{"entity":{"id":"fentanyl","kind":"drug","name":"Fentanyl (transmucosal, for breakthrough cancer pain)","aka":["fentanyl","fentanyl citrate","Effentora","Instanyl","PecFent"],"tldr":"These are fast-acting forms of the opioid fentanyl, taken as a tablet against the cheek or as a nasal spray, for sudden flares of pain in people whose cancer pain is otherwise controlled by a regular opioid. They are only for patients already tolerant to opioids.","summary":"Three centrally authorised fentanyl products are indicated for breakthrough pain in adults who are already receiving maintenance opioid therapy for chronic cancer pain, breakthrough pain being a transitory exacerbation on a background of otherwise controlled persistent pain: Effentora buccal tablets (authorised 4 April 2008; marketing authorisation holder Phoenix Labs Unlimited Company), Instanyl nasal spray (authorised 20 July 2009; Istituto Gentili S.r.l.) and PecFent nasal spray (authorised 31 August 2010; Gruenenthal GmbH). The EMA lists the therapeutic area as pain. This record covers the cancer-pain formulations only.","status":"approved","asOf":"2026-09-22","links":[{"label":"EMA: Effentora (EPAR)","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/effentora"},{"label":"EMA: Instanyl (EPAR)","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/instanyl"},{"label":"EMA: PecFent (EPAR)","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/pecfent"}],"tags":["ema-register","supportive"],"related":["methylnaltrexone"],"cancers":[],"sections":[],"technologies":["pain-management"],"targets":["oprm1"],"drugs":[],"companies":["gruenenthal"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo content wave 5 (EMA medicines register and EPAR pages)","editedOn":"2026-09-22"},"brand":"Effentora / Instanyl / PecFent","modality":"Small-molecule opioid analgesic (buccal tablet and nasal sprays)","mechanism":"Mu-opioid receptor agonist formulated for fast absorption through the mouth or nose, for breakthrough pain in adults already on maintenance opioid therapy for chronic cancer pain (indication wording, EMA).","approvals":[{"region":"EU","year":2008,"indication":"Breakthrough pain in adults receiving maintenance opioid therapy for chronic cancer pain","note":"Effentora authorised 4 Apr 2008 (Phoenix Labs); Instanyl 20 Jul 2009 (Istituto Gentili); PecFent 31 Aug 2010 (Gruenenthal)"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/fentanyl/","neighbours":{"drug":[{"id":"methylnaltrexone","kind":"drug","name":"Methylnaltrexone","route":"/drugs/methylnaltrexone/"}],"technology":[{"id":"pain-management","kind":"technology","name":"Cancer pain management","route":"/technologies/pain-management/"}],"target":[{"id":"oprm1","kind":"target","name":"Mu-opioid receptor","route":"/targets/oprm1/"}],"company":[{"id":"gruenenthal","kind":"company","name":"Grünenthal","route":"/companies/gruenenthal/"}]}}