PecFent

fentanyl

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This is a summary of the European public assessment report (EPAR) for PecFent. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for PecFent.

What is PecFent?

PecFent is a nasal spray that contains the active substance fentanyl (100 and 400 micrograms per spray).

PecFent is a ‘hybrid generic 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.

What is PecFent used for?

PecFent is used to treat ‘breakthrough’ pain in adult patients (aged 18 years or over) 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.

This medicine 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.

How is PecFent used?

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. This must be done even if the patient has already been taking another medicine containing fentanyl, because fentanyl from different medicines may not absorbed into the blood at the same speed. 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 further information on the use of PecFent, see the summary of product characteristics (also part of the EPAR).

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.

How has PecFent been studied?

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

In one main study, PecFent was compared with placebo (a dummy treatment) in 83 adults with cancer who were being treated with opioids. The main measure of effectiveness was the change in the severity of their pain during the 30 minutes after treatment. The change in pain severity was measured by the patients ranking their pain on a scale from 0 to 10.

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.

What benefit has PecFent shown during the studies?

PecFent was more effective than placebo in treating breakthrough cancer pain. In one study, 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.

In the additional study, patients reported that they were ‘satisfied’ or ‘very satisfied’ with PecFent treatment for around 90% of breakthrough pain episodes.

What is the risk associated with PecFent?

The most common side effects with PecFent (seen in between 1 and 10 patients in 100) are disorientation, dysgeusia (taste disturbances), dizziness, somnolence (sleepiness), headache, epistaxis (nosebleeds), rhinorrhoea (runny nose), nasal (nose) discomfort, vomiting, nausea (feeling sick), constipation and pruritus (itching). For the full list of all 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 has PecFent been approved?

The CHMP noted that there was a need for fast-acting pain medicines for breakthrough pain in patients with cancer. Based on available data, the Committee concluded that PecFent’s benefits are greater than its risks and recommended that it be given marketing authorisation.

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

A risk management plan has been developed to ensure that PecFent is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for PecFent, including the appropriate precautions to be followed by healthcare professionals and patients.

The company that makes PecFent will also provide educational materials in each European Union (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.

Other information about PecFent:

The European Commission granted a marketing authorisation valid throughout the EU for PecFent on 31 August 2010.

For more information about treatment with PecFent, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
PecFent : EPAR - Summary for the public BG = bălgarski 2010-09-14 2014-04-14
PecFent : EPAR - Summary for the public ES = español 2010-09-14 2014-04-14
PecFent : EPAR - Summary for the public CS = čeština 2010-09-14 2014-04-14
PecFent : EPAR - Summary for the public DA = dansk 2010-09-14 2014-04-14
PecFent : EPAR - Summary for the public DE = Deutsch 2010-09-14 2014-04-14
PecFent : EPAR - Summary for the public ET = eesti keel 2010-09-14 2014-04-14
PecFent : EPAR - Summary for the public EL = elliniká 2010-09-14 2014-04-14
PecFent : EPAR - Summary for the public EN = English 2010-09-14 2014-04-14
PecFent : EPAR - Summary for the public FR = français 2010-09-14 2014-04-14
PecFent : EPAR - Summary for the public IT = italiano 2010-09-14 2014-04-14
PecFent : EPAR - Summary for the public LV = latviešu valoda 2010-09-14 2014-04-14
PecFent : EPAR - Summary for the public LT = lietuvių kalba 2010-09-14 2014-04-14
PecFent : EPAR - Summary for the public HU = magyar 2010-09-14 2014-04-14
PecFent : EPAR - Summary for the public MT = Malti 2010-09-14 2014-04-14
PecFent : EPAR - Summary for the public NL = Nederlands 2010-09-14 2014-04-14
PecFent : EPAR - Summary for the public PL = polski 2010-09-14 2014-04-14
PecFent : EPAR - Summary for the public PT = português 2010-09-14 2014-04-14
PecFent : EPAR - Summary for the public RO = română 2010-09-14 2014-04-14
PecFent : EPAR - Summary for the public SK = slovenčina 2010-09-14 2014-04-14
PecFent : EPAR - Summary for the public SL = slovenščina 2010-09-14 2014-04-14
PecFent : EPAR - Summary for the public FI = suomi 2010-09-14 2014-04-14
PecFent : EPAR - Summary for the public SV = svenska 2010-09-14 2014-04-14
PecFent : EPAR - Summary for the public HR = Hrvatski 2010-09-14 2014-04-14

This EPAR was last updated on 08/09/2016 .

Authorisation details

Product details

Product details for PecFent
NamePecFent
Agency product numberEMEA/H/C/001164
Active substance

fentanyl

International non-proprietary name (INN) or common name

fentanyl

Therapeutic area PainCancer
Anatomical therapeutic chemical (ATC) code N02AB03
Generic

A generic medicine is a medicine which is similar to a medicine that has already been authorised (the 'reference medicine'). A generic medicine contains the same quantity of active substance(s) as the reference medicine. Generic and reference medicines are used at the same dose to treat the same disease, and they are equally safe and effective.

