PecFent Cancer Pain Treatment

Introduction

Archimedes Pharma Ltd. announces the decision by the Scottish Medicines Consortium (SMC) to accept PecFent (fentanyl pectin nasal spray) for use within NHS Scotland. PecFent is indicated for the treatment of breakthrough pain in adults who are already receiving maintenance opioid therapy for chronic cancer pain. Following the SMC clinical effectiveness and health economic review of the product, PecFent has been accepted for use in Scotland for breakthrough cancer pain (BTCP) patients unsuitable for short-acting oral opioids or as an alternative to other fentanyl preparations.

Main Digest

Archimedes Pharma is an international specialty pharmaceutical company focused on the oncology, pain, and critical care sectors. Archimedes Pharma is marketing an expanding portfolio of specialist products to hospital-based prescriber's in Europe and has established commercial organizations in the UK, US, France, Germany, Ireland, and Spain.

Jeffrey H. Buchalter, President and Chief Executive Officer of Archimedes Pharma, commented:

"This is a key outcome from one of Europe's foremost Health Technology Assessment agencies. The SMC's balanced review of PecFent's clinical effectiveness and health economic value supports Archimedes' belief that PecFent provides a real opportunity for patients, for healthcare professionals, and for payers to improve the management of breakthrough cancer pain and the cost effectiveness of that management. We welcome the decision by the SMC to accept PecFent for use within the NHS in Scotland."

Professor Marie Fallon, Edinburgh Cancer Research Center, commented:

"BTCP is a challenge for current treatment options as it can be so rapid in onset, of short duration and severe to excruciating in intensity. The launch of PecFent was long awaited and I am very pleased PecFent will be available in Scotland to provide another important treatment option for patients with this challenging condition. This option is definitely an advance in the delivery of breakthrough cancer pain relief."

Breakthrough cancer pain (BTCP) affects 24% to 95%[i] (average across all studies 62%) of all cancer patients with pain and is characterized by sudden, often unpredictable, episodes of intense pain that occur despite background pain medication. BTCP is rapid in onset, usually reaching maximum intensity in five minutes and lasting for 30 to 60 minutes. BTCP has a significant and often severe impact on patient's lives negatively impacting function, mode, and quality of life.[ii],[iii]

PecFent contains fentanyl, a highly potent opioid analgesic, and uses the Archimedes Pharma nasal drug delivery system PecSys to deliver fentanyl in a rapid but controlled manner, designed to help match the time course of the typical breakthrough pain episode. In two randomized, controlled, double blind, phase 3 clinical trials, PecFent demonstrated evidence of onset of pain relief as early as 5 minutes, as well as clinically meaningful pain relief from 10 minutes.[iv],[v],[vi]

PecFent

Archimedes Pharma's fentanyl pectin nasal spray, PecFent, is authorized in the European Union for the treatment of breakthrough pain in adults who are already receiving maintenance opioid therapy for chronic cancer pain. It is under review by the US Food and Drug Administration (FDA).

PecFent contains fentanyl, a highly potent opioid analgesic, and uses the Archimedes Pharma nasal drug delivery system PecSys to deliver fentanyl in a rapid, but controlled, manner, designed to help match the time course of a typical episode of breakthrough cancer pain.

In two randomized, controlled, double blind, phase 3 clinical trials, PecFent demonstrated evidence of onset of pain relief as early as five minutes, as well as clinically meaningful pain relief from ten minutes.[vii],[viii],[ix]. The PecSys technology avoids problems such as nasopharygeal dripping or swallowing of the drug solution.

In the clinical trial program, the use of PecFent in the treatment of breakthrough cancer pain was associated with the occurrence of adverse events typical of opioid medication in this population. The most frequently reported were vomiting, nausea, disease progression, and constipation. The majority of such events were mild to moderate in intensity and adverse effects assessed as treatment-related led to study withdrawal in 3.9% of patients.

References:

[i] Svendsen KB, Andersen S, Arnason S, et al. Breakthrough pain in malignant and non-malignant diseases: a review of prevalence, characteristics and mechanisms. Eur J Pain. 2005;9:195-206.

[ii] Portenoy R et al, Pain, 1999 81 129-34

[iii] Portenoy R et al, J Opioid Manag 2010 6(2) 109-16

[iv] Portenoy, R. Burton, A. Wallace, M. et al. The Efficacy, Onset of Action and Tolerability of Fentanyl Pectin Nasal Spray (FPNS) With PecSysA in the Treatment of Breakthrough Cancer Pain (BTCP): A Multicentre, Placebo- Controlled, Double-Blind Crossover Study. Poster presented at the 11th Congress of the European Association for Palliative Care (EAPC); 7-10 May 2009; Vienna, Austria.

[v] Burton, A. Wallace, M. Taylor, D. et al. Fentanyl Pectin Nasal Spray (FPNS) With PecSysA : Onset of Action, Consistency, and Acceptability in Breakthrough Cancer Pain (BTCP). Poster Presented at the Annual Meeting of the American Pain Society, 7-9 May 2009; San Diego, CA.

[vi] Fallon, M. Gatti, A. Davies, A. et al. Efficacy, Safety and Patient Acceptability of Fentanyl Pectin Nasal spray Compared with Immediate- Release Morphine Sulphate Tablets in the Treatment of Breakthrough Cancer Pain: A Multicentre, Double-Blind, Double-Dummy, Multiple-Crossover Study. Poster Presented at the joint 15th Congress of the European Cancer Organization and 34th Congress of the European Society for Medical Oncology; 20-24 September 2009; Berlin, Germany.

[vii] Portenoy, R. Burton, A. Wallace, M. et al. The Efficacy, Onset of Action and Tolerability of Fentanyl Pectin Nasal Spray (FPNS) With PecSysA in the Treatment of Breakthrough Cancer Pain (BTCP): A Multicentre, Placebo- Controlled, Double-Blind Crossover Study. Poster presented at the 11th Congress of the European Association for Palliative Care (EAPC); 7-10 May 2009; Vienna, Austria.

[viii] Burton, A. Wallace, M. Taylor, D. et al. Fentanyl Pectin Nasal Spray (FPNS) With PecSysA : Onset of Action, Consistency, and Acceptability in Breakthrough Cancer Pain (BTCP). Poster Presented at the Annual Meeting of the American Pain Society, 7-9 May 2009; San Diego, CA.

[ix] Fallon, M. Gatti, A. Davies, A. et al. Efficacy, Safety and Patient Acceptability of Fentanyl Pectin Nasal spray Compared with Immediate- Release Morphine Sulphate Tablets in the Treatment of Breakthrough Cancer Pain: A Multicentre, Double-Blind, Double-Dummy, Multiple-Crossover Study. Poster Presented at the joint 15th Congress of the European Cancer Organization and 34th Congress of the European Society for Medical Oncology; 20-24 September 2009; Berlin, Germany.

Attribution/Source(s):

This quality-reviewed publication was selected for publishing by the editors of Disabled World due to its significant relevance to the disability community. Originally authored by Archimedes Pharma Ltd, and published on 2011/01/17 (Edit Update: 2022/06/30), the content may have been edited for style, clarity, or brevity. For further details or clarifications, Archimedes Pharma Ltd can be contacted at bionity.com. NOTE: Disabled World does not provide any warranties or endorsements related to this article.

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