Archimedes Pharma Launches PecFent(R) (fentanyl Pectin Nasal Spray) for The Treatment Of Breakthrough Cancer Pain In The UK

Main Category: Pain / Anesthetics
Also Included In: Cancer / Oncology
Article Date: 10 Oct 2010 - 0:00 PDT


Archimedes Pharma Ltd., a leading international specialty pharma company, announced that PecFent*, fentanyl pectin nasal spray indicated for the treatment of breakthrough cancer pain (BTCP) in adults who are already receiving maintenance opioid therapy for chronic cancer pain, is now available in the UK following the granting of a marketing authorisation by the European Medicines Agency (EMA).

BTCP is sudden, often unpredictable episodes of pain that are severe to excruciating in intensity, and occur in people who are already taking strong, opioid pain killers for cancer pain. BTCP affects 24% to 95% (average across studies 62%) of all cancer patients with pain, despite background pain medication.1 Episodes can often reach maximum intensity within five minutes, and typically last 30-60 minutes. Most people who have BTCP experience several episodes a day.2

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 randomised, 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 10 minutes.3,4,5

Jeffrey H. Buchalter, President and Chief Executive Officer of Archimedes Pharma, commented: "I'm delighted that we're in a position where we can make PecFent available to cancer patients in the UK and offer them and the healthcare professionals who care for them a real opportunity to improve the management of their cancer pain. This has been a development programme taking many years of hard work and investment from the company, and the approval of our lead product marks a significant milestone for Archimedes Pharma in our ongoing commitment to develop and market innovative products throughout Europe."

Professor Marie Fallon, Edinburgh Cancer Research Centre, 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 is long awaited and promises another important treatment option for patients with this devastating condition. I personally look forward to being able to prescribe PecFent, as I have patients who I know will benefit from this new product, which provides a real advance in the delivery of breakthrough cancer pain relief."

PecFent contains fentanyl, a strong opioid drug, which may cause serious adverse effects such as tolerance or dependence, respiratory depression and bradycardia, and the product must only be used in patients who are already on established maintenance opioid therapy and are therefore tolerant to opioids. Patients must be closely monitored in the titration process.

In the clinical trial programme, 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.

Archimedes Pharma submitted a New Drug Application (NDA) for PecFent with the US Food and Drug Administration (FDA) in August 2009 and is in the process of establishing its own US commercial organisation to market the drug in the US once approved.

*PecFent was previously known as NasalFent.

About PecFent®

Archimedes Pharma's fentanyl pectin citrate nasal spray, PecFent, is approved in the European Union for the treatment of breakthrough cancer pain in adults who are already receiving maintenance opioid therapy for chronic cancer pain.

PecFent is an aqueous fentanyl citrate solution utilising Archimedes Pharma's proprietary PecSys technology. The PecFent solution has a low viscosity and is easily delivered in a low volume of 100 microlitres using a nasal spray pump. The pump produces a fine mist of similarly sized spray droplets that are deposited into the front of the nose. The calcium ions present on the nasal mucosa cause the pectin in the solution to form a thin gel layer, which allows fentanyl to be retained on the nasal mucosa, allowing a rapid but controlled absorption into the systemic circulation. The PecSys™ technology avoids problems such as dripping or swallowing of the drug solution.

References

1. 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.

2. Portenoy RK, Hagen NA. Breakthrough pain: definition, prevalence and characteristics. Pain. 1990;41:273-281.

3. Portenoy, R. Burton, A. Wallace, M. et al. The Efficacy, Onset of Action and Tolerability of Fentanyl Pectin Nasal Spray (FPNS) With PecSys® 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.

4. Burton, A. Wallace, M. Taylor, D. et al. Fentanyl Pectin Nasal Spray (FPNS) With PecSys®: 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.

5. 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 Organisation and 34th Congress of the European Society for Medical Oncology; 20-24 September 2009; Berlin, Germany.

Source:
Archimedes Pharma

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