Publication details

Publication details for PecFent
Marketing-authorisation holder

Archimedes Development Ltd

Revision11
Date of issue of marketing authorisation valid throughout the European Union31/08/2010

Contact address:

Archimedes Development Ltd
Albert Einstein Centre
Nottingham Science and Technology Park
University Boulevard
Nottingham
NG7 2TN
United Kingdom

Product information

Product information

15/08/2016  PecFent -EMEA/H/C/001164 -N/0039

Name Language First published Last updated
PecFent : EPAR - Product Information HR = Hrvatski 2010-09-14 2016-09-08
PecFent : EPAR - Product Information HR = Hrvatski 2010-09-14 2016-09-08
PecFent : EPAR - Product Information HR = Hrvatski 2010-09-14 2016-09-08
PecFent : EPAR - Product Information HR = Hrvatski 2010-09-14 2016-09-08
PecFent : EPAR - Product Information HR = Hrvatski 2010-09-14 2016-09-08
PecFent : EPAR - Product Information HR = Hrvatski 2010-09-14 2016-09-08
PecFent : EPAR - Product Information HR = Hrvatski 2010-09-14 2016-09-08
PecFent : EPAR - Product Information HR = Hrvatski 2010-09-14 2016-09-08
PecFent : EPAR - Product Information HR = Hrvatski 2010-09-14 2016-09-08
PecFent : EPAR - Product Information HR = Hrvatski 2010-09-14 2016-09-08
PecFent : EPAR - Product Information HR = Hrvatski 2010-09-14 2016-09-08
PecFent : EPAR - Product Information HR = Hrvatski 2010-09-14 2016-09-08
PecFent : EPAR - Product Information HR = Hrvatski 2010-09-14 2016-09-08
PecFent : EPAR - Product Information HR = Hrvatski 2010-09-14 2016-09-08
PecFent : EPAR - Product Information HR = Hrvatski 2010-09-14 2016-09-08
PecFent : EPAR - Product Information HR = Hrvatski 2010-09-14 2016-09-08
PecFent : EPAR - Product Information HR = Hrvatski 2010-09-14 2016-09-08
PecFent : EPAR - Product Information HR = Hrvatski 2010-09-14 2016-09-08
PecFent : EPAR - Product Information HR = Hrvatski 2010-09-14 2016-09-08
PecFent : EPAR - Product Information HR = Hrvatski 2010-09-14 2016-09-08
PecFent : EPAR - Product Information HR = Hrvatski 2010-09-14 2016-09-08
PecFent : EPAR - Product Information HR = Hrvatski 2010-09-14 2016-09-08
PecFent : EPAR - Product Information HR = Hrvatski 2010-09-14 2016-09-08
PecFent : EPAR - Product Information HR = Hrvatski 2010-09-14 2016-09-08
PecFent : EPAR - Product Information HR = Hrvatski 2010-09-14 2016-09-08

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
PecFent : EPAR - All Authorised presentations HR = Hrvatski 2010-09-14 2016-07-28
PecFent : EPAR - All Authorised presentations HR = Hrvatski 2010-09-14 2016-07-28
PecFent : EPAR - All Authorised presentations HR = Hrvatski 2010-09-14 2016-07-28
PecFent : EPAR - All Authorised presentations HR = Hrvatski 2010-09-14 2016-07-28
PecFent : EPAR - All Authorised presentations HR = Hrvatski 2010-09-14 2016-07-28
PecFent : EPAR - All Authorised presentations HR = Hrvatski 2010-09-14 2016-07-28
PecFent : EPAR - All Authorised presentations HR = Hrvatski 2010-09-14 2016-07-28
PecFent : EPAR - All Authorised presentations HR = Hrvatski 2010-09-14 2016-07-28
PecFent : EPAR - All Authorised presentations HR = Hrvatski 2010-09-14 2016-07-28
PecFent : EPAR - All Authorised presentations HR = Hrvatski 2010-09-14 2016-07-28
PecFent : EPAR - All Authorised presentations HR = Hrvatski 2010-09-14 2016-07-28
PecFent : EPAR - All Authorised presentations HR = Hrvatski 2010-09-14 2016-07-28
PecFent : EPAR - All Authorised presentations HR = Hrvatski 2010-09-14 2016-07-28
PecFent : EPAR - All Authorised presentations HR = Hrvatski 2010-09-14 2016-07-28
PecFent : EPAR - All Authorised presentations HR = Hrvatski 2010-09-14 2016-07-28
PecFent : EPAR - All Authorised presentations HR = Hrvatski 2010-09-14 2016-07-28
PecFent : EPAR - All Authorised presentations HR = Hrvatski 2010-09-14 2016-07-28
PecFent : EPAR - All Authorised presentations HR = Hrvatski 2010-09-14 2016-07-28
PecFent : EPAR - All Authorised presentations HR = Hrvatski 2010-09-14 2016-07-28
PecFent : EPAR - All Authorised presentations HR = Hrvatski 2010-09-14 2016-07-28
PecFent : EPAR - All Authorised presentations HR = Hrvatski 2010-09-14 2016-07-28
PecFent : EPAR - All Authorised presentations HR = Hrvatski 2010-09-14 2016-07-28
PecFent : EPAR - All Authorised presentations HR = Hrvatski 2010-09-14 2016-07-28
PecFent : EPAR - All Authorised presentations HR = Hrvatski 2010-09-14 2016-07-28
PecFent : EPAR - All Authorised presentations HR = Hrvatski 2010-09-14 2016-07-28

Name Language First published Last updated
PecFent : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-09-14  
PecFent : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-09-14  
PecFent : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-09-14  
PecFent : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-09-14  
PecFent : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-09-14  
PecFent : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-09-14  
PecFent : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-09-14  
PecFent : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-09-14  
PecFent : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-09-14  
PecFent : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-09-14  
PecFent : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-09-14  
PecFent : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-09-14  
PecFent : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-09-14  
PecFent : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-09-14  
PecFent : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-09-14  
PecFent : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-09-14  
PecFent : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-09-14  
PecFent : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-09-14  
PecFent : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-09-14  
PecFent : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-09-14  
PecFent : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-09-14  
PecFent : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2010-09-14  

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.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
PecFent : EPAR - Public assessment report HR = Hrvatski 2010-09-14  
CHMP positive summary of opinion for PecFent HR = Hrvatski 2010-06-24  

Authorised

This medicine is approved for use in the European Union

More information on PecFent