Actiq lozenges are a new fast-acting fentanyl formulation for the treatment of breakthrough pain in cancer patients. Actiq is absorbed across the oral mucosa and has demonstrated the same rapid-acting analgesic effect as intravenously administered morphine. Compared to peroral morphine, Actiq has a significantly quicker onset of action.
Actiq is the only opioid analgesic indicated for the alleviation of breakthrough pain, although other preparations can also be used in many cases – especially if the patient knows from experience when the breakthrough pain occurs. However, if these far less expensive morphine products cannot be used, then Actiq is a rational choice. Hospitalised patients should continue to receive morphine iv.
Because of its high price, Actiq is not a product for which a general reimbursement is granted. Users must either apply for individual reimbursement or – as is more often the case – terminal-patient reimbursement.
Actiq was marketed on 27 May 2002. The preparation contains the well-known opioid fentanyl, which is already available in an extended-release patch. This new formulation is a fast-acting lozenge for oromucosal administration indicated for breakthrough pain in cancer patients already receiving chronic opioid treatment.
Actiq is available in strengths of 200, 400, 600, 800, 1200 and 1600 g. Treatment must be individually titrated in order to find the dose that provides adequate analgesia for the patient. The product features an integral applicator used to move the lozenge about in the mouth so that the greatest possible exposure of the mucosa is achieved. The lozenge is absorbed within 15 minutes, with onset of action after 5-15 minutes. Detailed instructions for dose titration and use can be found in the summary of product characteristics published by the Danish Medicines Agency (Danish only).
Breakthrough pain in cancer patients is typically moderate to severe, unpredictable, sudden-onset and short-term (<30 minutes). Thus the ideal treatment would have a rapid onset of action and a short duration.
Actiq has been compared with both peroral and intravenous morphine therapy.
In the study comparing Actiq with peroral morphine, an individual dose titration was made for each patient (15-60 mg morphine or 200-1600 g fentanyl). The successful dose was then administered in a randomised crossover study with 134 cancer patients suffering from regular flare-ups of breakthrough pain. It is thus impossible to compare doses of the different therapies. Actiq had a significantly better analgesic effect than morphine in all clinical pain scores within a period of 15-60 minutes. The percentage of patients who experienced a change in pain intensity of at least 33% after 15 minutes was 42% for Actiq and 32% for morphine (NNT = 10), i.e. ten patients must be treated with Actiq if one patient is to achieve greater efficacy than when using morphine.
The population in the study that compared Actiq with iv morphine comprised 133 patients with severe postoperative pain after abdominal surgery. The patients were randomised to treatment with 200 or 800 g fentanyl or 2 or 10 mg iv morphine. There was no significant difference between the four groups in the sum of differences in pain intensity within 60 minutes or in the time until onset of analgesic action (an average of 4.2 minutes for fentanyl and 5.4 and 3.8 minutes respectively for 2 and 10 mg iv morphine).
Adverse Drug Reactions
The most frequent adverse reactions are known opioid reactions such as headache, somnolence, gastrointestinal discomfort, dizziness, dry mouth, dyspnoea and sweating. There are no data for differences reactions between Actiq and morphine as regards adverse reactions.
The same as for fentanyl and other opioids.
Actiq costs 30-90 times more than other relevant peroral PRN therapy (see price table below). Based on the above-mentioned study results, the cost-efficacy ratio for Actiq versus peroral morphine is roughly DKK 1000 per treatment of breakthrough pain.
||Cost per dose (DKK)|
||ketobemidone+ a spasmolytic
|Morphine solution for injection
General reimbursement is not granted for this product; however, terminal patients eligible under section 7c of the Danish Health Security Act will be reimbursed 100%.
Additional information is available from the summary of product characteristics published by the Danish Medicines Agency (Danish only).
Last modified: May 27th 2002