotland.

Indication under review: treatment of moderate to severe pain in patients with cancer.

SMC restriction: patients who have difficulty in tolerating morphine or diamorphine therapy and who require a high dose of oxycodone delivered via syringe pump which necessitates the daily preparation of an additional syringe pump if oxycodone 10mg/mL is used.

No new clinical or pharmacokinetic evidence has been presented for this higher strength formulation. Comparative evidence of analgesia achieved with parenteral administration is extrapolated from the lower strength 10mg/mL oxycodone formulation compared with morphine 10mg/mL.

The economic case was made only for patients in a hospice or community setting who require a high dose of oxycodone which necessitates the daily preparation of an additional syringe pump.

Care should be taken to minimise any risk of administration error with the introduction of this increased strength formulation.
 
Oxycodone 50mg/mL is also licensed for the treatment of moderate to severe post-operative pain and severe pain requiring the use of strong opioid.  The manufacturer’s submission  related only to use in moderate to severe pain in patients with cancer therefore SMC cannot recommend the use of oxycodone 50mg/mL injection in the treatment of non-cancer pain.