/PRNewswire/ — Archimedes Pharma Ltd., a leading international specialty pharma company, today announced the decision by the Scottish Medicines Consortium (SMC) to accept PecFent(R) (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.
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 payors 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 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 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% (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.
PecFent contains fentanyl, a highly potent opioid analgesic, and uses the Archimedes Pharma nasal drug delivery system PecSys(R) 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 5 minutes, as well as clinically meaningful pain relief from 10 minutes.
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 prescribers in Europe and has established commercial organizations in the UK, US, France, Germany, Ireland, and Spain.
Archimedes Pharma’s portfolio includes fentanyl pectin nasal spray, PecFent(R), authorized in Europe for the treatment of breakthrough pain in adults who are already receiving maintenance opioid therapy for chronic cancer pain, and which is under review by the US Food and Drug Administration (FDA).
For more information, please visit: http://www.archimedespharma.com.
Archimedes Pharma’s fentanyl pectin nasal spray, PecFent(R), 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)
In the clinical trial program, the use of PecFent(R) 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.
Please also refer to the complete Summary of Product Characteristics available at http://www.pecfent.com
SOURCE Archimedes Pharma Ltd
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