What is PecFent?
PecFent is a nasal spray containing the active ingredient fentanyl (100 and 400 micrograms per delivery).
PecFent is a "generic hybrid drug", ie it is similar to the "reference medicines" that contain the same active ingredient, differentiating it by the way it is administered: whereas in fact the reference medicines Effentora (oral tablets) and Actiq (tablets) should be taken by mouth, PecFent is given by inhalation.
What is PecFent used for?
PecFent is used to treat breakthrough pain in adult cancer patients (minimum age: 18 years). By "intense episodic pain" we mean those painful episodes that suddenly appear even during therapy with painkillers. PecFent should be used in patients already treated with opioids (a class of painkillers that include morphine and fentanyl) for the control of chronic cancer pain.
The medicine can only be obtained with a special medical prescription: as indeed the
medicinal product can be used improperly or cause dependence, it is subject to more restrictive conditions of use than the norm.
How is PecFent used?
Treatment with PecFent should be initiated and subsequently directed by a physician experienced in the management of opioid treatment in cancer patients. The doctor must bear in mind the risk of a possible improper use of PecFent.
At the beginning of the treatment the doctor must determine which is the minimum dose suitable to obtain a sufficient analgesic effect in the face of minimal side effects. This decision must be taken even if the patient already takes another drug based on fentanyl, given that the same active ingredient can be absorbed by the body at a different speed depending on the medicinal product that contains it. It is always necessary to start with a test dose of 100 micrograms (equivalent to a supply in the nostril).
When increasing the dose the patient should be kept under close observation. The dose should be administered in one or two deliveries of the same concentration. The patient can take up to four daily doses at the painful episodes at least four hours apart. For more information on the use of PecFent, see the summary of product characteristics (also included in the EPAR).
How does PecFent work?
The active substance in PecFent, fentanyl, is a sufficiently known opioid used for many years in pain therapy. A distribution of PecFent in the nose produces the rapid absorption of a dose of fentanyl in the bloodstream through the blood vessels in the nose. Once in the bloodstream, fentanyl acts on brain and spinal cord receptors to relieve pain.
What studies have been carried out on PecFent?
Since this is a generic hybrid, in addition to the results of the studies conducted on its own, the applicant presented data on the reference drugs.
In one main study, PecFent was compared with placebo (a dummy treatment) in 83 adults with opioid-treated cancer. The main efficacy parameter was the change in the severity of pain during the 30 minutes following the treatment. This variation was quantified by the patient himself with a score from 0 to 10.
Another study measured PecFent's acceptability by asking patients to vote in terms of personal satisfaction and simplicity and ease of use of the medicine.
What benefit has PecFent shown during the studies?
PecFent was more effective than placebo in the treatment of intense episodic cancer pain. In one study, the average reduction in pain in the first 30 minutes after use was quantified with a score of 6.6 in patients treated with PecFent compared to 4.5 in patients treated with placebo.
In the other study, the patients said they were "satisfied" or "very satisfied" with the effects of PecFent in about 90% of intense pain episodes.
What are the risks associated with PecFent?
The most common side effects associated with PecFent (ie observed in between 1 and 10 patients in 100) are disorientation, dysgeusia (taste disturbances), dizziness, drowsiness, headache, epistaxis (nosebleed), rhinorrhea (runny nose), nasal disorders, vomiting, nausea, constipation and itching. For the full list of all side effects reported with PecFent, see the Package Leaflet.
PecFent should not be used in patients who may be hypersensitive (allergic) to fentanyl or any of the other ingredients. It should not be used in patients who do not already follow opioid treatment for pain control or in patients with severe respiratory depression (impaired breathing) or severe pulmonary obstruction (ie illnesses that severely impair breathing).
Why has PecFent been approved?
The CHMP noted that there was a need for fast-acting painkillers against breakthrough pain in cancer patients. Based on the available data, the CHMP considered that PecFent's benefits are greater than its risks and therefore recommended that it be given marketing authorization.
More information on PecFent
On August 31, 2010, the European Commission issued a marketing authorization for Archimedes Development Ltd for PecFent, valid throughout the European Union.
The marketing authorization is valid for five years, after which it can be renewed.
The full EPAR version of PecFent can be consulted on the agency's website. For more information on PecFent therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 07-2010.
