o

EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/142250/2014

EMEA/H/C/001164

EPAR summary for the public

PecFent

fentanyl

This document 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.

7 Westferry Circus • Canary Wharf • London E14 4HB • United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8416 E-mail info@ema.europa.eu Website www.ema.europa.eu

© European Medicines Agency, 2014. Reproduction is authorised provided the source is acknowledged.

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.

PecFent

EMA/142250/2014    Page 2/3

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.

The full EPAR for PecFent can be found on the Agency's website under EMA website/Find medicine/Human medicines/European Public Assessment Reports. For more information about treatment with PecFent, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 03-2014.

PecFent

EMA/142250/2014