Human medicines European public assessment report (EPAR): PecFent, fentanyl, Date of authorisation: 31/08/2010, Revision: 26, Status: Authorised

• Application under evaluation
• CHMP opinion
• European Commission decision

Overview

PecFent is a medicine used to treat breakthrough pain in adult patients with cancer. Breakthrough pain is when a patient experiences additional, sudden pain in spite of ongoing treatment with painkillers.

PecFent is used in patients who are already using opioids (a group of painkillers that includes morphine and fentanyl) to control long-term cancer pain.

PecFent is a ‘hybrid medicine’. This means that it is similar to ‘reference medicines’ containing the same active substance, but given in a different way. While the reference medicines Effentora (buccal tablets) and Actiq (lozenges) are taken by mouth, PecFent is given as a spray into the nose.

PecFent contains the active substance fentanyl.

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How is PecFent used?

PecFent is available as a nasal spray (100 and 400 micrograms per spray) and can only be obtained by ‘special’ prescription. This means that because the medicine can be misused or cause addiction, it is used under stricter conditions than normal. Treatment with PecFent should be started by and remain under the supervision of a doctor who has experience in managing opioid treatment in cancer patients. The doctor should keep in mind the potential for PecFent to be abused.

When a patient starts to take PecFent the doctor will need to work out the appropriate dose that will provide adequate pain relief with as few side effects as possible. The first trial dose should always be 100 micrograms (one spray into one nostril). The patient should be monitored carefully while the dose is increased.

The doses should be given as either one spray or two sprays of the same strength. Patients should not take more than four doses a day and should leave a gap of at least four hours between treating each episode of pain.

For more information about using PecFent, see the package leaflet or contact your doctor or pharmacist.

How does PecFent work?

The active substance in PecFent, fentanyl, is an opioid. It is a well-known substance, which has been used to control pain for many years. When the patient sprays PecFent into the nose, a dose of fentanyl is rapidly absorbed into the blood stream through the blood vessels in the nose. Once in the bloodstream, fentanyl acts on receptors in the brain and spinal cord to relieve pain.

What benefits of PecFent have been shown in studies?

Because PecFent is a hybrid medicine, the applicant presented data on the reference medicines in addition to results from its own studies.

In one main study, PecFent was shown to be more effective than placebo (a dummy treatment) at treating breakthrough cancer pain in 83 adults who were being treated with opioids. The main measure of effectiveness was the change in the severity of pain measured by the patients ranking their pain on a scale from 0 to 10. The average reduction in pain during the first 30 minutes after use was 6.6 points in patients receiving PecFent compared with 4.5 in those receiving placebo.

An additional study measured the ‘acceptability’ of PecFent by the patients, rating how satisfied they were with PecFent, and how easy and convenient they found it to use. In this study, patients reported that they were ‘satisfied’ or ‘very satisfied’ with PecFent treatment for around 90% of breakthrough pain episodes.

What are the risks associated with PecFent?

Typical opioid side effects are to be expected with PecFent; often these will stop or become less intense with continued use of the medicine. The most serious of these side effects are respiratory depression (inhibition of breathing), circulatory depression (slow heartbeat), hypotension (low blood pressure) and shock (a steep fall in blood pressure). Patients should be closely monitored for these side effects. For the full list of side effects reported with PecFent, see the package leaflet.

PecFent must not be used in patients who are not already taking opioids to maintain pain control, who have severe respiratory depression (inhibition of breathing) or who have severe obstructive lung conditions (diseases that severely impede breathing). It must not be used to treat short-term pain other than breakthrough pain. For the full list of restrictions, see the package leaflet.

Why is PecFent authorised in the EU?

The European Medicines Agency noted that there was a need for fast-acting pain medicines for breakthrough pain in patients with cancer. Based on available data, the Agency concluded that PecFent’s benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of PecFent?

The company that markets PecFent will provide educational materials in each EU Member State to make sure that patients, doctors and pharmacists are aware of how PecFent should be used, the risk of accidental exposure to fentanyl and how to dispose of the medicine.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of PecFent have also been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of PecFent are continuously monitored. Side effects reported with PecFent are carefully evaluated and any necessary action taken to protect patients.

Other information about PecFent:

PecFent received a marketing authorisation valid throughout the EU on 31 August 2010.

PecFent : EPAR - Summary for the public

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PecFent : EPAR - Risk management plan summary

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Product information

PecFent : EPAR - Product information

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Latest procedure affecting product information:

VR/0000331999

26/02/2026

This medicine’s product information is available in all official EU languages. Select 'available languages' to access the language you need.

Product information documents contain:

• summary of product characteristics (annex I);
• manufacturing authorisation holder responsible for batch release (annex IIA);
• conditions of the marketing authorisation (annex IIB);
• labelling (annex IIIA);
• package leaflet (annex IIIB).

PecFent : EPAR - All Authorised presentations

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PecFent : EPAR - Conditions imposed on member states for safe and effective use - Annex IV

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Product details

Name of medicine

PecFent

Active substance

fentanyl

International non-proprietary name (INN) or common name

fentanyl

Therapeutic area (MeSH)

• Pain
• Cancer

Anatomical therapeutic chemical (ATC) code

N02AB03

Pharmacotherapeutic group

Analgesics

Therapeutic indication

PecFent is indicated for the management of breakthrough pain in adults who are 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 of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equi-analgesic dose of another opioid for a week or longer.

Authorisation details

EMA product number

EMEA/H/C/001164

Marketing authorisation holder

Gruenenthal GmbH

Zieglerstrasse 6 52078 Aachen GERMANY

Marketing authorisation issued

31/08/2010

Revision

26

Assessment history

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Changes since initial authorisation of medicine

PecFent : EPAR - Procedural steps taken and scientific information after authorisation

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15/07/2026

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PecFent : EPAR - Procedural steps taken and scientific information after authorisation (archive)

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First published:

07/01/2011

Last updated:

15/07/2026

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Pecfent-H-C-PSUSA-00001369-202304 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Reference Number:

EMA/57780/2024

English (EN) (130.86 KB - PDF)

First published:

04/04/2024

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PecFent-H-C-PSUSA-00001369-202004: EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Reference Number:

EMA/198076/2021

English (EN) (122.05 KB - PDF)

First published:

14/04/2021

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PecFent-H-C-PSUSA-00001369-201704 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)

Reference Number:

EMA/378606/2018

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First published:

12/06/2018

Last updated:

12/06/2018

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PecFent-H-C-PSUSA-00001369-201404 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Reference Number:

EMA/CHMP/562146/2015

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First published:

20/08/2015

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20/08/2015

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PecFent-H-C-PSUSA-00001369-201304 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

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First published:

14/04/2014

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14/04/2014

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PecFent-H-C-1164-A20-0013 : EPAR - Assessment Report - Article 20

Adopted

Reference Number:

EMA/561822/2012

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First published:

27/11/2012

Last updated:

27/11/2012

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Initial marketing authorisation documents

PecFent : EPAR - Public assessment report

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First published:

14/09/2010

Last updated:

14/09/2010

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CHMP positive summary of opinion for PecFent

Adopted

Reference Number:

EMA/CHMP/344109/2010

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First published:

24/06/2010

Last updated:

24/06/2010

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News on PecFent

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 July 2012

20/07/2012

More information on PecFent

Questions and answers on the review of Conbriza (bazedoxifene), PecFent (fentanyl) and Torisel (temsirolimus)

Reference Number:

EMA/483755/2012

English (EN) (81.95 KB - PDF)

First published:

20/07/2012

Last updated:

20/07/2012

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• Medicines

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