What is Effentora?
Effentora is a medicine containing the active substance fentanyl, available as buccal tablets (which dissolve in the mouth), containing 100, 200, 400, 600 or 800 micrograms of fentanyl.
What is Effentora used for?
Effentora is indicated for the treatment of 'breakthrough pain' (transient exacerbations of pain) in adults with cancer who are already on opioid drugs (a group of pain relievers including morphine and fentanyl) for chronic pain due to cancer. Breakthrough pain occurs when the patient complains of additional sudden pain in addition to the underlying pain. despite ongoing treatment with pain medication.
The medicine can only be obtained with a prescription.
How is Effentora used?
Effentora treatment should be initiated and maintained under the guidance of a physician experienced in the treatment of opioid therapy in cancer patients.
Effentora should be taken at the beginning of the painful episode. The tablets should be removed from the packaging and placed immediately in the mouth, above a molar, between the cheek and the gum. The tablet generally dissolves within 14-25 minutes, releasing the active ingredient, which is absorbed directly into the blood. After 30 minutes, any tablet residues can be swallowed with a glass of water. The tablets must not be broken or crushed; they also must not be sucked, chewed or swallowed whole. Patients should not take food or drink while holding the tablet in their mouth.
At the beginning of Effentora therapy, the physician must identify, on a case-by-case basis, the appropriate dose that can provide adequate relief of the patient's pain and, at the same time, reduce unwanted effects. Normally, the starting dose is one 100 microgram tablet, which can be increased until the optimal maintenance dose is reached. The patient should be monitored closely during dose adjustment.
The final dose should not include more than two tablets, but may be revised if the patient has more than four breakthrough pain episodes per day. Doses above 800 micrograms have not been evaluated in clinical studies. It is necessary to wait at least 4 hours before treating another episode of pain.
For more information, see the package leaflet.
How does Effentora work?
The active substance in Effentora, fentanyl, is an opioid (a powerful pain reliever linked to morphine). It is a well-known substance that has been used for many years to control pain. In Effentora, fentanyl is administered through a buccal tablet, whereby it is absorbed through the mucous membrane of the mouth. Once in the blood, fentanyl acts on receptors in the brain and spinal cord, preventing pain.
How has Effentora been studied?
Since fentanyl has been used for many years, the pharmaceutical company presented data from the scientific literature as well as from its own studies.
The effects of Effentora in the treatment of breakthrough pain were investigated in two main studies involving a total of 150 adult cancer patients on opioid therapy. The first study involved 72 patients, the second 78. in both studies, each patient was treated over 10 different painful episodes: in seven of these episodes, Effentora was given, while in the remaining three episodes each patient received a placebo (a dummy treatment). The main measure of effectiveness was the change in pain intensity over the first 30 or 60 minutes after taking the tablet. Each patient scored their pain intensity on an 11-point scale.
What benefit has Effentora shown during the studies?
In both studies Effentora was more effective than placebo in reducing pain. In the first study, pain intensity was reduced by an average of 3.2 points in the 30 minutes after taking Effentora and by 2.0 points after taking placebo. In the second study, there was a reduction in pain intensity by 9.7 points in the 60 minutes after taking Effentora and by 4.9 points with placebo.
What is the risk associated with Effentora?
The most common side effects with Effentora (seen in more than 1 in 10 patients) are a feeling of dizziness or unsteadiness, nausea and reactions at the site of application of the tablet including pain, ulcers, irritation, abnormal sensations, numbness, redness, swelling and blistering Effentora may also cause side effects commonly seen with other opioids, but these tend to diminish or disappear with continued use of the medicine. The most serious adverse reactions are respiratory depression (slowing or stopping of breathing), circulatory depression (reduced heart rate), hypotension (decrease in blood pressure) and shock (insufficient blood supply to tissues). Patients should therefore be monitored to prevent such effects. For the full list of side effects reported with Effentora, see the package leaflet.
Effentora must not be used in people who may be hypersensitive (allergic) to fentanyl or any of the other substances. It should also not be used in patients who are not already taking opioid painkillers as maintenance therapy for pain control, in patients with severe breathing problems or a severe disease causing blockage of the lungs.
Effentora should be used with caution in patients with moderate or severe liver or kidney problems.
Why has Effentora been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Effentora's benefits are greater than its risks for the treatment of breakthrough pain in cancer adults already on opioid maintenance therapy for chronic cancer pain. The committee recommended the granting of a marketing authorization for Effentora.
What measures are being taken to ensure the safe use of Effentora?
The company that makes Effentora will provide educational material to ensure that healthcare professionals are aware of the potential abuse of the medicine. The company will also remind healthcare professionals how to use the medicine safely and disclose the risks of accidental exposure to fentanyl.
Other information about Effentora:
On 4 April 2008, the European Commission granted Cephalon Europe a "Marketing Authorization" for Effentora, valid throughout the European Union.
For the full version of Effentora's EPAR click here.
Last update of this summary: 04-2008.
The information on Effentora - fentanyl published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
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