fentanyl (Instanyl)

following an abbreviated submission

fentanyl single dose nasal spray (Instanyl®) is accepted for restricted use in NHS Scotland.

Indication under review: for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain.  Breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain.

Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.

SMC restriction: to patients who are unsuitable for other short-acting oral opioids (e.g. oral morphine) as an alternative to other buccal and sublingual fentanyl preparations.  It should be noted that the doses of fentanyl nasal spray are significantly lower than doses of fentanyl given by other routes of administration for this indication.

In a pharmacokinetic study in healthy volunteers, this single dose fentanyl nasal spray presentation was shown to be bioequivalent to the multi-dose nasal spray presentation and is available at equivalent cost per dose.